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出境医 / 临床实验 / Clinical Trial to Evaluate CD19 CAR T (CT032) in Patients With Relapsed and/or Refractory Non-Hodgkin's B Cell Lymphoma

Clinical Trial to Evaluate CD19 CAR T (CT032) in Patients With Relapsed and/or Refractory Non-Hodgkin's B Cell Lymphoma

Study Description
Brief Summary:
This is an open-label, single arm study to evaluate the safety and tolerability of treatment with CT032 CAR-CD19 T in patients with relapsed and/or refractory non-Hodgkin's B cell lymphoma (R/R B-NHL).

Condition or disease Intervention/treatment Phase
Refractory B-Cell Non-Hodgkin Lymphoma Relapsed B-cell Non-Hodgkin Lymphoma Biological: CAR-CD19 T Cells Phase 1 Phase 2

Detailed Description:
This study is a single-arm, open label, phase I/II clinical trial to evaluate the safety, efficacy and cellular kinetics of CT032 CAR-CD19 T cells in patients with R/R B-NHL. The study is composed of two stages, Phase I stage is for dose escalation and recommendation of phase 2 dose, and Phase II stage is to verify the efficacy and safety of the dose proposed.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open, Multi-center Phase Ⅰ/II Clinical Study to Evaluate the Safety and Efficacy of CT032 Humanized CD19 Autologous Car T Cell Injection in Patients With Relapsed and/or Refractory Non-Hodgkin's B Cell Lymphoma
Actual Study Start Date : August 14, 2019
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : September 30, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: CAR-CD19-T Cells
The subjects are enrolled into 3 dose levels cohorts in sequence.
Biological: CAR-CD19 T Cells

The CAR- CD19 T cells (study drug) used in this study are chimeric antigen receptor specifically expressing T cells targeting CD19.

Fludarabine and Cyclophosphamide are used for lymphodepletion.


Outcome Measures
Primary Outcome Measures :
  1. Phase Ⅰ, Safety/Tolerability: Dose-limiting toxicity (DLT) [ Time Frame: 28 days post administration of CAR-T cells ]
    Dose-limiting toxicity (DLT)

  2. Phase Ⅰ, Safety/Tolerability: Maximum tolerated dose (MTD) [ Time Frame: 28 days post administration of CAR-T cells ]
    Maximum tolerated dose (MTD)

  3. Phase Ⅰ, Safety/Tolerability: Incidence and severity of Treatment emergent adverse events (TEAE) [ Time Frame: 28 days post administration of CAR-T cells ]
    Incidence and severity of Treatment emergent adverse events (TEAE)

  4. Phase Ⅰ, Safety/Tolerability: Incidence and severity of study treatment related AE [ Time Frame: through 2 months post administration of CAR-T cells ]
    Incidence and severity of AE related to study treatment

  5. Phase Ⅰ, Safety/Tolerability: Incidence and severity of AEs of special interest (cytokine release syndrome [CRS], CART-cell-related encephalopathy syndrome [CRES]) [ Time Frame: through 2 months post administration of CAR-T cells ]
    Incidence and severity of AEs of special interest (cytokine release syndrome [CRS], CART-cell-related encephalopathy syndrome [CRES])

  6. Phase Ⅰ, Safety/Tolerability: Incidence and severity of Dose-limiting toxicity (DLT) of dose escalation experiment [ Time Frame: 28 days after infusion ]
    Incidence and severity of Dose-limiting toxicity (DLT) of dose escalation experiment

  7. Phase Ⅰ, Safety/Tolerability: Recommended Phase II Dose (RP2D) [ Time Frame: through 2 months post administration of CAR-T cells ]
    Recommended Phase II Dose (RP2D)

  8. Phase Ⅱ, Efficacy: Overall Remission Rate (ORR) [ Time Frame: through 6 months post administration of CAR-T cells ]
    Overall Remission Rate (ORR) (Partial remission and complete remission rate after infusion of CT032 CAR-CD19 T cells)


Secondary Outcome Measures :
  1. Phase Ⅰ, Safety/Tolerability: Incidence and severity of Treatment emergent adverse events (TEAE) [ Time Frame: through 24 months post administration of CAR-T cells ]
    Incidence and severity of Treatment emergent adverse events (TEAE)

  2. Phase Ⅰ, Safety/Tolerability: Incidence and severity of study treatment related AE [ Time Frame: through 24 months post administration of CAR-T cells ]
    Incidence and severity of AE related to study treatment

  3. Phase Ⅰ, Safety/Tolerability: Cytokine (IL-2, IL-6,IL-8,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by MSD and CBA method [ Time Frame: through 24 months post administration of CAR-T-cells ]
    Cytokine (IL-2, IL-6,IL-8,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by MSD and CBA method

  4. Phase Ⅰ: the number of copies of CAR-CD19 T cells in peripheral blood genomes by qPCR method and CAR-CD19 T cells by flow cytometry method [ Time Frame: through 24 months post administration of CAR-T cells ]
    the number of copies of CAR-CD19 T cells in peripheral blood genomes by qPCR method and CAR-CD19 T cells by flow cytometry method

  5. Phase Ⅰ, Efficacy: Overall Remission Rate (ORR) [ Time Frame: through 24 months post administration of CAR-T cells ]
    Overall Remission Rate (ORR) (Partial remission and complete remission rate after infusion of CT032 CAR-CD19 T cells)

  6. Phase Ⅱ, Efficacy: complete response (CR) rate [ Time Frame: through 24 months post administration of CAR-T cells ]
    complete response (CR) rate

  7. Phase Ⅱ, Efficacy: duration of response (DOR) [ Time Frame: through 24 months post administration of CAR-T cells ]
    duration of response (DOR)

  8. Phase Ⅱ, Efficacy: time to response (TTR) [ Time Frame: through 24 months post administration of CAR-T cells ]
    time to response (TTR)

  9. Phase Ⅱ, Efficacy: progression-free survival (PFS) [ Time Frame: through 24 months post administration of CAR-T cells ]
    progression-free survival (PFS) time

  10. Phase Ⅱ, Efficacy: overall survival (OS) [ Time Frame: through 24 months post administration of CAR-T cells ]
    overall survival (OS) time

  11. Phase Ⅱ, Safety/Tolerability: Incidence and severity of Treatment emergent adverse events (TEAE) [ Time Frame: through 24 months post administration of CAR-T cells ]
    Incidence and severity of Treatment emergent adverse events (TEAE)

  12. Incidence and severity of o study treatment related AE [ Time Frame: through 24 months post administration of CAR-T cells ]
    Incidence and severity of AE related to study treatment

  13. Phase Ⅱ, Safety/Tolerability: Incidence and severity of AEs of special interest (CRS, CRES) [ Time Frame: through 24 months post administration of CAR-T cells ]
    Incidence and severity of AEs of special interest (CRS, CRES)

  14. Phase Ⅱ, Safety/Tolerability: Cytokine (IL-2, IL-6,IL-8,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by MSD and CBA method [ Time Frame: through 24 months post administration of CAR-T cells ]
    Cytokine (IL-2, IL-6,IL-8,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by MSD and CBA method

  15. Phase Ⅱ: the number of copies of CAR-CD19 T cells in peripheral blood genomes by qPCR method and CAR-CD19 T cells by flow cytometry method [ Time Frame: through 24 months post administration of CAR-T cells ]
    the number of copies of CAR-CD19 T cells in peripheral blood genomes by qPCR method and CAR-CD19 T cells by flow cytometry method


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The subject should participate in the clinical trial voluntarily, be fully aware of and informed of this study and sign informed consent (ICF), and be willing to follow and be able to complete all trial procedures;
  2. Age 18-70 years old, male or female;
  3. CD 19 positive, Relapsed and/or Refractory Diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma after the transformation of Relapsed and/or Refractory DLBCL subjects by histopathological and/or cytology diagnosis; At least received second-line systemic anticancer treatments containing rituximab (or other anti-CD20 drugs) and anthracene (including autologous hematopoietic stem cell transplantation) , and had progressive disease (PD) or relapse after the latest treatment.
  4. The Eastern Cooperative Oncology Group (ECOG) score is 0 or 1 point;
  5. The expected survival period is more than 12 weeks;
  6. Having sufficient venous pathways (for leukapheresis or intravenous blood collection) and no leukapheresis contraindications;
  7. At least one measurable lesion: the long axis >1.5 cm of the lymph node lesion, or the long axis >1.0 cm of the non-lymph node lesion;
  8. subject has adequate organ function at screening;
  9. Women of childbearing age must undergo a serum pregnancy test with negative results before screening and lymphodepletion preconditioning with fludarabine and cyclophosphamide, and are willing to use effective and reliable method of contraception for at least 1 year after T cell infusion;
  10. Male subjects who have an active sex life with a woman with reproductive potential must be willing to use very effective and reliable methods of contraception for at least 1 year after T cell infusion.

Exclusion Criteria:

If the subject meets any of the following criteria, he or she cannot participate in this trial:

  1. A history of severe allergies, or a history of allergies or intolerance to fludarabine, cyclophosphamide or tocilizumab, or a history of allergies or intolerance to CAR T cell cytosolic component, or a history of allergic to beta-caprolactam antibiotics;
  2. Received chemotherapy, targeted therapy, radiotherapy and other anti-tumor treatment within 14 days before peripheral blood mononuclear cells (PBMCs) collection;
  3. Previously received any target of CAR T treatment, or previously received CD19 targeted drug treatment;
  4. Has undergone allogeneic hematopoietic stem cell transplantation; autologous stem cell transplantation was received within 12 weeks before PBMCs collection;
  5. Other malignant neoplasms existed in the previous 5 years or at the same time, with the exception of breast/cervical in situ cancer, cured basal cell carcinoma and superficial bladder tumor (Ta, Tis, T1);
  6. Any uncontrollable active infection, including but not limited to active TB patients
  7. subjects who had received a therapeutic dose of systemic steroid drugs (prednisone >20mg/days or equivalent doses of other hormones) or other immunosuppressants within 7 days before PBMCs collection, with the exception of those who had recently or currently used inhaled steroids;
  8. Known to have active autoimmune diseases, including but not limited to psoriasis, rheumatoid arthritis, etc., that need long-term immunosuppressive therapy;
  9. Patients with refractory hyponatremia and/or hypokalemia;
  10. Known or existing primary or metastatic central nervous system lymphoma, or any other central neurological disease or clinically significant neurological examination with abnormal results (such as seizures, cerebrovascular ischemia/hemorrhage, dementia, etc.);
  11. Within 6 months prior to signing the ICF, there were any of the uncontrolled cardiovascular, cerebral vascular disease, diabetes and pulmonary embolism, or other disease at discretion of investigators that participating in this clinical trial may harm the health of the subjects;
  12. Oxygen absorption before PBMCs collection to maintain blood oxygen saturation >95% (finger vein oxygen);
  13. According to the investigator, any serious or uncontrollable systemic disease, systematic comorbidities, other serious concurrent diseases (such as hemophagocytic syndrome, etc.), special circumstances of the tumor may make the subjects inappropriate to enter the study or non-compliant to the protocol, or produce significant interference to correct evaluation of study drug safety, toxicity, and validity;
  14. The investigators assessed that the subjects were unable or unwilling to comply with the requirements of the research protocol;
  15. Major surgical operations were performed within 4 weeks of the group (the definition of major surgery is based on the 3 and 4 levels of surgery specified in the measures for the administration of clinical application of medical technology); or has not yet been fully recovered from any previous invasive operation;
  16. The toxic response of previous anti-tumor therapy has not been restored to level 1 according to the Common Terminology Criteria for Adverse Events (CTCAE), except for hair loss and;
  17. Having participated in any other interventional clinical trial before administration, where the last time of drug administration is within 4 weeks or less than 5 half-lives of the test drug (the longer);
  18. Women who have been pregnant, prepared for pregnancy during the trial, or are breastfeeding; or women of childbearing age and fertile men who are unwilling or unable to adopt medically recognized and effective contraceptive methods throughout the study period;
  19. The investigator or a relative of his staff, a subject who may have an interest in it with the investigator or his staff.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Zonghai Li, Dr. 86-21-64355922 zonghaili@carsgen.com
Contact: Zaiwen Liu 86-17717520326 zaiwenliu@carsgen.com

Locations
Layout table for location information
China, Shanghai
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine Not yet recruiting
Shanghai, Shanghai, China, 200127
Contact: Honghui Huang, Dr.         
Principal Investigator: Honghui Huang, Dr.         
China, Zhejiang
First Affiliated Hospital of Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310003
Contact: Jie Jin, Dr.    86-571-87236702    jiej0503@163.com   
Principal Investigator: Jie Jin, Dr.         
Sub-Investigator: Wenjuan Yu, Dr.         
Sponsors and Collaborators
Carsgen Therapeutics, Ltd.
First Affiliated Hospital of Zhejiang University
RenJi Hospital
Investigators
Layout table for investigator information
Principal Investigator: Jie Jin, Dr. First Affiliated Hospital of Zhejiang University
Tracking Information
First Submitted Date  ICMJE June 12, 2019
First Posted Date  ICMJE June 21, 2019
Last Update Posted Date October 9, 2020
Actual Study Start Date  ICMJE August 14, 2019
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
  • Phase Ⅰ, Safety/Tolerability: Dose-limiting toxicity (DLT) [ Time Frame: 28 days post administration of CAR-T cells ]
    Dose-limiting toxicity (DLT)
  • Phase Ⅰ, Safety/Tolerability: Maximum tolerated dose (MTD) [ Time Frame: 28 days post administration of CAR-T cells ]
    Maximum tolerated dose (MTD)
  • Phase Ⅰ, Safety/Tolerability: Incidence and severity of Treatment emergent adverse events (TEAE) [ Time Frame: 28 days post administration of CAR-T cells ]
    Incidence and severity of Treatment emergent adverse events (TEAE)
  • Phase Ⅰ, Safety/Tolerability: Incidence and severity of study treatment related AE [ Time Frame: through 2 months post administration of CAR-T cells ]
    Incidence and severity of AE related to study treatment
  • Phase Ⅰ, Safety/Tolerability: Incidence and severity of AEs of special interest (cytokine release syndrome [CRS], CART-cell-related encephalopathy syndrome [CRES]) [ Time Frame: through 2 months post administration of CAR-T cells ]
    Incidence and severity of AEs of special interest (cytokine release syndrome [CRS], CART-cell-related encephalopathy syndrome [CRES])
  • Phase Ⅰ, Safety/Tolerability: Incidence and severity of Dose-limiting toxicity (DLT) of dose escalation experiment [ Time Frame: 28 days after infusion ]
    Incidence and severity of Dose-limiting toxicity (DLT) of dose escalation experiment
  • Phase Ⅰ, Safety/Tolerability: Recommended Phase II Dose (RP2D) [ Time Frame: through 2 months post administration of CAR-T cells ]
    Recommended Phase II Dose (RP2D)
  • Phase Ⅱ, Efficacy: Overall Remission Rate (ORR) [ Time Frame: through 6 months post administration of CAR-T cells ]
    Overall Remission Rate (ORR) (Partial remission and complete remission rate after infusion of CT032 CAR-CD19 T cells)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
  • Phase Ⅰ, Safety/Tolerability: Incidence and severity of Treatment emergent adverse events (TEAE) [ Time Frame: through 24 months post administration of CAR-T cells ]
    Incidence and severity of Treatment emergent adverse events (TEAE)
  • Phase Ⅰ, Safety/Tolerability: Incidence and severity of study treatment related AE [ Time Frame: through 24 months post administration of CAR-T cells ]
    Incidence and severity of AE related to study treatment
  • Phase Ⅰ, Safety/Tolerability: Cytokine (IL-2, IL-6,IL-8,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by MSD and CBA method [ Time Frame: through 24 months post administration of CAR-T-cells ]
    Cytokine (IL-2, IL-6,IL-8,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by MSD and CBA method
  • Phase Ⅰ: the number of copies of CAR-CD19 T cells in peripheral blood genomes by qPCR method and CAR-CD19 T cells by flow cytometry method [ Time Frame: through 24 months post administration of CAR-T cells ]
    the number of copies of CAR-CD19 T cells in peripheral blood genomes by qPCR method and CAR-CD19 T cells by flow cytometry method
  • Phase Ⅰ, Efficacy: Overall Remission Rate (ORR) [ Time Frame: through 24 months post administration of CAR-T cells ]
    Overall Remission Rate (ORR) (Partial remission and complete remission rate after infusion of CT032 CAR-CD19 T cells)
  • Phase Ⅱ, Efficacy: complete response (CR) rate [ Time Frame: through 24 months post administration of CAR-T cells ]
    complete response (CR) rate
  • Phase Ⅱ, Efficacy: duration of response (DOR) [ Time Frame: through 24 months post administration of CAR-T cells ]
    duration of response (DOR)
  • Phase Ⅱ, Efficacy: time to response (TTR) [ Time Frame: through 24 months post administration of CAR-T cells ]
    time to response (TTR)
  • Phase Ⅱ, Efficacy: progression-free survival (PFS) [ Time Frame: through 24 months post administration of CAR-T cells ]
    progression-free survival (PFS) time
  • Phase Ⅱ, Efficacy: overall survival (OS) [ Time Frame: through 24 months post administration of CAR-T cells ]
    overall survival (OS) time
  • Phase Ⅱ, Safety/Tolerability: Incidence and severity of Treatment emergent adverse events (TEAE) [ Time Frame: through 24 months post administration of CAR-T cells ]
    Incidence and severity of Treatment emergent adverse events (TEAE)
  • Incidence and severity of o study treatment related AE [ Time Frame: through 24 months post administration of CAR-T cells ]
    Incidence and severity of AE related to study treatment
  • Phase Ⅱ, Safety/Tolerability: Incidence and severity of AEs of special interest (CRS, CRES) [ Time Frame: through 24 months post administration of CAR-T cells ]
    Incidence and severity of AEs of special interest (CRS, CRES)
  • Phase Ⅱ, Safety/Tolerability: Cytokine (IL-2, IL-6,IL-8,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by MSD and CBA method [ Time Frame: through 24 months post administration of CAR-T cells ]
    Cytokine (IL-2, IL-6,IL-8,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by MSD and CBA method
  • Phase Ⅱ: the number of copies of CAR-CD19 T cells in peripheral blood genomes by qPCR method and CAR-CD19 T cells by flow cytometry method [ Time Frame: through 24 months post administration of CAR-T cells ]
    the number of copies of CAR-CD19 T cells in peripheral blood genomes by qPCR method and CAR-CD19 T cells by flow cytometry method
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial to Evaluate CD19 CAR T (CT032) in Patients With Relapsed and/or Refractory Non-Hodgkin's B Cell Lymphoma
Official Title  ICMJE An Open, Multi-center Phase Ⅰ/II Clinical Study to Evaluate the Safety and Efficacy of CT032 Humanized CD19 Autologous Car T Cell Injection in Patients With Relapsed and/or Refractory Non-Hodgkin's B Cell Lymphoma
Brief Summary This is an open-label, single arm study to evaluate the safety and tolerability of treatment with CT032 CAR-CD19 T in patients with relapsed and/or refractory non-Hodgkin's B cell lymphoma (R/R B-NHL).
Detailed Description This study is a single-arm, open label, phase I/II clinical trial to evaluate the safety, efficacy and cellular kinetics of CT032 CAR-CD19 T cells in patients with R/R B-NHL. The study is composed of two stages, Phase I stage is for dose escalation and recommendation of phase 2 dose, and Phase II stage is to verify the efficacy and safety of the dose proposed.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Refractory B-Cell Non-Hodgkin Lymphoma
  • Relapsed B-cell Non-Hodgkin Lymphoma
Intervention  ICMJE Biological: CAR-CD19 T Cells

The CAR- CD19 T cells (study drug) used in this study are chimeric antigen receptor specifically expressing T cells targeting CD19.

Fludarabine and Cyclophosphamide are used for lymphodepletion.

Study Arms  ICMJE Experimental: CAR-CD19-T Cells
The subjects are enrolled into 3 dose levels cohorts in sequence.
Intervention: Biological: CAR-CD19 T Cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 20, 2019)
78
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2022
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. The subject should participate in the clinical trial voluntarily, be fully aware of and informed of this study and sign informed consent (ICF), and be willing to follow and be able to complete all trial procedures;
  2. Age 18-70 years old, male or female;
  3. CD 19 positive, Relapsed and/or Refractory Diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma after the transformation of Relapsed and/or Refractory DLBCL subjects by histopathological and/or cytology diagnosis; At least received second-line systemic anticancer treatments containing rituximab (or other anti-CD20 drugs) and anthracene (including autologous hematopoietic stem cell transplantation) , and had progressive disease (PD) or relapse after the latest treatment.
  4. The Eastern Cooperative Oncology Group (ECOG) score is 0 or 1 point;
  5. The expected survival period is more than 12 weeks;
  6. Having sufficient venous pathways (for leukapheresis or intravenous blood collection) and no leukapheresis contraindications;
  7. At least one measurable lesion: the long axis >1.5 cm of the lymph node lesion, or the long axis >1.0 cm of the non-lymph node lesion;
  8. subject has adequate organ function at screening;
  9. Women of childbearing age must undergo a serum pregnancy test with negative results before screening and lymphodepletion preconditioning with fludarabine and cyclophosphamide, and are willing to use effective and reliable method of contraception for at least 1 year after T cell infusion;
  10. Male subjects who have an active sex life with a woman with reproductive potential must be willing to use very effective and reliable methods of contraception for at least 1 year after T cell infusion.

Exclusion Criteria:

If the subject meets any of the following criteria, he or she cannot participate in this trial:

  1. A history of severe allergies, or a history of allergies or intolerance to fludarabine, cyclophosphamide or tocilizumab, or a history of allergies or intolerance to CAR T cell cytosolic component, or a history of allergic to beta-caprolactam antibiotics;
  2. Received chemotherapy, targeted therapy, radiotherapy and other anti-tumor treatment within 14 days before peripheral blood mononuclear cells (PBMCs) collection;
  3. Previously received any target of CAR T treatment, or previously received CD19 targeted drug treatment;
  4. Has undergone allogeneic hematopoietic stem cell transplantation; autologous stem cell transplantation was received within 12 weeks before PBMCs collection;
  5. Other malignant neoplasms existed in the previous 5 years or at the same time, with the exception of breast/cervical in situ cancer, cured basal cell carcinoma and superficial bladder tumor (Ta, Tis, T1);
  6. Any uncontrollable active infection, including but not limited to active TB patients
  7. subjects who had received a therapeutic dose of systemic steroid drugs (prednisone >20mg/days or equivalent doses of other hormones) or other immunosuppressants within 7 days before PBMCs collection, with the exception of those who had recently or currently used inhaled steroids;
  8. Known to have active autoimmune diseases, including but not limited to psoriasis, rheumatoid arthritis, etc., that need long-term immunosuppressive therapy;
  9. Patients with refractory hyponatremia and/or hypokalemia;
  10. Known or existing primary or metastatic central nervous system lymphoma, or any other central neurological disease or clinically significant neurological examination with abnormal results (such as seizures, cerebrovascular ischemia/hemorrhage, dementia, etc.);
  11. Within 6 months prior to signing the ICF, there were any of the uncontrolled cardiovascular, cerebral vascular disease, diabetes and pulmonary embolism, or other disease at discretion of investigators that participating in this clinical trial may harm the health of the subjects;
  12. Oxygen absorption before PBMCs collection to maintain blood oxygen saturation >95% (finger vein oxygen);
  13. According to the investigator, any serious or uncontrollable systemic disease, systematic comorbidities, other serious concurrent diseases (such as hemophagocytic syndrome, etc.), special circumstances of the tumor may make the subjects inappropriate to enter the study or non-compliant to the protocol, or produce significant interference to correct evaluation of study drug safety, toxicity, and validity;
  14. The investigators assessed that the subjects were unable or unwilling to comply with the requirements of the research protocol;
  15. Major surgical operations were performed within 4 weeks of the group (the definition of major surgery is based on the 3 and 4 levels of surgery specified in the measures for the administration of clinical application of medical technology); or has not yet been fully recovered from any previous invasive operation;
  16. The toxic response of previous anti-tumor therapy has not been restored to level 1 according to the Common Terminology Criteria for Adverse Events (CTCAE), except for hair loss and;
  17. Having participated in any other interventional clinical trial before administration, where the last time of drug administration is within 4 weeks or less than 5 half-lives of the test drug (the longer);
  18. Women who have been pregnant, prepared for pregnancy during the trial, or are breastfeeding; or women of childbearing age and fertile men who are unwilling or unable to adopt medically recognized and effective contraceptive methods throughout the study period;
  19. The investigator or a relative of his staff, a subject who may have an interest in it with the investigator or his staff.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Zonghai Li, Dr. 86-21-64355922 zonghaili@carsgen.com
Contact: Zaiwen Liu 86-17717520326 zaiwenliu@carsgen.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03994913
Other Study ID Numbers  ICMJE CT032-NHL-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Carsgen Therapeutics, Ltd.
Study Sponsor  ICMJE Carsgen Therapeutics, Ltd.
Collaborators  ICMJE
  • First Affiliated Hospital of Zhejiang University
  • RenJi Hospital
Investigators  ICMJE
Principal Investigator: Jie Jin, Dr. First Affiliated Hospital of Zhejiang University
PRS Account Carsgen Therapeutics, Ltd.
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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