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出境医 / 临床实验 / MC-19PD1 CAR-T in Relapsed or Refractory B Cell Lymphoma

MC-19PD1 CAR-T in Relapsed or Refractory B Cell Lymphoma

Study Description
Brief Summary:
This is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of CD19-CAR-T cells in patients with relapsed or refractory B-cell lymphoma.

Condition or disease Intervention/treatment Phase
Lymphoma Biological: MC-19PD1 CAR-T cells Phase 1

Detailed Description:
In this single-center, open-label, nonrandomized, no control, prospective clinical trial, appoximately 15 relapsed or refractory B-cell lymphoma patients will be enrolled. Side effects of CD19 CAR T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells therapy in patients with R/R B-cell lymphoma
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study Evaluating the Efficacy and Safety of MC-19PD1 CAR-T in Relapsed or Refractory B Cell Lymphoma
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: MC-19PD1 CAR-T Cells Biological: MC-19PD1 CAR-T cells
T cells purified from the PBMC of subjects, transduced with anti-CD19 CAR and PD1/CD28 chimera lentiviral vector, expanded in vitro for future administration.
Outcome Measures
Primary Outcome Measures :
  1. Percentage of adverse events [ Time Frame: 2 years ]
    Percentage of participants with adverse events


Secondary Outcome Measures :
  1. objective remission rate [ Time Frame: 3 months ]
    The percentage of participants who achieved complete remission (CR) and partial remission over all participants (ORR)


Eligibility Criteria
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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）CD19 positive B-cell lymphoma; （2）Relapsed and refractory B-cell lymphoma: patients previously received at least first-line and second- line treatment and fail to achieve CR; （3）At least 1 measurable tumor foci according to the 2014 Lugano treatment response criteria; （4）18 to 70 Years Old, Male and female; （5）Expected to survive for more than 3 months; （6）Clinical performance status of ECOG score 0-1; （7）Important organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥50%; serum Cr ≤ 1.25 times normal range or creatinine clearance calculated by Cockcroft-Gault formula ≥45ml/min; ALT and AST≤ 3 times normal range, total bilirubin ≤ 1.5times normal range; （8）hemoglobin ≥ 80 g / L, neutrophils ≥ 1.0 × 10 ^ 9 / L, platelets ≥ 50 × 10 ^ 9 / L.

（9）INR≤ 1.5times normal range; APTT≤ 1.5times normal range; （10）Women in childbearing age must be not pregnant and do not plan pregnancy within 1 year of their cell transfusion; （11）Informed consent is signed by a subject or his lineal relation.

Exclusion Criteria:

  1. Recent or current use of glucocorticoid or other immunosuppressor or Drug that stimulates bone marrow hematopoiesis;
  2. Uncontrolled systemic active infection: fungi, bacteria, viruses or other infections;
  3. Active infection with HBV, HCV or HIV;
  4. Patients with symptoms and disease history of central nervous system;
  5. Pregnant or lactating female；The patient did not agree to use effective contraception during the treatment period and for the following 1 year；
  6. Patients receiving allogeneic hematopoietic stem cell transplantation, or organ transplantation
  7. A history of other malignant tumors;
  8. Primary immunodeficiency disease, or autoimmune disease;
  9. Patients treated with PD-1 inhibitors or PD-L1 inhibitors prior to enrollment;
  10. Patients who participated in other clinical trials within 4 weeks before blood collection;
  11. Patients who had used CD19 targeted therapy before enrollment;
  12. The investigator believes that there are other factors that are not suitable for inclusion or influence the subject's participation or completion of the study.
Contacts and Locations

Contacts
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Contact: Chaoting Zhang, PhD 86-010-88196768 zhangchaoting1@163.com

Locations
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China, Beijing
Peking University Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Yuqin Song, PhD    0086 ‭13683398726‬    songyuqin622@163.com   
Sponsors and Collaborators
Peking University
Tracking Information
First Submitted Date  ICMJE April 22, 2019
First Posted Date  ICMJE May 1, 2019
Last Update Posted Date May 1, 2019
Estimated Study Start Date  ICMJE May 1, 2019
Estimated Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2019) 		Percentage of adverse events [ Time Frame: 2 years ]
Percentage of participants with adverse events
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2019) 		objective remission rate [ Time Frame: 3 months ]
The percentage of participants who achieved complete remission (CR) and partial remission over all participants (ORR)
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 MC-19PD1 CAR-T in Relapsed or Refractory B Cell Lymphoma
Official Title  ICMJE Study Evaluating the Efficacy and Safety of MC-19PD1 CAR-T in Relapsed or Refractory B Cell Lymphoma
Brief Summary This is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of CD19-CAR-T cells in patients with relapsed or refractory B-cell lymphoma.
Detailed Description In this single-center, open-label, nonrandomized, no control, prospective clinical trial, appoximately 15 relapsed or refractory B-cell lymphoma patients will be enrolled. Side effects of CD19 CAR T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells therapy in patients with R/R B-cell lymphoma
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma
Intervention  ICMJE Biological: MC-19PD1 CAR-T cells
T cells purified from the PBMC of subjects, transduced with anti-CD19 CAR and PD1/CD28 chimera lentiviral vector, expanded in vitro for future administration.
Study Arms  ICMJE Experimental: MC-19PD1 CAR-T Cells
Intervention: Biological: MC-19PD1 CAR-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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 29, 2019) 		15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2021
Estimated Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

（1）CD19 positive B-cell lymphoma; （2）Relapsed and refractory B-cell lymphoma: patients previously received at least first-line and second- line treatment and fail to achieve CR; （3）At least 1 measurable tumor foci according to the 2014 Lugano treatment response criteria; （4）18 to 70 Years Old, Male and female; （5）Expected to survive for more than 3 months; （6）Clinical performance status of ECOG score 0-1; （7）Important organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥50%; serum Cr ≤ 1.25 times normal range or creatinine clearance calculated by Cockcroft-Gault formula ≥45ml/min; ALT and AST≤ 3 times normal range, total bilirubin ≤ 1.5times normal range; （8）hemoglobin ≥ 80 g / L, neutrophils ≥ 1.0 × 10 ^ 9 / L, platelets ≥ 50 × 10 ^ 9 / L.

（9）INR≤ 1.5times normal range; APTT≤ 1.5times normal range; （10）Women in childbearing age must be not pregnant and do not plan pregnancy within 1 year of their cell transfusion; （11）Informed consent is signed by a subject or his lineal relation.

Exclusion Criteria:

  1. Recent or current use of glucocorticoid or other immunosuppressor or Drug that stimulates bone marrow hematopoiesis;
  2. Uncontrolled systemic active infection: fungi, bacteria, viruses or other infections;
  3. Active infection with HBV, HCV or HIV;
  4. Patients with symptoms and disease history of central nervous system;
  5. Pregnant or lactating female；The patient did not agree to use effective contraception during the treatment period and for the following 1 year；
  6. Patients receiving allogeneic hematopoietic stem cell transplantation, or organ transplantation
  7. A history of other malignant tumors;
  8. Primary immunodeficiency disease, or autoimmune disease;
  9. Patients treated with PD-1 inhibitors or PD-L1 inhibitors prior to enrollment;
  10. Patients who participated in other clinical trials within 4 weeks before blood collection;
  11. Patients who had used CD19 targeted therapy before enrollment;
  12. The investigator believes that there are other factors that are not suitable for inclusion or influence the subject's participation or completion of the study.
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03932955
Other Study ID Numbers  ICMJE MC-19PD1 CART201902
Has Data Monitoring Committee Not Provided
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: Undecided
Responsible Party Jun Zhu, Peking University
Study Sponsor  ICMJE Peking University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Peking University
Verification Date April 2019

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

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