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出境医 / 临床实验 / CD19-CAR-T in B-cell Malignancies Patients

CD19-CAR-T in B-cell Malignancies Patients

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

Condition or disease Intervention/treatment Phase
B-cell Malignancy Biological: CD19-CAR-T cells Phase 1

Detailed Description:
This Phase I study is designed as a pilot trial evaluating the safety and of CD19-CAR-T cell therapy in subjects with refractory and relapsed B cell malignancies. Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3 followed by infusion of CD19-CAR-T cells. Safety and efficacy 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 refractory and relapsed B-cell malignancies.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CD19-CAR-T for Patients With B Cell Malignancies
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : October 31, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: CD19-CAR-T cells
CD19-CAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of CAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest for 2 days before infusion.
 Biological: CD19-CAR-T cells
CD19-CAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of CAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest for 2 days before infusion.
Outcome Measures
Primary Outcome Measures :
  1. Percentage of adverse events [ Time Frame: 6 months ]
    Percentage of participants with adverse events.

  2. Objective remission rate(ORR) [ Time Frame: 6 months ]
    The percentage of participants who achieved complete remission (CR) and partial remission over all participants.


Secondary Outcome Measures :
  1. Relapse-Free Survival(RFS ) [ Time Frame: 6 months ]
  2. Overall-Survival(OS) [ Time Frame: 6 months ]
  3. Persistence of CAR-T cells in vivo [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   1 Year to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Relapsed and refractory CD19 positive B-cell acute malignancies with:

    • Relapsed after competed remission, could not get competed remission after at more than 1 course of chemotherapy (including MRD≥0.1%);
    • MRD≥0.1% after allogeneic hematopoietic stem cell transplantation(HSCT), or recurrence after complete remission or MRD ≥ 0.1% after HSCT;
    • Refractory: at least two courses of chemotherapy did not achieve complete remission or MRD ≥ 0.1%;
  2. Patients must have evaluable evidence of disease, including minimal residual disease (MRD);
  3. Ph + patients who meet the following criteria can register:Failure to tolerate TKI or TKI treatment failure, or failure to transplant;
  4. Ages 1 to 70 years, including boundary values;
  5. ECOG score 0-3 points;
  6. Women of childbearing age (15-49 years old) must receive a pregnancy test within 7 days prior to initiation of treatment and the results are negative; male and female patients with fertility must use an effective contraceptive to ensure 3 months after discontinuation of treatment during the study period not pregnant inside.

Exclusion Criteria:

  1. patients with organ failure:

    • Heart: NYHA heart function grade IV;
    • Liver: Grade C that achieves Child-Turcotte liver function grading;
    • Kidney: kidney failure and uremia;
    • Lung: symptoms of respiratory failure;
    • Brain: a person with a disability;
  2. Active infections that are difficult to control;
  3. Human immunodeficiency virus (HIV) positive;
  4. Liver and kidney function: total bilirubin > 5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 5 × ULN, serum creatinine clearance rate 60mL / min;
  5. GVHD ≥ 2 or anti-GVHD treatment;
  6. Received allogeneic cell therapy within 4 weeks, such as donor lymphocyte infusion;
  7. Subject received anti-tumor treatment (chemotherapy, mAb, or hormone) for less than 1 week;
  8. Central nervous system white blood that is symptomatic or uncontrolled by systemic chemotherapy and intrathecal chemotherapy (a large number of tumor cells in CSF, white blood cell count >15WBCs/mL);
  9. intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation;
  10. pregnant or lactating women;
  11. The patient does not agree to use effective contraception during the treatment period and for the next 3 months;
  12. Patients who participate in other clinical studies at the same time;
  13. 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: XIAN ZHANG, PhD +8613641041596 zhxian2@126.com

Locations
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China, Hebei
Hebei Yanda Ludaopei Hospital Recruiting
Sanhe, Hebei, China, 065200
Contact: XIAN ZHANG, PhD    +8613641041596    zhxian2@126.com   
Sponsors and Collaborators
Hebei Yanda Ludaopei Hospital
China Immunotech (Beijing) Biotechnology Co., Ltd.
Avalon GloboCare Corp.
Tracking Information
First Submitted Date  ICMJE February 25, 2019
First Posted Date  ICMJE May 16, 2019
Last Update Posted Date August 12, 2020
Actual Study Start Date  ICMJE August 1, 2019
Estimated Primary Completion Date July 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2019)
  • Percentage of adverse events [ Time Frame: 6 months ]
    Percentage of participants with adverse events.
  • Objective remission rate(ORR) [ Time Frame: 6 months ]
    The percentage of participants who achieved complete remission (CR) and partial remission over all participants.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2019)
  • Relapse-Free Survival(RFS ) [ Time Frame: 6 months ]
  • Overall-Survival(OS) [ Time Frame: 6 months ]
  • Persistence of CAR-T cells in vivo [ Time Frame: 6 months ]
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 CD19-CAR-T in B-cell Malignancies Patients
Official Title  ICMJE CD19-CAR-T for Patients With B Cell Malignancies
Brief Summary This is a single center, single arm, open-lable phase I study to determine the safety and efficacy of CD19-CAR-T cells in patients with refractory and relapsed B-cell malignancies.
Detailed Description This Phase I study is designed as a pilot trial evaluating the safety and of CD19-CAR-T cell therapy in subjects with refractory and relapsed B cell malignancies. Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3 followed by infusion of CD19-CAR-T cells. Safety and efficacy 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 refractory and relapsed B-cell malignancies.
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 B-cell Malignancy
Intervention  ICMJE Biological: CD19-CAR-T cells
CD19-CAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of CAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest for 2 days before infusion.
Study Arms  ICMJE Experimental: CD19-CAR-T cells
CD19-CAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of CAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest for 2 days before infusion.
Intervention: Biological: CD19-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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 15, 2019) 		20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2021
Estimated Primary Completion Date July 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Relapsed and refractory CD19 positive B-cell acute malignancies with:

    • Relapsed after competed remission, could not get competed remission after at more than 1 course of chemotherapy (including MRD≥0.1%);
    • MRD≥0.1% after allogeneic hematopoietic stem cell transplantation(HSCT), or recurrence after complete remission or MRD ≥ 0.1% after HSCT;
    • Refractory: at least two courses of chemotherapy did not achieve complete remission or MRD ≥ 0.1%;
  2. Patients must have evaluable evidence of disease, including minimal residual disease (MRD);
  3. Ph + patients who meet the following criteria can register:Failure to tolerate TKI or TKI treatment failure, or failure to transplant;
  4. Ages 1 to 70 years, including boundary values;
  5. ECOG score 0-3 points;
  6. Women of childbearing age (15-49 years old) must receive a pregnancy test within 7 days prior to initiation of treatment and the results are negative; male and female patients with fertility must use an effective contraceptive to ensure 3 months after discontinuation of treatment during the study period not pregnant inside.

Exclusion Criteria:

  1. patients with organ failure:

    • Heart: NYHA heart function grade IV;
    • Liver: Grade C that achieves Child-Turcotte liver function grading;
    • Kidney: kidney failure and uremia;
    • Lung: symptoms of respiratory failure;
    • Brain: a person with a disability;
  2. Active infections that are difficult to control;
  3. Human immunodeficiency virus (HIV) positive;
  4. Liver and kidney function: total bilirubin > 5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 5 × ULN, serum creatinine clearance rate 60mL / min;
  5. GVHD ≥ 2 or anti-GVHD treatment;
  6. Received allogeneic cell therapy within 4 weeks, such as donor lymphocyte infusion;
  7. Subject received anti-tumor treatment (chemotherapy, mAb, or hormone) for less than 1 week;
  8. Central nervous system white blood that is symptomatic or uncontrolled by systemic chemotherapy and intrathecal chemotherapy (a large number of tumor cells in CSF, white blood cell count >15WBCs/mL);
  9. intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation;
  10. pregnant or lactating women;
  11. The patient does not agree to use effective contraception during the treatment period and for the next 3 months;
  12. Patients who participate in other clinical studies at the same time;
  13. 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 1 Year to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: XIAN ZHANG, PhD +8613641041596 zhxian2@126.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03952923
Other Study ID Numbers  ICMJE HXYT-002
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 Not Provided
Responsible Party Hebei Yanda Ludaopei Hospital
Study Sponsor  ICMJE Hebei Yanda Ludaopei Hospital
Collaborators  ICMJE
  • China Immunotech (Beijing) Biotechnology Co., Ltd.
  • Avalon GloboCare Corp.
Investigators  ICMJE Not Provided
PRS Account Hebei Yanda Ludaopei Hospital
Verification Date August 2020

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

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