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CD19/CD20 Dual-CAR-T in B-cell Lymphoma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04260932
Recruitment Status : Recruiting
First Posted : February 7, 2020
Last Update Posted : March 23, 2021
Sponsor:
Collaborator:
China Immunotech (Beijing) Biotechnology Co., Ltd.
Information provided by (Responsible Party):
Hebei Yanda Ludaopei Hospital

Tracking Information
First Submitted Date  ICMJE February 6, 2020
First Posted Date  ICMJE February 7, 2020
Last Update Posted Date March 23, 2021
Actual Study Start Date  ICMJE February 7, 2020
Estimated Primary Completion Date August 10, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2020)
  • Percentage of participants with adverse events. [ Time Frame: 6 months ]
  • 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: February 6, 2020)
  • 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/CD20 Dual-CAR-T in B-cell Lymphoma Patients
Official Title  ICMJE CD19/CD20 Dual-CAR-T for Patients With B-cell Lymphoma
Brief Summary This is a single center, single arm, open-label, phase I study to evaluate the safety and efficacy of CD19/CD20 Dual-CAR-T cells in patients with refractory and relapsed B-cell lymphoma.
Detailed Description This Phase I study is designed as a pilot trial evaluating the safety and efficacy of CD19/CD20 Dual-CAR-T cell therapy in subjects with refractory and relapsed B cell lymphoma. Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3 followed by infusion of CD19/CD20 Dual-CAR-T cells. Safety and efficacy of CD19/CD20 Dual-CAR-T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19/CD20 Dual-CAR-T cells therapy in patients with refractory and relapsed 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 B-cell Lymphoma
Intervention  ICMJE Biological: CD19/CD20 Dual-CAR-T cells
CD19/CD20 Dual-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 at least for 2 days before infusion. CD19/CD20 Dual-CAR-T cells will be intravenously infused with a escalated dose of 1-6×106 cells/kg.
Study Arms  ICMJE Experimental: CD19/CD20 Dual-CAR-T cells
CD19/CD20 Dual-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 at least 2 days before infusion.
Intervention: Biological: CD19/CD20 Dual-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: February 6, 2020)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 10, 2021
Estimated Primary Completion Date August 10, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Relapsed and refractory B-cell lymphoma with:

    Relapsed or refractory disease after ≥2 lines of chemotherapy including rituximab and anthracycline and either having failed after autologous or allogeneic hematopoietic stem cell transplantation (ASCT);

  2. Patients must have evaluable evidence of disease, including minimal residual disease (MRD);
  3. Double positive expression of CD19 / CD20 in B cells;
  4. Ages 1 to 80 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;
  7. Patients who voluntarily sign informed consent and are willing to comply with treatment plans.

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. intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation;
  7. pregnant or lactating women;
  8. The patient does not agree to use effective contraception during the treatment period and for the next 3 months;
  9. Patients who participate in other clinical studies at the same time;
  10. 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 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xian Zhang, PhD 010-80841201 zhxian2@126.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04260932
Other Study ID Numbers  ICMJE HXYT-006
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.
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