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

Sponsor
Hebei Yanda Ludaopei Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04260932
Collaborator
China Immunotech (Beijing) Biotechnology Co., Ltd. (Industry)
12
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1
18.3
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: CD19/CD20 Dual-CAR-T cells
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
CD19/CD20 Dual-CAR-T for Patients With B-cell Lymphoma
Actual Study Start Date :
Mar 1, 2020
Actual Primary Completion Date :
May 10, 2021
Actual Study Completion Date :
Sep 10, 2021

Arms and Interventions

Arm Intervention/Treatment
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.

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.

Outcome Measures

Primary Outcome Measures

  1. Percentage of participants with adverse events. [6 months]

  2. Objective remission rate(ORR) [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 ) [6 months]

  2. Overall-Survival(OS) [6 months]

  3. Persistence of CAR-T cells in vivo [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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);

  1. Patients must have evaluable evidence of disease, including minimal residual disease (MRD);

  2. Double positive expression of CD19 / CD20 in B cells;

  3. Ages 1 to 80 years, including boundary values;

  4. ECOG score 0-3 points;

  5. 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;

  6. 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;

  1. Active infections that are difficult to control;

  2. Human immunodeficiency virus (HIV) positive;

  3. Liver and kidney function: total bilirubin > 5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 5 × ULN, serum creatinine clearance rate 60mL / min;

  4. GVHD ≥ 2 or anti-GVHD treatment;

  5. intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation;

  6. pregnant or lactating women;

  7. The patient does not agree to use effective contraception during the treatment period and for the next 3 months;

  8. Patients who participate in other clinical studies at the same time;

  9. 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

Locations

Site City State Country Postal Code
1 Hebei Yanda Ludaopei Hospital Sanhe Hebei China 065200

Sponsors and Collaborators

  • Hebei Yanda Ludaopei Hospital
  • China Immunotech (Beijing) Biotechnology Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hebei Yanda Ludaopei Hospital
ClinicalTrials.gov Identifier:
NCT04260932
Other Study ID Numbers:
  • HXYT-006
First Posted:
Feb 7, 2020
Last Update Posted:
Mar 8, 2022
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 8, 2022