Clinical Trials /

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

NCT04260932

Description:

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.

Related Conditions:
  • B-Cell Non-Hodgkin Lymphoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: CD19/CD20 Dual-CAR-T in B-cell Lymphoma Patients
  • Official Title: CD19/CD20 Dual-CAR-T for Patients With B-cell Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: LDP-DC-001
  • NCT ID: NCT04260932

Conditions

  • B-cell Lymphoma

Interventions

DrugSynonymsArms
CD19/CD20 Dual-CAR-T cellsCD19/CD20 Dual-CAR-T cells

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
CD19/CD20 Dual-CAR-T cellsExperimentalCD19/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.
  • CD19/CD20 Dual-CAR-T cells

Eligibility Criteria

        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.
      
Maximum Eligible Age:80 Years
Minimum Eligible Age:1 Year
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Percentage of participants with adverse events.
Time Frame:6 months
Safety Issue:
Description:The percentage of participants who achieved complete remission (CR) and partial remission over all participants.

Secondary Outcome Measures

Measure:Relapse-Free Survival(RFS )
Time Frame:6 months
Safety Issue:
Description:
Measure:Overall-Survival(OS)
Time Frame:6 months
Safety Issue:
Description:
Measure:Persistence of CAR-T cells in vivo
Time Frame:6 months
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Hebei Yanda Ludaopei Hospital

Last Updated

February 6, 2020