Clinical Trials /

Immunotherapy With Bispecific CAR-T Cells for B-Cell Lymphoma, ALL and CLL

NCT03271515

Description:

This study aims to evaluate the safety, efficacy and duration of response of anti-CD19 anti-CD20 Bispecific Chimeric Antigen Receptor (CAR) redirected autologous T-cells in patients with high risk, relapsed CD19+ and CD20+ haematological malignancies.

Related Conditions:
  • B-Cell Acute Lymphoblastic Leukemia
  • B-Cell Non-Hodgkin Lymphoma
  • Chronic Lymphocytic Leukemia
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Immunotherapy With Bispecific CAR-T Cells for B-Cell Lymphoma, ALL and CLL
  • Official Title: Phase I Study of T Cells Expressing an Anti-CD19 and Anti-CD20 Bispecific Chimeric Receptor in Patients With B Cell Malignancies

Clinical Trial IDs

  • ORG STUDY ID: Doing-006
  • NCT ID: NCT03271515

Conditions

  • Leukemia
  • Lymphoma

Interventions

DrugSynonymsArms
anti-CD19 anti-CD20 Bispecific CAR-Tanti-CD19 anti-CD20 Bispecific CAR-T

Purpose

This study aims to evaluate the safety, efficacy and duration of response of anti-CD19 anti-CD20 Bispecific Chimeric Antigen Receptor (CAR) redirected autologous T-cells in patients with high risk, relapsed CD19+ and CD20+ haematological malignancies.

Detailed Description

      This is a multi-centre, non-randomised, open label Phase I clinical trial of an Advanced
      Therapy Investigational Medicinal Product named CD19 CD20 Chimeric Antigen Receptor (CAR)
      T-cells (CD19 CAR T-cells) in patients with high risk, relapsed CD19+ and CD20+haematological
      malignancies (Leukemia and lymphoma). Following informed consent and registration to the
      trial, patients will undergo an unstimulated leukapheresis for the generation of the CD19
      CD20 CAR T-cells. Patients will receive the CD19 CD20 CAR T-cells following lymphodepleting
      chemotherapy. The study will evaluate the safety, efficacy and duration of response of the
      CD19 CD20 CAR T-cells in patients with high risk relapsed CD19+ malignancies.
    

Trial Arms

NameTypeDescriptionInterventions
conventional therapyNo Interventionpatients accept conventional radioactive and chemical therapy.
    anti-CD19 anti-CD20 Bispecific CAR-TExperimentalpatients accept transfusion of anti-CD19 anti-CD20 Bispecific CAR-T cells.
    • anti-CD19 anti-CD20 Bispecific CAR-T

    Eligibility Criteria

            Inclusion Criteria:
    
              1. Relapsed or refractory B cell derived acute lymphoblastic leukemia(ALL), chronic
                 lymphoblastic leukemia(CLL) and non-hodgkin lymphoma.
    
              2. KPS>60.
    
              3. Life expectancy>3 months.
    
              4. Gender unlimited, age from 18 years to 70 years.
    
              5. CD19 or CD20 expression must be detected on greater than 15% of the malignant cells by
                 immunohistochemistry or greater than 30% by flow cytometry.
    
              6. Patients who have failed at least one line of a standard treatment.
    
              7. No serious mental disorder.
    
              8. Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate
                 pulmonary function as indicated by room air oxygen saturation of >94%, and adequate
                 renal function(Cr≤133umol/L).
    
              9. No other serious diseases(autoimmune disease, immunodeficiency etc.).
    
             10. No other tumors.
    
             11. Patients volunteer to participate in the research.
    
             12. Patients with history of allogeneic stem cell transplantation are eligible if at least
                 100 days post-transplant, if there is no evidence of active GVHD and no longer taking
                 immunosuppressive agents for at least 30 days prior to
    
            Exclusion Criteria:
    
              1. KPS<50.
    
              2. Patients are allergic to cytokines.
    
              3. Central nervous system leukemia within 28 days.
    
              4. Uncontrolled active infection.
    
              5. Acute or chronic GVHD.
    
              6. Treated with T cell inhibitor.
    
              7. Pregnancy and nursing females.
    
              8. HIV/HBV/HCV Infection.
    
              9. Other situations we think improper for the research.
          
    Maximum Eligible Age:70 Years
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Antitumor Effects
    Time Frame:Every 3 months post treatment up to 24 months
    Safety Issue:
    Description:Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.

    Secondary Outcome Measures

    Measure:Survival time of Anti-CD19 Anti-CD20 CAR T cells in vivo.
    Time Frame:3 years
    Safety Issue:
    Description:To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood.
    Measure:Adverse events of each patient.
    Time Frame:3 years
    Safety Issue:
    Description:Determine the toxicity profile of the CD19 CD20 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.

    Details

    Phase:Phase 1
    Primary Purpose:Interventional
    Overall Status:Not yet recruiting
    Lead Sponsor:Beijing Doing Biomedical Co., Ltd.

    Trial Keywords

    • leukemia
    • lymphoma
    • CAR-T
    • bispecific
    • CD20
    • CD19

    Last Updated