Clinical Trials /

Anti-CD19/BCMA Bispecific CAR-T Cell Therapy for R/R MM

NCT03706547

Description:

The goal of this clinical trial is to study the feasibility and efficacy of anti-CD19/BCMA bispecific chimeric antigen receptors (CARs) T cell therapy for relapsed and refractory multiple myeloma.

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Anti-CD19/BCMA Bispecific CAR-T Cell Therapy for R/R MM
  • Official Title: Clinical Study of Anti-CD19/BCMA Bispecific Chimeric Antigen Receptors (CARs) T Cell Therapy for Relapsed and Refractory Multiple Myeloma

Clinical Trial IDs

  • ORG STUDY ID: SHZS-MM002
  • NCT ID: NCT03706547

Conditions

  • Multiple Myeloma in Relapse
  • Multiple Myeloma Progression

Interventions

DrugSynonymsArms
anti-CD19/BCMA CAR-T cellsanti-CD19/BCMA CAR-T cells
Fludarabineanti-CD19/BCMA CAR-T cells
Cyclophosphamideanti-CD19/BCMA CAR-T cells

Purpose

The goal of this clinical trial is to study the feasibility and efficacy of anti-CD19/BCMA bispecific chimeric antigen receptors (CARs) T cell therapy for relapsed and refractory multiple myeloma.

Detailed Description

      Primary Objectives

      1. To determine the feasibility ad safety of anti-CD19/BCMA CAR-T cells in treating patients
      with BCMA-positive multiple myeloma.

      Secondary Objectives

        1. To access the efficacy of anti-CD19/BCMA CAR-T cells in patients with multiple myeloma.

        2. To determine in vivo dynamics and persistency of anti-CD19/BCMA CAR-T cells.
    

Trial Arms

NameTypeDescriptionInterventions
anti-CD19/BCMA CAR-T cellsExperimentalChemotherapy with a classic combination with fludarabine and cyclophosphamide; Administration with anti-CD19/BCMA CAR-T cells in the BCMA-positive multiple myeloma patients.
  • Fludarabine
  • Cyclophosphamide

Eligibility Criteria

        Inclusion Criteria:

          -  Expected survival > 12 weeks

          -  Diagnosis of Multiple Myeloma by IMWG updated criteria (2014)

          -  Pathology demonstrated that BCMA-poitive malignant plasma cells exited in bone marrow
             or plamacytoma

          -  Exited measurable lesions and in accordance with one of the following test indicators:
             serum M protein≥1 g/dl; urine M protein≥200 mg/24h; serum free light chain≥10 mg/dl;
             diagnosis of plasmacytoma by biopsy

          -  The criteria for relapsed and refractory multiple myeloma: patients previously
             received at least 3 different prior treatment regimens for multiple myeloma, including
             protein inhibitors (eg: Bortezomib), and immunomodulator (eg: Revlimid), and have
             disease progression in the past 60 days

          -  At least 90 days after stem cell transplantation

          -  Clinical performance status of ECOG score 0-2

          -  Creatinine≤2.0 mg/dl

          -  Bilirubin≤2.0 mg/dl

          -  The ALT/AST value is lower than 2.5-fold of normal value

          -  Accessible to intravenous injection, and no white blood cell collection
             contraindications

          -  Sexually active patients must be willing to utilize one of the more effective birth
             control methods for 30 days after the CTL infusion. Male partner should use a condom

          -  5mg/day dose of Prednisone or other equivalent steroid hormone drugs (eg:
             Dexamethasone) were not used for two weeks before apheresis and CAR-T infusion

          -  Able to understand and sign the Informed Consent Document.

        Exclusion Criteria:

          -  Patients with symptoms of central nervous system

          -  Patients with second malignancies in addition to multiple myeloma

          -  Active hepatitis B or C, HIV infections

          -  Any other active diseases could affect the enrollment of this trial

          -  Long term use of immunosuppressive agents after organ transplantation, except
             currently receiving or recently received glucocorticoid treatment

          -  Patients with organ failure

          -  Women of child-bearing potential who are pregnant or breastfeeding during therapy, or
             have a planned pregnancy with 2 months after therapy

          -  A history of mental illness and poorly controlled

          -  Women of child-bearing potential who are not willing to practice birth control from
             the time of enrollment on this study and for 2 months after receiving the preparative
             regimen. Women of child bearing potential must have a negative serum or urine
             pregnancy test performed within 48 hours before infusion

          -  Patients who are accounted by researchers to be not appropriate for this test

          -  Subjects suffering disease affects the understanding of informed consent or complying
             with study protocol
      
Maximum Eligible Age:70 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
Time Frame:6 months
Safety Issue:
Description:Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0

Secondary Outcome Measures

Measure:Overall remission rate defined by the standard response criteria for myeloma for each arm
Time Frame:8 weeks
Safety Issue:
Description:Overall remission rate defined by the standard response criteria for myeloma for each arm
Measure:Duration of CAR-positive T cells in circulation
Time Frame:6 months
Safety Issue:
Description:Duration of CAR-positive T cells in circulation

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Peng Liu

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