Clinical Trials /

Study of BCMA CAR-T in Multiple Myeloma

NCT03559764

Description:

This is a single centre、single arm、open-label,to investigate the safety and efficacy of anti-BCMA CAR T cells in patients with Relapsed and Refractory multiple myeloma.

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Not yet recruiting

Phase:

Early Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of BCMA CAR-T in Multiple Myeloma
  • Official Title: Clinical Study on the Safety and Efficacy of Anti-BCMA CAR T Cells With Relapsed and Refractory Multiple Myeloma

Clinical Trial IDs

  • ORG STUDY ID: BCMA CAR T-HNRM-01
  • NCT ID: NCT03559764

Conditions

  • Relapsed and Refractory Multiple Myeloma

Interventions

DrugSynonymsArms
Anti-BCMA CAR T cellsAnti-BCMA CAR T cells

Purpose

This is a single centre、single arm、open-label,to investigate the safety and efficacy of anti-BCMA CAR T cells in patients with Relapsed and Refractory multiple myeloma.

Detailed Description

      Multiple myeloma(MM) is one of the most common malignant diseases in the blood system.There
      is still no cure for the disease which only control the development of the disease in various
      ways.CAR - T cells was taken in the form of genetic modification, and specific identified
      target antigen monoclonal antibody of single variable region (scFv) expression in T cell
      surface, and coupled with the activation of intracellular proliferation signal domain. The
      study will follow a 3 + 3 design of dose-escalating cohorts. After a patient
      enrolls,leukapheresis will be performed to obtain peripheral blood mononuclear cells which
      will be sent to a manufacturing site to produce anti- BCMA CAR T cells. The cells will then
      be returned to the investigational site and, after a standard chemotherapy based conditioning
      regimen, will be administered to the patient. Treated patients will undergo serial
      measurements of safety, tolerability and response.

      In order to lay a foundation for the application of relapsed/refractory multiple myeloma
      patients with CAR-T therapy,objects are refractory/ relapsed patients with multiple
      myeloma,and plans to into the group of the number of cases in 20 cases.
    

Trial Arms

NameTypeDescriptionInterventions
Anti-BCMA CAR T cellsExperimentalTotal dose of 0.5-6 millions /kg cells will be administered at day -2, day -1 and day 0 by split dose (30%, 30% and 40% respectively).
  • Anti-BCMA CAR T cells

Eligibility Criteria

        Inclusion Criteria:

          1. Male or female, 18 to 70 years old (including 18 and 70 years old)

          2. BCMA antigen diagnosed by pathology and histological examination was positive

          3. ECOG ≤2,and the excepted survival ≥ 3 months

          4. Patients with BCMA+ myeloma who received ≥ 1 line of chemoradiotherapy or tumor
             relapsed

          5. The main organs function is good; (1) liver function: ALT/AST<3 times normal value
             upper limit (ULN) and total bilirubin <34.2 (mol/L); (2) renal function: creatinine
             <220 mu /L,GFR > 30mL/min; (3) lung function: blood oxygen saturation is greater than
             95%; (4) cardiac function: left ventricular ejection fraction (LVEF) is greater than
             50%;

          6. Platelets > 40 billion/L;

          7. Patients without any anti-cancer treatment such as chemotherapyradiotherapy,
             immunotherapy( immunosuppressive drugs )within 2-4 weeks before, and the
             treatment-related toxicity reaction ≤1 level prior to enrollment(except low toxicity
             lose hair for example)

          8. Venous channel is unobstructed, which can meet the needs of intravenous drip;

          9. Voluntary informed consent is given, agree to follow the trial treatment and visit
             plan.

        Exclusion Criteria:

          1. Patients with allergy to large molecules such as antibodies or cytokines;

          2. More than 5mg of hormones (except patients with inhaled hormone) were used within 2 to
             4 weeks prior enrollment;

          3. Patients with severe autoimmune diseases or immunodeficiency diseases;

          4. Patients treated with other immune cellular products (DC, CIK, T, NK, and CART
             products with CD19 or other targets);

          5. Patients with uncontrollable infectious disease in the first 4 weeks of treatment;

          6. Active hepatitis B DNA > 1000copy/mL/ , hepatitis C positive, (HCV positive
             resistance, HCV RNA positive);

          7. Patients participated in other clinical trials within 6 weeks prior enrollment;

          8. Patients with mental illness;

          9. Patients with drug abuse/addiction and medical, psychological or social conditions may
             interfere with the study or evaluate the results of the study;

         10. Patients have alcohol dependence;

         11. Pregnant or lactating women; Men or women who have a pregnancy plan within a year; The
             patients cannot guarantee effective contraceptive measures during the trial period;

         12. Patients had other conditions that were not appropriate for the group determined by
             the researchers.
      
Maximum Eligible Age:70 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:The safety of CAR T is evaluated to determine if CRS occurred
Time Frame:Day 3-Year 2 after injection
Safety Issue:
Description:defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment

Details

Phase:Early Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Allife Medical Science and Technology Co., Ltd.

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