Clinical Study to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in the Treatment of Elderly Patients With Relapsed or Refractory Multiple Myeloma

• Status: Recruiting
• Trial end date: 2023-03-02
• Target enrollment: 0
• Participant gender: All

Summary

This is a single center study to assess the efficacy and safety of IM21 CAR-T cells in adult with R/R multiple myeloma in China.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd.

Criteria

Inclusion Criteria:

1. Patients with relapsed or refractory multiple myeloma who had received at least second line regular treatment failure;

2. Age ≥60 years old;

3. The expected survival time is more than 3 months;

4. ECOG score is 0-2;

5. Those who voluntarily participate in the study and sign the informed consent;

6. Hemoglobin (Hb)≥80g/L; Absolute count of neutrophils (ANC) >1×10^9/L Total platelet count (PLT)≥35×10^9/L;

7. left ventricular ejection fraction > 45%.

Exclusion Criteria:

1. High-risk viscera-involved patients: the tumor invaded the gastrointestinal tract, lung, pericardium and one of the great vessels;

2. Those who have graft versus host disease and need to use immunosuppressive agents;

3. Use of systemic steroids in combination within 5 days prior to the blood collection period (except for recent or current use of inhaled steroids);

4. Active hepatitis B or C virus, HIV or other untreated active infected persons;

5. Any circumstance that, in the opinion of the investigator, may increase the risk to the subject or interfere with test results;

6. Patients who use chemotherapy or radiotherapy within 3 days before the blood collection stage.