Clinical Trial to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in Patients With Relapsed and Refractory (R/R) Multiple Myeloma

Study Overview
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Brief Summary
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This is a open-label to determine the efficacy and safety of IM21 CAR-T cells in adult with R/R multiple myeloma.

Official Title
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Clinical Trial to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in Patients With Relapsed and Refractory (R/R) Multiple Myeloma

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Biological: IM21 CAR-T cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of MM with relapsed or refractory disease and have had at least 3 different prior lines of therapy including proteasome inhibitor . Evidence of cell membrane BCMA expression. Subjects must have measurable disease,including 1) Serum M-protein greater or equal to10 g/L. 2) Urine M-protein greater or equal to 200 mg/24 h. 3)Serum free light chain (FLC) assay: involved FLC level greater or equal to 100 mg/L provided serum FLC ratio is abnormal. ≥ 18 years of age at the time of signing informed consent. Estimated life expectancy >3 months. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Women of childbearing age who had a negative blood pregnancy test before the start of the trial and agreed to take effective contraceptive measures during the trial period until the last follow-up; male subjects with fertility partners agreed to take effective contraceptive measures during the trial period until the last follow-up. Adequate organ function. Voluntarily sign informed consent form(s). Exclusion Criteria: Subjects with graft versus host disease and need to use immunosuppressive agents. Subjects who had received chemotherapy or radiotherapy within 3 days prior to the blood collection period. Use of systemic steroids in combination within 5 days prior to the blood collection period (except for recent or current use of inhaled steroids) Subjects who had previously used any gene therapy product. Subjects with known central nervous system disease. Subjects with plasmacytic leukemia, Wallenian macroglobulinemia, POEMS syndrome, or primary light-chain amyloidosis. Subjects had the following cardiac conditions, including but not limited to unstable angina pectoris, myocardial infarction or coronary artery bypass graft in the 6 months prior to enrollment, severe arrhythmias with poor drug control; Subjects infected with active HBV or HCV, HIV, syphilis or other untreated active infections; Pregnant or lactating women. Subjects who have other uncontrolled diseases and are considered by the researchers to be unsuitable to participate in the study. Any situation that the researcher believes may increase the risk of subjects or interfere with the results of clinical trials.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IM21 CAR-T cells<br> | Biological: IM21 CAR-T cells<br>* IM21 CAR-T cells administrated in a dosage to be selected by physician from a specific range.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) | Incidence of treatment related AEs | Up to 28 days after CAR-T cell infusion | 
| Persistence of CAR-T cells (cell counts and cell percentage in peripheral blood and bone marrow ) | The persistence over time of CAR T cells in the peripheral blood as determined by flow cytometry and qPCR. | Up to 24 weeks after CAR-T cell infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) |  | Up to 24 weeks after CAR-T cell infusion | 
| Overall survival (OS) |  | Up to 24 weeks after CAR-T cell infusion | 
| Minimal residual disease（MRD） |  | Up to 24 weeks after CAR-T cell infusion | 
| Duration of Response (DOR) |  | Up to 24 weeks after CAR-T cell infusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Myeloma