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

Study Overview
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Brief Summary
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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.

Detailed Description
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In this study, about 10 patients with relapsed or refractory multiple myeloma aged ≥60 years were recruited for IM21 CAR-T cell single transfusion therapy. The safety and tolerability of the treatment were evaluated, and the curative effect was initially observed. The research plan includes five stages: screening stage, cell collection stage, chemotherapy pretreatment stage, infusion stage and follow-up stage.

Official Title
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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

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: IM21 CAR-T cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with relapsed or refractory multiple myeloma who had received at least second line regular treatment failure; Age ≥60 years old; The expected survival time is more than 3 months; ECOG score is 0-2; Those who voluntarily participate in the study and sign the informed consent; Hemoglobin (Hb)≥80g/L; Absolute count of neutrophils (ANC) >1×10^9/L Total platelet count (PLT)≥35×10^9/L; left ventricular ejection fraction > 45%. Exclusion Criteria: High-risk viscera-involved patients: the tumor invaded the gastrointestinal tract, lung, pericardium and one of the great vessels; Those who have graft versus host disease and need to use immunosuppressive agents; Use of systemic steroids in combination within 5 days prior to the blood collection period (except for recent or current use of inhaled steroids); Active hepatitis B or C virus, HIV or other untreated active infected persons; Any circumstance that, in the opinion of the investigator, may increase the risk to the subject or interfere with test results; Patients who use chemotherapy or radiotherapy within 3 days before the blood collection stage.

Ages Eligible for Study
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Minimum Age: 60 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>IM21 CAR-T cells administrated in a dosage to be selected by physician from a specific range. | Drug: IM21 CAR-T cells<br>* IM21 CAR-T cells Drug: Fludarabine Two days before cell infusion, all patients will be treated with fludarabine for 3 days Drug: Cyclophosphamide Two days before cell infusion, all patients will be treated with Cyclophosphamide for 3 days Other Names: Fludarabine Cyclophosphamide<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events within 1 month after CAR-T cell infusion | The primary endpoint wasIncidence of adverse events within 1 month after CAR-T cell infusion | 30days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate(ORR) at 90 days |  | 90days | 

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