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

Beijing Immunochina Medical Science & Technology

Status and phase: Unknown; Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: IM21 CAR-T cells

Study type: Interventional

Funder types: Industry

Identifiers

NCT04537442

Immunochina

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

IM21 CAR-T cells

Experimental group

Description:

IM21 CAR-T cells administrated in a dosage to be selected by physician from a specific range.

Treatment:

Drug: IM21 CAR-T cells