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

Phase 1

• Conditions: Multiple Myeloma
• Interventions: Drug: IM21 CAR-T cells

• Registration Number: NCT04537442
• Lead Sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd.

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-28
• Study First Submitted QC: 2020-08-28
• Last Update Submitted: 2020-08-28
• Study Start: 2020-09-03
• Study First Posted: 2020-09-03
• Last Update Posted: 2020-09-03
• Primary Completion: 2022-12-30
• Study Completion: 2023-03-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events within 1 month after CAR-T cell infusion	30days	The primary endpoint wasIncidence of adverse events within 1 month after CAR-T cell infusion

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate(ORR) at 90 days	90days

Trial Locations

Locations (1)

Beijing hospital; 🇨🇳 Beijing, Beijing, China