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

NCT ID: NCT04537442

Last Updated: 2020-09-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-03
• Study Completion Date: 2023-03-02

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IM21 CAR-T cells

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

Group Type: EXPERIMENTAL

IM21 CAR-T cells

Intervention Type: DRUG

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

Interventions

IM21 CAR-T cells

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Immunochina Medical Science & Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hui Liu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Beijing Hospital

Locations

Beijing hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Fei Wu, MD

Role: CONTACT

wufei@immunochina.com

+8615801390058

Facility Contacts

Hui Liu, MD, PhD

Role: primary

liuhui8140@126.com

13520618812

References

Wang T, Yang Y, Ma L, Feng R, Li J, Zhang C, Bai J, Ding Y, Liu G, Wu F, Lu X, Feng S, Li Z, He T, Li J, Liu H. BCMA-BBZ-OX40 CAR-T Therapy Using an Instant Manufacturing Platform in Multiple Myeloma. J Immunother Cancer. 2024 Sep 23;12(9):e009476. doi: 10.1136/jitc-2024-009476.

Reference Type: DERIVED

PMID: 39313307 (View on PubMed)

Wang T, He T, Ma L, Yang Y, Feng R, Ding Y, Shan Y, Bu B, Qi F, Wu F, Lu XA, Liu H. Clinical Outcomes of BCMA CAR-T Cells in a Multiple Myeloma Patient With Central Nervous System Invasion. Front Oncol. 2022 May 16;12:854448. doi: 10.3389/fonc.2022.854448. eCollection 2022.

Reference Type: DERIVED

PMID: 35651792 (View on PubMed)

Other Identifiers

Immunochina

Identifier Type: -

Identifier Source: org_study_id