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

NCT ID: NCT05478343

Last Updated: 2022-07-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-06
• Study Completion Date: 2023-08-01

Brief Summary

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

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

Group Type: EXPERIMENTAL

IM21 CAR-T cells

Intervention Type: BIOLOGICAL

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

Interventions

IM21 CAR-T cells

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 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

Xiaojing Yan, M.D.

Role: PRINCIPAL_INVESTIGATOR

First Hospital of China Medical University

Locations

Hospital of China Medical University

Shenyang, Liaoning, China

Site Status: RECRUITING

Countries

China

Central Contacts

Fei Wu

Role: CONTACT

wufei@imunopharm.com

+8615801390058

Facility Contacts

Xiaojing Yan, M.D.

Role: primary

References

Zhou L, Fu W, Wu S, Xu K, Qiu L, Xu Y, Yan X, Zhang Q, Zhang M, Wang L, Hong R, Chang AH, Yu J, Fu S, Kong D, Li L, Wang Y, Li Z, Jiang H, Huang J, Liu Z, Su N, Wei G, Hu Y, Huang H. Derivation and validation of a novel score for early prediction of severe CRS after CAR-T therapy in haematological malignancy patients: A multi-centre study. Br J Haematol. 2023 Aug;202(3):517-524. doi: 10.1111/bjh.18873. Epub 2023 May 16.

Reference Type: DERIVED

PMID: 37192741 (View on PubMed)

Other Identifiers

YMCART201909

Identifier Type: -

Identifier Source: org_study_id