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

Beijing Immunochina Medical Science & Technology

Status and phase

Enrolling

Early Phase 1

Conditions

Multiple Myeloma

Treatments

Biological: IM21 CAR-T cells

Study type

Interventional

Funder types

Industry

Identifiers

YMCART201909

Details and patient eligibility

About

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

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.