NCT05478343
Unknown
Early Phase 1
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 Co., Ltd.1 site in 1 country10 target enrollmentStarted: May 6, 2021Last updated:
ConditionsMultiple Myeloma
Overview
- Phase
- Early Phase 1
- Sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Incidence of adverse events (AEs)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Outcomes
Primary Outcomes
Incidence of adverse events (AEs)
Time Frame: Up to 28 days after CAR-T cell infusion
Incidence of treatment related AEs
Persistence of CAR-T cells (cell counts and cell percentage in peripheral blood and bone marrow )
Time Frame: Up to 24 weeks after CAR-T cell infusion
The persistence over time of CAR T cells in the peripheral blood as determined by flow cytometry and qPCR.
Secondary Outcomes
- Overall survival (OS)(Up to 24 weeks after CAR-T cell infusion)
- Objective response rate (ORR)(Up to 24 weeks after CAR-T cell infusion)
- Minimal residual disease（MRD）(Up to 24 weeks after CAR-T cell infusion)
- Duration of Response (DOR)(Up to 24 weeks after CAR-T cell infusion)
Investigators
Study Sites (1)
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