Clinical trial NCT05478343: Clinical Trial to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in Patients With Relapsed and Refractory (R/R) Multiple Myeloma
Official title: Clinical Trial to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in Patients With Relapsed and Refractory (R/R) Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Lead sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-07-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Up to 28 days after CAR-T cell infusion
measure: Persistence of CAR-T cells (cell counts and cell percentage in peripheral blood and bone marrow )
timeFrame: Up to 24 weeks after CAR-T cell infusion
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: Up to 24 weeks after CAR-T cell infusion
measure: Overall survival (OS)
timeFrame: Up to 24 weeks after CAR-T cell infusion
measure: Minimal residual disease（MRD）
timeFrame: Up to 24 weeks after CAR-T cell infusion
measure: Duration of Response (DOR)
timeFrame: Up to 24 weeks after CAR-T cell infusion
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Hospital of China Medical University
state: Liaoning
Study officials:
affiliation: First Hospital of China Medical University
name: Xiaojing Yan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: