Multiple Myeloma
Conditions
Keywords
Multiple Myeloma
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.
Interventions
BIOLOGICALIM21 CAR-T cells
IM21 CAR-T cells administrated in a dosage to be selected by physician from a specific range.
Sponsors
Beijing Immunochina Medical Science & Technology Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events (AEs) | 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 ) | 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
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) | Up to 24 weeks after CAR-T cell infusion |
| Overall survival (OS) | 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 |
Countries
China
Contacts
Primary ContactFei Wu
Outcome results
None listed