Multiple Myeloma
Conditions
Keywords
Multiple myeloma
Brief summary
This is a single center study to assess the efficacy and safety of IM21 CAR-T cells in adult with R/R multiple myeloma in China.
Detailed description
In this study, about 10 patients with relapsed or refractory multiple myeloma aged ≥60 years were recruited for IM21 CAR-T cell single transfusion therapy. The safety and tolerability of the treatment were evaluated, and the curative effect was initially observed. The research plan includes five stages: screening stage, cell collection stage, chemotherapy pretreatment stage, infusion stage and follow-up stage.
Interventions
DRUGIM21 CAR-T cells
IM21 CAR-T cells Drug: Fludarabine Two days before cell infusion, all patients will be treated with fludarabine for 3 days Drug: Cyclophosphamide Two days before cell infusion, all patients will be treated with Cyclophosphamide for 3 days Other Names: Fludarabine Cyclophosphamide
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
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with relapsed or refractory multiple myeloma who had received at least second line regular treatment failure; 2. Age ≥60 years old; 3. The expected survival time is more than 3 months; 4. ECOG score is 0-2; 5. Those who voluntarily participate in the study and sign the informed consent; 6. Hemoglobin (Hb)≥80g/L; Absolute count of neutrophils (ANC) \>1×10\^9/L Total platelet count (PLT)≥35×10\^9/L; 7. left ventricular ejection fraction \> 45%.
Exclusion criteria
1. High-risk viscera-involved patients: the tumor invaded the gastrointestinal tract, lung, pericardium and one of the great vessels; 2. Those who have graft versus host disease and need to use immunosuppressive agents; 3. Use of systemic steroids in combination within 5 days prior to the blood collection period (except for recent or current use of inhaled steroids); 4. Active hepatitis B or C virus, HIV or other untreated active infected persons; 5. Any circumstance that, in the opinion of the investigator, may increase the risk to the subject or interfere with test results; 6. Patients who use chemotherapy or radiotherapy within 3 days before the blood collection stage.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events within 1 month after CAR-T cell infusion | 30days | The primary endpoint wasIncidence of adverse events within 1 month after CAR-T cell infusion |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate(ORR) at 90 days | 90days |
Countries
China
Contacts
Primary ContactFei Wu, MD
Outcome results
None listed