Clinical trial · Interventional
Clinical Study to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in the Treatment of Elderly Patients With Relapsed or Refractory Multiple Myeloma
NCT04537442CI-TRIAL-00046960unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IM21 CAR-T cells | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IM21 CAR-T cells
- description
- IM21 CAR-T cells administrated in a dosage to be selected by physician from a specific range.
- interventionNames
- Drug: IM21 CAR-T cells
Primary outcomes (1)
- measure
- Incidence of adverse events within 1 month after CAR-T cell infusion
- timeFrame
- 30days
- description
- The primary endpoint wasIncidence of adverse events within 1 month after CAR-T cell infusion
Secondary outcomes (1)
- measure
- Objective Response Rate(ORR) at 90 days
- timeFrame
- 90days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDWang T, Yang Y, Ma L, Feng R, Li J, Zhang C, Bai J, Ding Y, Liu G, Wu F, Lu X, Feng S, Li Z, He T, Li J, Liu H. BCMA-BBZ-OX40 CAR-T Therapy Using an Instant Manufacturing Platform in Multiple Myeloma. J Immunother Cancer. 2024 Sep 23;12(9):e009476. doi: 10.1136/jitc-2024-009476. PMID 39313307
- DERIVEDWang T, He T, Ma L, Yang Y, Feng R, Ding Y, Shan Y, Bu B, Qi F, Wu F, Lu XA, Liu H. Clinical Outcomes of BCMA CAR-T Cells in a Multiple Myeloma Patient With Central Nervous System Invasion. Front Oncol. 2022 May 16;12:854448. doi: 10.3389/fonc.2022.854448. eCollection 2022. PMID 35651792