Clinical trial · Interventional
LCAR-M61S and LCAR-M61D in Treatment of Relapsed/Refractory Multiple Myeloma
A Clinical Study to Evaluate the Safety, Tolerance and Efficacy of LCAR-M61S and LCAR-M61D Cell Preparations in Patients With Relapsed/Refractory Multiple Myeloma
NCT06472479CI-TRIAL-00078373not yet recruitingN/AClinicalTrials.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)
A prospective, two-cohort, open-label dose-exploration and expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor efficacy characteristics of LCAR-M61S and LCAR-M61D in patients with relapsed/refractory multiple myeloma.
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 |
|---|---|---|---|
| Relapsed/Refractory Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LCAR-M61D cells preparation | Biological | — | UNRESOLVED |
| LCAR-M61S cells preparation | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LCAR-M61S and LCAR-M61D
- description
- Each subject will be given a single-dose LCAR-M61S or LCAR-M61D cells infusion at each dose level.
- interventionNames
- Biological: LCAR-M61S cells preparation
- Biological: LCAR-M61D cells preparation
Primary outcomes (7)
- measure
- Dose-limiting toxicity (DLT) rate
- timeFrame
- From LCAR-M61S and LCAR-M61D cell preparations infusion (Day 1) until the 30th day of follow-up period, assessed up to 30 days
- description
- DLT was classified according to the NCI-CTCAE V5.0 toxicity evaluation criteria and ASTCT consensus classification within 30 days after dose infusion (D1-D30), which was considered by the investigator or collaborator to be reasonably related to LCAR-M61S or LCAR-M61D cell therapy.
- measure
- Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects voluntarily participate in clinical research; * Age ≥18 years old; * Eastern Cooperative Oncology Group (ECOG) score 0-2; * Examination evidence of initial diagnosis of MM according to IMWG diagnostic criteria; * Measurable lesions were present; * Subjects have received at least three previous lines of multiple myeloma therapy, each with at least one complete therapy cycle, unless the best response to the therapeutic regimen was documented as disease progression (PD confirmed according to IMWG criteria); * Expected survival ≥3 months; * Clinical laboratory values in the screening period meet criteria; Exclusion Criteria: * Received previous therapy targeting GPRC5D and/or CD19 targets; * Prior antineoplastic therapy and meet exclusion criteria (before apheresis); * Subjects had Waldenstrom macroglobulinemia, POEMS syndrome, or primary AL amyloidosis at the time of screening. * Subjects who were positive for any of HBsAg, HBV DNA, HCV-Ab, HCV RNA, and HIV-Ab; * Life-threatening allergic reactions, hypersensitivity reactions, or intolerance to CAR-T cell formulations or their excipients, including DMSO, are known. * Serious underlying diseases were present; * Female subjects who were pregnant, breastfeeding, or planning to become pregnant while participating in this study or within 1 year of receiving study treatment. * Also enrolled in other clinical studies.
References
Publications (0)
Data not yet available
No reference posted for this study.