OncoMatch/Clinical Trials/NCT07139509
Allogeneic UCB-derived, Dual-targeting BCMA/CD19 CAR-T for Relapsed/Refractory Multiple Myeloma
Is NCT07139509 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies allogeneic cord blood-derived, dual-targeting CD19/BCMA CAR-T cells for relapsed/refractory multiple myeloma(mm).
Treatment: allogeneic cord blood-derived, dual-targeting CD19/BCMA CAR-T cells — The purpose of this clinical trial is to learn if allogeneic cord blood-derived CAR-T cell drug works to treat Multiple Myeloma (MM) including Bone-related extramedullary (EMB) disease and extramedullary extraosseous disease(EME) in adults. It will also learn about the safety of the allogeneic cord blood-derived CAR-T cell drug. The main questions it aims to answer are: 1. What adverse events occur and the incidence rate of DLTs within 28 days and UCAR-T-related AEs within 28 days after the allogeneic cord blood-derived CAR-T cell injection for multiple myeloma (MM)? 2. Which dose level is the optimal biological dose (OBD)? 3. What is the overall responserate (ORR), including stringent complete response (sCR), completeresponse (CR),very good partial response (VGPR), partial response (PR), minimal Response (MR) and DOR, PFS, RFS, OS? Participants will: 1. be pretreated with FC regimen, fludarabine (30mg/m²/d, days -5, -4, and -3) and cyclophosphamide (300\~500 mg/m²/d, day -5,-4, and -3). 2. rest for 2 days on Day-2 and Day-1. Tumor burden should be re-evaluated and chemotherapy side effects assessment. 3. receive allogeneic cord blood-derived CAR-T cells infusion 4. Visit the clinic at D28, 1 month, 2 months, 3 months, 4 months, 6 months, 9 months and 1 year after CAR-T cells infusion.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Prior therapy
Must have received: proteasome inhibitor
Must have been treated with a proteasome inhibitor
Must have received: immunomodulatory agent
Must have been treated with an immunomodulatory agent
Must have received: anti-CD38 antibody
Must have been treated with an anti-CD38 antibody
Cannot have received: hematopoietic stem cell transplantation
Exception: within 3 months before screening
Hematopoietic stem cell transplantation (HSCT) within 3 months before screening
Cannot have received: autologous stem cell transplantation
Exception: within 100 days
patients who have undergone autologous stem cell transplantation within 100 days
Cannot have received: solid organ transplantation
patients who have undergone solid organ transplantation
Cannot have received: radioimmunotherapy or radiotherapy
Exception: within 8 weeks before enrollment
Radioimmunotherapy or radiotherapy within 8 weeks before enrollment
Cannot have received: donor lymphocyte infusion
Exception: within 6 weeks before screening
donor lymphocyte infusion within 6 weeks before screening
Cannot have received: anti-multiple myeloma therapies (including approved therapies and other investigational drugs)
Exception: within 5 half-lives before enrollment
Within 5 half-lives of prior anti-MM therapies (including approved therapies and other investigational drugs) before enrollment
Lab requirements
Kidney function
Creatinine clearance rate ≥60 mL/min (Cockcroft-Gault formula)
Liver function
ALT and AST ≤3×ULN; total bilirubin ≤1.5×ULN (≤2.5×ULN for Gilbert's syndrome)
Cardiac function
No uncontrolled cardiovascular disease within 6 months before enrollment, no ≥Grade 2 ventricular or atrial arrhythmias, ≥Grade 2 bradycardia, myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, poorly controlled hypertension with standard medications. LVEF ≥45% by echocardiogram or MUGA at screening.
The most recent assessment during the screening period indicates sufficient organ function, including renal and hepatic function, defined as: Creatinine clearance rate ≥60 mL/min (Cockcroft-Gault formula); ALT and AST ≤3×ULN; total bilirubin ≤1.5×ULN (≤2.5×ULN for Gilbert's syndrome). Cardiac: see exclusion criteria for details.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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