Actively Recruiting
Allogeneic UCB-derived, Dual-targeting BCMA/CD19 CAR-T for Relapsed/Refractory Multiple Myeloma
Led by Xi'an No.3 Hospital · Updated on 2025-11-25
18
Participants Needed
1
Research Sites
221 weeks
Total Duration
On this page
Sponsors
X
Xi'an No.3 Hospital
Lead Sponsor
U
Ucello Therapeutics Co., Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Allogeneic UCB-derived, Dual-targeting BCMA/CD19 CAR-T for Relapsed/Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years, any gender
- Diagnosed with multiple myeloma based on Chinese guidelines, including bone marrow plasma cells ≥10% and specific SLiM CRAB features
- Relapsed or refractory multiple myeloma with at least three prior therapies including proteasome inhibitor, immunomodulatory agent, or anti-CD38 antibody
- Presence of at least one measurable lesion with specific protein or biopsy criteria
- Negative for Donor Specific Antibody (DSA)
- Adequate organ function including creatinine clearance ≥60 mL/min, liver enzymes ≤3× upper limit of normal, and bilirubin ≤1.5× upper limit (or ≤2.5× for Gilbert's syndrome)
- Women of childbearing potential must have a negative pregnancy test within 7 days before enrollment and agree to use effective contraception
- Written informed consent obtained before any study procedures
You will not qualify if you...
- Lactating women
- Unwillingness to undergo 15 years of follow-up
- Poor compliance with study procedures
- Under legal guardianship or conservatorship
- History of Grade 4 or higher CRS or neurotoxicity from previous CAR-T therapy
- Within 5 half-lives of prior anti-myeloma therapies before enrollment
- Disease progression after debulking therapy
- Active or severe central nervous system abnormalities or irreversible severe CNS toxicity from prior treatments
- Radiotherapy or radioimmunotherapy within 8 weeks before enrollment
- Hematopoietic stem cell transplantation within 3 months or donor lymphocyte infusion within 6 weeks before screening
- Active graft-versus-host disease requiring systemic therapy within 4 weeks before CAR-T infusion
- Autoimmune diseases requiring systemic immunosuppressive therapy
- High-dose systemic corticosteroids within 4 weeks before lymphodepletion
- Known hypersensitivity to UCAR-T or its components
- Uncontrolled cardiovascular or pulmonary diseases within 6 months before enrollment
- History of hypertensive crisis or encephalopathy within 3 months before screening
- Active infections not controlled by treatment or positive blood cultures within 7 days before enrollment
- Major surgery within 3 months before screening
- Live-attenuated vaccine within 4 weeks before screening
- Any medical or lab findings that may jeopardize patient safety
- Planned medical or surgical treatments that interfere with the study
- Another malignancy within 2 years before screening (except certain skin or cervical cancers)
- Psychiatric conditions preventing study understanding or cooperation
- Positive for hepatitis B, hepatitis C, HIV, HTLV, syphilis, or CMV infection
- Contraindications to lymphodepleting agents or drugs used to manage adverse events such as tocilizumab
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Xi'an No.3 Hospital
Xi’an, Shanxi, China, 710016
Actively Recruiting
Research Team
X
Xiequn Chen, M.D.
CONTACT
Q
Qiang Zou, Ph.D. & M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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