Actively Recruiting
Safety and Efficacy of Metabolically Armed BCMA CAR-T Cells (Meta10-BCMA) in the Treatment of r/r Plasma Cell Neoplasms Clinical Research
Led by Anhui Provincial Hospital · Updated on 2025-07-25
36
Participants Needed
1
Research Sites
120 weeks
Total Duration
On this page
Sponsors
A
Anhui Provincial Hospital
Lead Sponsor
L
Leman Biotech Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
A Study of Metabolically Armed BCMA CAR-T Cells Therapy for Patients With Relapsed and/or Refractory Plasma Cell Neoplasms.
CONDITIONS
Official Title
Safety and Efficacy of Metabolically Armed BCMA CAR-T Cells (Meta10-BCMA) in the Treatment of r/r Plasma Cell Neoplasms Clinical Research
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 19 to 75 years, male or female, with informed consent
- Diagnosed with relapsed or refractory Plasma Cell Neoplasms (Multiple Myeloma, Plasma Cell Leukemia, AL Amyloidosis) per IMWG criteria
- Received at least three prior therapies including proteasome inhibitors and immunomodulatory agents
- Disease progression documented during or within 12 months after last anti-myeloma treatment (no time limit if last treatment was CAR-T)
- Evidence of BCMA protein on tumor cells by immunohistochemistry or flow cytometry
- Unable to receive or relapsed after autologous hematopoietic stem cell transplantation
- ECOG performance status of 0 to 2, except CNS invasion confirmed by investigator
- Estimated life expectancy of at least 12 weeks
- Adequate organ function based on blood counts, liver, kidney, electrolytes, coagulation, and cardiac function tests
- Willing to provide diagnostic evidence and undergo bone marrow exams before and after treatment
- Agree to use effective contraception for 12 months post infusion until two negative CAR-T PCR tests
- Measurable disease by specified laboratory or biopsy criteria including plasma cell levels, monoclonal proteins, or extramedullary lesions
You will not qualify if you...
- Hematopoietic stem cell transplant within 2 months before infusion, or immunosuppressive therapy for graft-versus-host disease during screening
- Major surgery within 4 weeks before screening
- Radiotherapy within 2 weeks before screening
- Intrathecal treatment within 1 week before infusion
- Live vaccination within 4 weeks before infusion or planned after trial participation
- Participation in other clinical trials within 4 weeks before infusion or ongoing participation
- Grade 2 or higher arrhythmia or prolonged QT interval, history of Torsades de pointes or congenital long QT syndrome
- Cardiovascular events within 12 months including unstable angina, myocardial infarction, heart failure, or cerebrovascular events
- Uncontrolled active infections
- HIV infection
- Active hepatitis B or hepatitis C infection
- Severe electrolyte disturbances
- Gastrointestinal bleeding tendencies or recent major bleeding
- History of solid organ transplantation
- Other serious acute, severe, or chronic medical or psychological conditions
- Pregnant or breastfeeding women
- Ongoing treatment with other anti-tumor drugs or QT-prolonging drugs
- Daily oxygen therapy requirement
- Long-term corticosteroid use except local inhalation
- History of psychotropic substance abuse or mental disorders
- Comorbidities that pose significant risk or affect trial completion
- Insufficient mononuclear cells available for CAR-T production
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Anhui Provincial Hospital
Hefei, Anhui, China
Actively Recruiting
Research Team
X
Xingbing Wang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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