Actively Recruiting
Safety and Efficacy of Anti-BCMA/FcRL5 CAR-T Cell Therapy in Treating Relapsed and Refractory Multiple Myeloma (R/R MM)
Led by Xuzhou Medical University · Updated on 2025-01-06
20
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open label, single-arm, Phase 2 study to evaluate the efficacy and safety of Anti-BCMA/FcRL5 CAR-T in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture. Anti-BCMAFcRL5 chimeric antigen receptor (CAR) modified T cells. Prior to Anti-BCMA/FcRL5 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.
CONDITIONS
Official Title
Safety and Efficacy of Anti-BCMA/FcRL5 CAR-T Cell Therapy in Treating Relapsed and Refractory Multiple Myeloma (R/R MM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age is 18 to 70 years old
- Expected survival period of more than 12 weeks
- Multiple myeloma diagnosed by physical, pathological, laboratory, and imaging examinations
- Patients with refractory multiple myeloma
- Patients with multiple myeloma recurrence
- ALT and AST less than 3 times normal levels
- Bilirubin less than 2.0 mg/dl
- Quality of survival score (KPS) greater than 50%
- No serious heart, liver, kidney, or other diseases
- Recurrence or no remission after hematopoietic stem cell transplantation or cellular immunotherapy
- Not suitable for stem cell transplantation or declined transplantation due to conditions
- Ability to provide blood samples intravenously without contraindications to leukapheresis
- Understand and voluntarily sign written informed consent form
You will not qualify if you...
- Women who are pregnant, breastfeeding, or planning pregnancy within six months
- Infectious diseases such as HIV, active tuberculosis, etc.
- Active hepatitis B or hepatitis C infection
- Transfection of targeted lymphocytes less than 10% or underamplification under CD3/CD28 costimulation (less than 5-fold)
- Abnormal vital signs and inability to cooperate with examinations
- Mental illness preventing cooperation with treatment and evaluation
- Severe allergies or history of severe allergies, especially to IL-2
- Systemic infection or severe local infection requiring anti-infective treatment
- Severe autoimmune disease
- Other reasons for exclusion as determined by the doctor
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Xuzhou
Xuzhou, China
Actively Recruiting
Research Team
K
Kailin Xu, PhD
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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