Actively Recruiting
Safety and Efficacy of Anti-FcRL5 CAR-T Cell Therapy in Treating Relapsed and Refractory Multiple Myeloma (R/R MM)
Led by Xuzhou Medical University · Updated on 2024-01-09
20
Participants Needed
1
Research Sites
209 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-FcRL5 CAR-T in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture. Anti-FcRL5 chimeric antigen receptor (CAR) modified T cells. Prior to Anti-FcRL5 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.
CONDITIONS
Official Title
Safety and Efficacy of Anti-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 between 18 and 70 years old
- Expected survival period of more than 12 weeks
- Diagnosed with multiple myeloma by physical, pathological, laboratory, and imaging examinations
- Have refractory multiple myeloma
- Have recurrent multiple myeloma
- ALT and AST less than 3 times normal; 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
- Able to provide blood for leukapheresis without contraindications
- Understand and voluntarily sign 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 or active tuberculosis
- Active hepatitis B or hepatitis C infection
- Less than 10% transfection of targeted lymphocytes or less than 5-fold amplification under CD3/CD28 costimulation
- Abnormal vital signs or unable to cooperate with examinations
- Mental illness preventing cooperation with treatment and evaluation
- History of severe allergies, especially to IL-2
- Systemic or severe local infections requiring treatment
- Severe autoimmune disease
- Other reasons determined by the doctor for exclusion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The affiliated hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221006
Actively Recruiting
Research Team
K
Kailin Xu, MD.,PD.
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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