Actively Recruiting
Chimeric Antigen Receptor Modified T Cells Targeting BCMA for the Treatment of Relapsed/Refractory Multiple Myeloma
Led by The First Affiliated Hospital of Xiamen University · Updated on 2024-09-25
5
Participants Needed
1
Research Sites
222 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the safety and tolerability of chimeric antigen receptor gene-modified T cells targeting BCMA for the treatment of relapsed/refractory multiple myeloma
CONDITIONS
Official Title
Chimeric Antigen Receptor Modified T Cells Targeting BCMA for the Treatment of Relapsed/Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years, any gender
- Diagnosed with relapsed or refractory multiple myeloma confirmed by physical, pathological, laboratory, and imaging tests
- BCMA expression confirmed in myeloma cells by flow cytometry or histology
- Expected survival time greater than 3 months as judged by the investigator
- ECOG performance status score of 2 or less, Karnofsky Performance Status over 60%
- Adequate liver, kidney, heart, and lung function with specified lab values: ALT and AST ≤2.5× ULN (up to 5× ULN if liver involved), total bilirubin <34 µmol/L, creatinine clearance >30 mL/min, heart ejection fraction ≥40%, no significant arrhythmia, and indoor oxygen saturation ≥92%
- Peripheral blood lymphocyte absolute count ≥0.5×10^9/L, platelet count >30×10^9/L, hemoglobin >80 g/L, single venous access for collection, and no contraindications for hematopoietic cell separation
- Agreement to use highly effective contraception if of reproductive potential
- Ability to understand and voluntarily sign informed consent
You will not qualify if you...
- Pregnant or nursing women, or women planning pregnancy within six months
- Positive tests for hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus
- History of other tumors except cured skin or cervical in situ cancers with no active disease
- Previous treatment targeting BCMA
- Autologous hematopoietic stem cell transplantation within the last 6 weeks
- Uncontrolled active bacterial or fungal infection
- Allergic to study-related drugs or cell components
- Active autoimmune diseases
- Unstable or active ulcers or gastrointestinal bleeding
- Mental or psychological disorders preventing cooperation with treatment or evaluation
- Use of other experimental drugs within the last 3 months
- Any other reason deemed unsuitable by the researcher for participation in the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361000
Actively Recruiting
Research Team
B
Bing Xu
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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