Actively Recruiting
Sequential CAR-T Cells Targeting BCMA/GPRC5D in Patients With Relapsed/ Refractory Multiple Myeloma
Led by Essen Biotech · Updated on 2025-06-22
60
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open, single-arm, clinical study to evaluate the efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) targeting BCMA or GPRC5D or both sequentially in the treatment of Relapsed/ Refractory Multiple myeloma
CONDITIONS
Official Title
Sequential CAR-T Cells Targeting BCMA/GPRC5D in Patients With Relapsed/ Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Expected survival time of at least 3 months
- Diagnosed with relapsed or refractory Multiple Myeloma who have failed standard treatments or lack effective treatment
- Histological evidence of non-suppurative destructive cholangitis and small bile duct destruction
- Liver and kidney function within specified limits: creatinine 1.5 times upper limit of normal (ULN); total bilirubin 2 times ULN; ALT and AST 2.5 times ULN (or up to 5 times ULN if due to disease)
- Electrocardiogram shows no clinically significant abnormalities
- Blood oxygen saturation above 91% without oxygen support
- No serious mental disorders
- Able to understand the study and provide signed informed consent
You will not qualify if you...
- Malignant tumors other than relapsed/refractory autoimmune disease (AID) within 5 years prior to screening, except certain treated cancers
- Positive for hepatitis B surface antigen or core antibody without normal viral levels, hepatitis C antibody and RNA positive, HIV antibody positive, or syphilis positive
- Serious heart disease including unstable angina, recent myocardial infarction or surgery within 6 months, congestive heart failure class III or higher, or severe arrhythmia
- Unstable systemic diseases such as severe liver, kidney, or metabolic conditions requiring treatment
- Active or uncontrolled infections requiring systemic therapy within 7 days prior to treatment
- Pregnant or lactating women, or planning pregnancy within 2 years after cell transfusion
- Previous CAR-T or gene-modified cell therapy before screening
- Participation in other clinical studies within 1 month before screening
- Evidence of central nervous system invasion
- Mental health issues including depression or suicidal thoughts
- Other situations deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
District One Hospital
Beijing, Beijing Municipality, China, 086-373
Actively Recruiting
Research Team
R
Rhoda M Smith, 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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