Actively Recruiting
Safety and Efficacy of Anti-BCMA-GPRC5D CAR-T Cells Therapy in the Treatment of r/r MM
Led by 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China · Updated on 2024-07-23
10
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
Sponsors
9
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Lead Sponsor
G
Guangzhou Bio-gene Technology Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of bispecific BCMA-GPRC5D CAR-T cells in patients with relapsed or refractory multiple myeloma who received three or more lines of therapy.
CONDITIONS
Official Title
Safety and Efficacy of Anti-BCMA-GPRC5D CAR-T Cells Therapy in the Treatment of r/r MM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The patient or guardian understands and voluntarily signs informed consent and is expected to complete study follow-up
- Age between 18 and 75 years, any gender
- Diagnosed with multiple myeloma according to international standards
- Measurable disease at screening with specified protein or light chain levels
- Relapsed or refractory after three or more treatments including proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody
- Diagnosed as relapsed/refractory or primary refractory disease
- Last treatment was ineffective or disease progressed within 60 days after last therapy
- Recovered from prior treatment toxicity (CTCAE grade less than 2) unless related to tumor and stable
- ECOG score between 1 and 2 with expected survival at least 3 months
- Liver, kidney, and cardiopulmonary functions meet specified lab and clinical criteria
- Venous access can be established without contraindications for apheresis
You will not qualify if you...
- Diagnosed or treated for aggressive cancers other than multiple myeloma
- Received targeted, epigenetic, or investigational drug therapy within 14 days or 5 half-lives before blood collection
- Suspected or confirmed central nervous system involvement of multiple myeloma
- Diagnosed with Fahrenheit macroglobulinemia, POEMS syndrome, or primary AL amyloidosis
- Positive for certain infections including hepatitis B, hepatitis C, HIV, CMV, or EBV above detection limits
- History of severe allergies
- Unstable systemic diseases such as recent angina, stroke, myocardial infarction, or severe heart failure
- Severe liver, kidney, or metabolic diseases requiring treatment
- Acute or chronic graft-versus-host disease or immunosuppressive therapy within 6 months
- Active autoimmune or inflammatory nervous system diseases
- Oncology emergencies requiring treatment before screening or infusion
- Uncontrolled infections needing antibiotics
- Recent exposure to hematopoietic growth factors or corticosteroids before apheresis
- Major surgery within 4 weeks before lymphodepletion or planned surgery during study
- Live attenuated vaccine within 4 weeks before screening
- Serious mental illness
- Alcohol or drug abuse history
- Pregnant or breastfeeding women; fertility plans within two years after CAR-T infusion
- Any other conditions judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sanbin Wang
Kunming, Kunming, Yunnan, China, 650100
Actively Recruiting
Research Team
S
Sanbin Wang, MD
CONTACT
S
Sanbin Wang, MD
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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