Actively Recruiting
Study of CT071 Injection in High Risk Newly Diagnosed Multiple Myeloma
Led by Shanghai Changzheng Hospital · Updated on 2024-06-12
10
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
S
Shanghai Changzheng Hospital
Lead Sponsor
C
CARsgen Therapeutics Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial is a single-arm, single-center, open-label clinical trial to evaluate the safety, efficacy, and metabolism kinetics of CT071 in patients with high-risk newly diagnosed multiple myeloma.
CONDITIONS
Official Title
Study of CT071 Injection in High Risk Newly Diagnosed Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteers who understand the study, sign informed consent, and can complete all trial procedures
- Age 18 years or older, any gender
- Newly diagnosed with multiple myeloma based on International Myeloma Working Group 2014 criteria
- Measurable disease with serum M-protein ≥ 1.0 g/dL, or urine M-protein ≥ 200 mg/24 hr, or involved serum free light chain level ≥ 10 mg/dL with abnormal ratio
- Presence of at least one high-risk factor: specific cytogenetic abnormalities, R-ISS stage 3 or R2-ISS stages 3 and 4, soft tissue extramedullary plasmacytoma, or 2%-5% peripheral plasma cells
- ECOG performance status score 0-2
- Adequate hematology and blood chemistry values including ANC ≥ 1.0 x 10^9/L, platelets ≥ 50 x 10^9/L, hemoglobin ≥ 7.5 g/dL, creatinine clearance ≥ 40 mL/min, liver enzymes and bilirubin within limits, and coagulation times within normal range
- Venous access available for cell collection without contraindications
- Negative pregnancy test for females of childbearing potential and agreement to use effective contraception for 12 months after infusion
- Male participants agreeing to use effective contraception for 1 year and to avoid sperm donation during study and 1 year after
You will not qualify if you...
- Non-secretory multiple myeloma
- Prior multiple myeloma treatments except up to 2 cycles of specific induction therapy; limited radiotherapy allowed
- Pregnant or breastfeeding females
- Severe mental disorders or central nervous system diseases or suspected CNS involvement
- Other active malignancies except certain successfully treated cancers
- Active autoimmune diseases requiring systemic immunosuppressants
- Uncontrolled active infections or serious viral, bacterial, or fungal infections
- Positive tests for HIV, syphilis, hepatitis B or C unless controlled
- Recent vaccination with live or mRNA vaccines within 8 weeks or inactivated vaccines within 4 weeks
- Allergies to lymphodepletion drugs, tocilizumab, CT071 components, or history of severe allergies
- Significant cardiac abnormalities including uncontrolled heart failure, recent heart attack or surgery, severe arrhythmias, or low ejection fraction
- Severe lung diseases affecting function or safety
- Need for supplemental oxygen or low oxygen saturation
- History of stroke or seizure within 6 months
- Recent or planned major surgery excluding minor procedures
- Unresolved toxicities from previous treatments except certain mild conditions
- Other conditions deemed unsuitable by investigator for trial participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Juan Du
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
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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