Actively Recruiting
A Platform Study of In Vivo CAR-T for Treating Advanced Malignant Tumors Based on Target Screening
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2026-05-13
50
Participants Needed
1
Research Sites
105 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-arm, open-label, single-center, dose-escalation Phase I platform study designed to evaluate the safety, tolerability, preliminary efficacy, pharmacokinetics, and pharmacodynamics of an in vivo CAR-T therapy (V001 Injection, targeting BCMA, GPRC5D, DLL3,FcRH5, etc.) in patients with advanced malignant tumors.
CONDITIONS
Official Title
A Platform Study of In Vivo CAR-T for Treating Advanced Malignant Tumors Based on Target Screening
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed advanced blood cancers (e.g., multiple myeloma, lymphoma) or solid tumors (e.g., small cell lung cancer) that have returned or did not respond to treatment
- Tumor cells must express the relevant target (e.g., BCMA, GPRC5D, DLL3) for the specific study group
- ECOG performance status 0 to 2 for blood cancers or 0 to 1 for solid tumors, with life expectancy of at least 3 months
- Adequate organ function, including creatinine clearance of 45 mL/min or higher and left ventricular ejection fraction of 45% or higher
- Patients able and willing to use effective contraception during the study and for 1 year after treatment if of childbearing potential
- Signed informed consent form
You will not qualify if you...
- Active, uncontrolled infection
- Active central nervous system metastases or involvement
- Prior anticancer treatment, radiotherapy, or investigational therapy within specified timeframes before first study dose
- Severe heart or lung disease (e.g., NYHA Class III/IV heart failure), severe liver or kidney impairment
- Active infection with Hepatitis B, Hepatitis C, HIV, or syphilis
- Prior allogeneic hematopoietic stem cell transplant within specified time or active graft-versus-host disease
- Pregnancy or breastfeeding
- History of severe allergy to any components of the investigational treatment
- Any other condition that the investigator believes may increase risk or interfere with study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital Chinese Academy of Medical Sciences 17 Panjiayuan Nanli, Chaoyang District
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
L
Li Ning, M.D.
CONTACT
S
Shuhang Wang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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