Actively Recruiting
Biomarker-Guided Dual-Target CAR-T Cells for Advanced Solid Tumors
Led by Beijing Biotech · Updated on 2026-04-13
72
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, open-label, Phase 1/2 master protocol evaluating autologous dual-target CAR-T cell therapy in adults with advanced solid cancers. After central biomarker screening, each participant is assigned the best-matched dual-target construct from a predefined target-pair library. The trial is designed to test whether biomarkerguided dual targeting can improve tumor control, reduce antigenescape risk, and preserve safety in solid tumors.
CONDITIONS
Official Title
Biomarker-Guided Dual-Target CAR-T Cells for Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-75 years at consent
- Histologically or cytologically confirmed advanced unresectable, metastatic, or recurrent solid malignancy (including recurrent high-grade glioma for CNS-specific pairs) with no effective standard curative therapy
- At least one qualifying dual-target antigen pair found on central biomarker review based on antigen expression thresholds and acceptable normal tissue risk
- At least one measurable lesion by RECIST 1.1 or measurable/evaluable disease by RANO for CNS tumors
- ECOG performance status 0-1; CNS cohorts may allow Karnofsky score of 70 or ECOG 0-2 if justified
- Adequate organ function including specified blood counts, liver and kidney function, heart function, and oxygen saturation
- Recovery to Grade 1 or less from prior anticancer therapy toxicities except allowed exceptions
- Adequate venous access and ability to undergo leukapheresis with successful manufacture of CAR-T product
- Life expectancy of at least 12 weeks
- Negative pregnancy test for persons of childbearing potential and agreement to use effective contraception
- Ability to understand and sign informed consent and comply with long-term gene-modified cell monitoring
You will not qualify if you...
- No qualifying target pair or target pair considered unsafe after central review
- Prior gene-modified cellular therapy targeting the same pair within 6 months or ongoing significant toxicity from prior therapy
- Active uncontrolled infections including bacterial, fungal, viral infections, active tuberculosis, uncontrolled HIV, or active hepatitis B or C with unsafe viral burden
- Need for systemic corticosteroids over 10 mg prednisone equivalent daily or other systemic immunosuppressants within 7 days before lymphodepletion unless allowed for replacement or CNS edema
- Active autoimmune disease requiring immunosuppression within past 2 years except stable conditions allowed by protocol
- Clinically significant cardiovascular disease, severe lung problems, or other major health conditions making cell therapy unsafe
- Active symptomatic CNS hemorrhage, uncontrolled seizures, uncontrolled intracranial hypertension, or urgent leptomeningeal disease unless allowed in specific CNS cohort
- Pregnancy or breastfeeding
- Concurrent second cancer requiring active systemic treatment except certain low-risk or treated cancers
- Any condition judged by investigators to interfere with safe participation, product manufacture, infusion, or result interpretation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518036
Actively Recruiting
Research Team
S
shan S Lu, 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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