Actively Recruiting
Phase I Study of TX103 CAR-T Cells in Participants With Advanced Solid Tumors
Led by Tcelltech Inc. · Updated on 2025-11-17
85
Participants Needed
2
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-arm, open-label, Phase I study to evaluate the safety, tolerability, and antitumor activity of TX103 CAR-T cells in subjects with TX103-positive advanced solid tumors. The study also aims to explore the maximum tolerated dose (MTD) and determine the recommended Phase II dose (RP2D) of TX103 CAR-T cell therapy.
CONDITIONS
Official Title
Phase I Study of TX103 CAR-T Cells in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Male or female aged 18 years or older but less than 75 years
- Pathologically confirmed B7-H3/CD276-positive advanced solid tumors
- Failed or intolerant to standard therapy
- For intraperitoneal infusion cohort: recurrent or metastatic ovarian, fallopian tube, primary peritoneal cancer, or other peritoneal metastases confined to the peritoneal cavity
- For intravenous infusion cohort: advanced solid tumors regardless of peritoneal metastasis, including certain cancers like head and neck, esophageal, lung, triple-negative breast, colorectal, and mesenchymal-derived malignancies
- B7-H3/CD276 expression of 20% or more by tumor immunohistochemistry
- At least one measurable or evaluable lesion per RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Life expectancy over 6 months
- Adequate venous access for leukapheresis
- Adequate organ function per defined hematologic, renal, hepatic, coagulation, and cardiac criteria
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective contraception from consent until 365 days after last infusion
You will not qualify if you...
- Pregnant or breastfeeding women
- Positive for HIV, syphilis, or active viral infections including hepatitis B or C with specified viral load
- Known allergies or severe reactions to TX103 CAR-T or its components, including certain chemotherapy agents
- Active autoimmune diseases needing treatment, except resolved vitiligo or childhood asthma without intervention
- Use of systemic immunosuppressive therapy or need for long-term immunosuppressants during the study
- Prior gene-engineered T-cell or gene therapy exposure
- History of organ transplantation
- Untreated or symptomatic central nervous system metastases or leptomeningeal metastases, unless stable and off corticosteroids
- Tumor invasion of major blood vessels or unclear vascular margins on imaging
- History of epilepsy or seizure disorders within one year prior to infusion
- Unresolved toxicities from prior cancer treatments not recovered to mild levels
- Major surgery or trauma within one month before leukapheresis
- Severe, acute, or chronic medical or psychiatric conditions that increase risk or interfere with study results, including uncontrolled infections or cardiac disease, uncontrolled hypertension, recent significant bleeding or thrombotic events, severe liver disease, or complete intestinal obstruction
- History or concurrent malignancy within past three years except certain treated skin cancers or carcinoma in situ
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Beijing Cancer Hospital
Beijing, China
Not Yet Recruiting
2
Beijing Gaobo Hospital
Beijing, China
Actively Recruiting
Research Team
R
Rui Feng, MD
CONTACT
X
Xianzhen Chen, MM
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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