Actively Recruiting
A Phase I Study to Evaluate Safety and Early Effectiveness of Anti-CDH17 CAR-T Cells in CDH17-positive Advanced Solid Tumors
Led by 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China · Updated on 2025-02-11
30
Participants Needed
1
Research Sites
21 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
Researchers are evaluating the safety and preliminary effectiveness of anti-CDH17 CAR-T cell therapy in patients with advanced solid tumors that test positive for the CDH17 marker. This early-phase, single-center, open-label study aims to understand how this new treatment works in patients who have no standard treatment options or for whom previous treatments have not been effective. The therapy involves genetically modifying a patient's T cells to target cancer cells expressing CDH17. The treatment process includes collecting the patient's T cells through a leukapheresis procedure, followed by lymphodepleting chemotherapy using fludarabine and cyclophosphamide before receiving the anti-CDH17 CAR-T cell infusion. This study involves a single treatment group receiving this investigational cell therapy. Researchers will monitor patients for safety and preliminary signs of treatment effect over time. Participants will undergo regular assessments including monitoring for adverse events within one year after infusion. Researchers will measure response rates, CAR-T cell levels in the blood at multiple time points up to 52 weeks, and track progression-free and overall survival during this period. Patients are expected to have follow-up visits and evaluations to carefully assess the treatment's impact and any side effects for up to one year post-infusion.
CONDITIONS
Brief Title
Safety and Preliminary Efficacy of Anti-CDH17 CAR-T Cell Therapy in Patients with CDH17-positive Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient voluntarily signs informed consent and plans to complete study follow-up
- Age between 18 and 75 years, any gender
- Has CDH17-positive tumor confirmed by immunohistochemistry in approved lab
- Has at least one measurable extracranial tumor lesion
- Estimated survival of at least 12 weeks
- ECOG performance status of 0 or 1
- Recovered from prior treatment toxicity with CTCAE grade less than 2, unless tumor-related or stable
- Has venous access suitable for leukapheresis and no contraindications
You will not qualify if you...
- Current or prior other malignancies besides target tumor
- Brain metastases or significant central nervous system disease
- Prior targeted, epigenetic, or investigational drug therapy within 14 days or five half-lives before blood collection
- Positive for hepatitis B, hepatitis C, HIV, cytomegalovirus, or Epstein-Barr virus with detectable viral DNA
- Positive tuberculosis sputum smear or T-cell test
- History or evidence of severe lung diseases or impaired lung function
- Severe allergic history
- Severe heart disease or uncontrolled hypertension
- Severe liver or kidney dysfunction or consciousness disorders
- Active autoimmune or inflammatory nervous system diseases
- Uncontrolled infections requiring antibiotics
- Live attenuated vaccine within 4 weeks before screening
- History of alcohol or drug abuse
- Pregnant or breastfeeding women or plans for pregnancy within two years
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment period with follow-up assessments for up to 52 weeks post-infusion
Participants receive lymphodepleting therapy followed by a single intravenous infusion of anti-CDH17 CAR-T cells.
Multiple visits including leukapheresis, infusion, and frequent monitoring visits especially in the first month after infusion
Duration - Up to 52 weeks post-infusion
Participants are monitored for safety and efficacy outcomes including adverse events, tumor response, and survival for up to 52 weeks after CAR-T cell infusion.
Visits on Days 2, 5, 8, 11, 14, 21, 28, 35 and weeks 6, 12, 18, 26, 34, 42, and 52 after infusion
Trial Site Locations
Total: 1 location
1
Sanbin Wang
Kunming, Yunnan, China, 650100
Actively Recruiting
Research Team
S
Sanbin Wang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Frequently Asked Questions
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