Status:
RECRUITING
Dual-targeting CLDN18.2 and PD-L1 CAR-T for Patients with CLDN18.2-positive Advanced Solid Tumors
Lead Sponsor:
Sichuan University
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
Claudin18.2(CLDN18.2) is a kind of integrin membrane protein in the tight junction between epithelium and endothelium, which is highly expressed in many solid tumors, especially in gastric cancer and ...
Detailed Description
In this study, the CLDN18.2/PD-L1 dual-targeting CAR-T cells will be injected intravenously to patients with CLDN18.2-positive advanced solid tumors, such as gastric adenocarcinoma or gastroesophageal...
Eligibility Criteria
Inclusion
- Male or female, Age 18-75 years old;
- Patients with pathologically/histologically confirmed diagnosis of solid tumors (such as advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma and pancreatic adenocarcinoma) have received at least once systemic standard treatment and disease progressed; or refused/ cannot tolerate the subsequential standard treatment after the first line treatment;
- Must have CLDN18.2-positive tumor expression ≥10% as determined by the CLDN18.2 IHC assay;
- Estimated life expectancy \> 3 months (according to investigator's judgement);
- At least 1 measurable lesion per RECIST 1.1;
- The Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Sufficient venous access for leukapheresis collection and no other contraindications to leukapheresis;
- Patients should have reasonable CBC counts, renal and hepatic functions;
- No other serious diseases (autoimmune diseases or any immune deficiency disease);
- Women of childbearing age must undergo a serum pregnancy test with negative results before screening and infusion and be willing to use effective and reliable method of contraception for at least 12-months after T-cell infusion;
- Men must be willing to use effective and reliable method of contraception and are not allowed to donate sperm for at least 12-months after T-cell infusion;
- Voluntarily participate in the research, understand and sign the informed consent.
Exclusion
- Pregnant or lactating women;
- Patient with hepatitis B or C active period, HIV infection ≥ the upper limit of the normal level;
- Any uncontrolled active infection;
- Patients who have clinically significant thyroid dysfunction;
- Patients who have received prior cellular therapy such as CAR T, TCR, tumor-infiltrating lymphocytes;
- Patients who are allergic to immunotherapy or any associated drugs, such as cytokines and the preconditioning regimen (cyclophosphamide, fludarabine);
- Patients with untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression;
- Patients have clinical significant cardiac conditions that researchers believe that participating in this clinical trial may endanger the health of the patients;
- Unstable pulmonary embolism, deep venous embolism or other major arterial/venous thromboembolic events occurred within 6 months before enrollment;
- Patients with active autoimmune diseases, history of autoimmune diseases or other diseases in need of immunosuppressive therapy;
- Patients with major surgery or injury less than 4 weeks prior to leukapheresis or plan to have major surgery during the research period;
- Patients with second malignancies in addition to targeted malignancies within 5 years before screening;
- Patients with unstable/active ulcer or digestive tract bleeding;
- Patient suffering from diseases that affect the signing of written informed consent or compliance with research procedures; or are unwilling or unable to comply with research requirements;
- Patients who have a history or a tendency for digestive tract bleeding;
- Patients who are inappropriate to participate in this research as considered by PI.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2026
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT06084286
Start Date
January 1 2024
End Date
October 30 2026
Last Update
November 19 2024
Active Locations (1)
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1
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041