NCT06084286 Dual-targeting CLDN18.2 and PD-L1 CAR-T for Patients with CLDN18.2-positive Advanced Solid Tumors
| NCT ID | NCT06084286 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Sichuan University |
| Condition | Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 29 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2026-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 29 participants in total. It began in 2024-01-01 with a primary completion date of 2026-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 pancreatic cancer. The CLDN18.2/PD-L1 dual-targeting CAR-T will be investigated in patients with CLDN18.2-positive advance solid tumors.
Eligibility Criteria
Inclusion Criteria: 1. Male or female, Age 18-75 years old; 2. 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; 3. Must have CLDN18.2-positive tumor expression ≥10% as determined by the CLDN18.2 IHC assay; 4. Estimated life expectancy \> 3 months (according to investigator's judgement); 5. At least 1 measurable lesion per RECIST 1.1; 6. The Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 7. Sufficient venous access for leukapheresis collection and no other contraindications to leukapheresis; 8. Patients should have reasonable CBC counts, renal and hepatic functions; 9. No other serious diseases (autoimmune diseases or any immune deficiency disease); 10. 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; 11. 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; 12. Voluntarily participate in the research, understand and sign the informed consent. Exclusion Criteria: 1. Pregnant or lactating women; 2. Patient with hepatitis B or C active period, HIV infection ≥ the upper limit of the normal level; 3. Any uncontrolled active infection; 4. Patients who have clinically significant thyroid dysfunction; 5. Patients who have received prior cellular therapy such as CAR T, TCR, tumor-infiltrating lymphocytes; 6. Patients who are allergic to immunotherapy or any associated drugs, such as cytokines and the preconditioning regimen (cyclophosphamide, fludarabine); 7. Patients with untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression; 8. Patients have clinical significant cardiac conditions that researchers believe that participating in this clinical trial may endanger the health of the patients; 9. Unstable pulmonary embolism, deep venous embolism or other major arterial/venous thromboembolic events occurred within 6 months before enrollment; 10. Patients with active autoimmune diseases, history of autoimmune diseases or other diseases in need of immunosuppressive therapy; 11. Patients with major surgery or injury less than 4 weeks prior to leukapheresis or plan to have major surgery during the research period; 12. Patients with second malignancies in addition to targeted malignancies within 5 years before screening; 13. Patients with unstable/active ulcer or digestive tract bleeding; 14. 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; 15. Patients who have a history or a tendency for digestive tract bleeding; 16. Patients who are inappropriate to participate in this research as considered by PI.
Contact & Investigator
YongShen Wang, Prof.
PRINCIPAL INVESTIGATOR
West China Hospital
Frequently Asked Questions
Who can join the NCT06084286 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Advanced Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06084286 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06084286 currently recruiting?
Yes, NCT06084286 is actively recruiting participants. Contact the research team at yao_zeng@stu.scu.edu.cn for enrollment information.
Where is the NCT06084286 trial being conducted?
This trial is being conducted at Chengdu, China.
Who is sponsoring the NCT06084286 clinical trial?
NCT06084286 is sponsored by Sichuan University. The principal investigator is YongShen Wang, Prof. at West China Hospital. The trial plans to enroll 29 participants.