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Recruiting EARLY_Phase 1 NCT04684459

Dual-targeting HER2 and PD-L1 CAR-T for Solid Tumors

◆ AI Clinical Summary

This study tests a new type of immunotherapy called CAR-T cells that are designed to fight cancer by targeting two proteins (HER2 and PD-L1) commonly found on cancer cells. Researchers are investigating whether this dual-targeting approach can effectively treat peritoneal carcinoma (cancer in the abdominal lining) that has spread to other parts of the body.

Key Objective: This trial is testing whether CAR-T cells that target both HER2 and PD-L1 can more effectively shrink or control peritoneal carcinoma and metastatic cancers compared to standard treatments.

Who to Consider: Patients with peritoneal carcinoma or metastatic solid tumors that express HER2 and PD-L1 who have limited options with standard treatments should consider enrolling.

Trial Parameters

Condition Peritoneal Carcinoma Metastatic
Sponsor Sichuan University
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 18
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2021-03-12
Completion 2025-12-30
Interventions
Dual-targeting HER2 and PD-L1 CAR-T cells

Brief Summary

CAR-T therapy has achieved unprecedented success in hematological tumors in recent years, but the progress of CAR-T cells in the treatment of solid tumors is facing difficulties. HER-2 is frequently expressed in breast cancer, ovarian cancer, lung cancer, gastric cancer and other malignant tumors. In this study, the PD-L1 inhibitory signal was transformed into an activation signal in the tumor microenvironment, and enhanced the killing activity and survival ability of CAR-T cells. The HER-2/PD-L1 dual-targeting CAR-T will be investigated in patients with HER2-positive solid tumors, and all enrolled subjects will receive HER2/PD-L1 CAR T cells via intravenous or thoracic/peritoneal cavity infusion.

Eligibility Criteria

Inclusion Criteria: 1. Male or female, Age 18-75 years old; If the subjects are over 75 years old, the researchers will determine whether to enroll according to the basic health conditions of the subjects, regardless of gender. No upper age limit was set for chest/abdominal reinfusion CAR-T subjects. 2. Estimated life expectancy ≥ 3 months (according to investigator's judgement); 3. The Eastern Cooperative Oncology Group (ECOG) performance status score is 0-2; 4. Patients diagnosed as ovarian cancer, non-small cell lung cancer, breast cancer, gastric cancer, head and neck cancer, pancreatic cancer, colorectal cancer, transitional cell carcinoma, endometrial carcinoma, sarcoma, glioblastoma, cholangiocarcinoma, etc. have received standard systemic treatment, have systemic metastasis/serosal cavity metastasis or are not tolerated; 5. Expressing HER2 \>20% of primary tumors or metastatic cells in the serous cavity by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH);

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