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Dual-targeting HER2 and PD-L1 CAR-T for Solid Tumors | Clinical Trials | Clareo Health

RECRUITINGEARLY_PHASE1

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

Phase I Study of Specific CAR-T Dual-targeting HER2 and PD-L1 for HER2-positive Solid Tumors

NCT04684459•Sichuan University

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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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);
•6. Absolute neutrophil count ≥ 1×10\^9/L, platelet count ≥ 75×10\^9/L, absolute lymphocyte count ≥0.5×10\^8/L, hemoglobin ≥ 8.0 g/dl;
•7. Creatinine clearance rate ≥60ml/min, Serum ALT/AST≤2.5 times of the normal level, and total bilirubin≤1.5 times of the normal level;
•8. Cardiac ejection fraction ≥50%, no pericardial effusion;
•9. No other serious diseases (autoimmune diseases or any immune deficiency disease or other disease in need of immunosuppressive therapy);
•10. Patients must stop chemotherapy and targeted therapy for at least 3 weeks before starting treatment;
+3 more criteria

Exclusion Criteria

•1. Allergic to cytokines;
•2. Uncontrolled activity infection;
•3. Acute or chronic (graft-versus-host disease) GVHD;
•4. Accompanied by other uncontrolled malignant tumors;
•5. Patient with hepatitis B or C active period, HIV infection ≥ the upper limit of the normal level;
•6. Suffer from serious diseases such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage, etc.;
•7. Patients with grade 2-3 hypertension or poorly controlled;
•8. History of mental illness that is difficult to control;
•9. Patients have used immunosuppressive agents for a long time after organ transplantation, except for recent or current inhaled corticosteroid therapy;
•10. The existing medical history or mental state history or laboratory abnormalities may increase the risk associated with participating in the study or the administration of the study drug;
+3 more criteria

Locations (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Key Dates

Start Date

March 12, 2021

Primary Completion Date

December 30, 2025

Completion Date

December 30, 2025

Last Updated

October 30, 2024

Enrollment

ESTIMATED participants

Conditions

Peritoneal Carcinoma MetastaticPleural Effusion, MalignantHER2 Positive Malignancies

Interventions

Dual-targeting HER2 and PD-L1 CAR-T cells

BIOLOGICAL

Contacts

Qizhi Ma, Dr

CONTACT

+8602885421139 maqzh95@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 30, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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