NCT04684459

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

Recruiting now EARLY_PHASE1 Last updated 30 October 2024

What this trial tests

EARLY_PHASE1 trial testing Dual-targeting HER2 and PD-L1 CAR-T cells in Peritoneal Carcinoma Metastatic in 18 participants. Currently enrolling.

Timeline

12 March 2021

Primary endpoint
30 December 2025

30 December 2025

Quick facts

Lead sponsor	Sichuan University
Phase	EARLY_PHASE1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	12 March 2021
Primary completion	30 December 2025
Estimated completion	30 December 2025
Sites	1 location across China

Drugs / interventions tested

• Dual-targeting HER2 and PD-L1 CAR-T cells — full drug profile →

Conditions studied

• Peritoneal Carcinoma Metastatic — all drugs for Peritoneal Carcinoma Metastatic →
• Pleural Effusion, Malignant — all drugs for Pleural Effusion, Malignant →
• HER2 Positive Malignancies — all drugs for HER2 Positive Malignancies →

Sponsor

Sichuan University

Who can join

Adults 18 to 75, any sex, with Peritoneal Carcinoma Metastatic or Pleural Effusion, Malignant. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. T cells in health and disease.
   Sun L, Su Y, Jiao A, Wang X, et al · · 2023 · cited 717× · PMID 37332039 · DOI 10.1038/s41392-023-01471-y
2. Current advances and challenges in CAR T-Cell therapy for solid tumors: tumor-associated antigens and the tumor microenvironment.
   Yan T, Zhu L, Chen J. · · 2023 · cited 132× · PMID 36707873 · DOI 10.1186/s40164-023-00373-7
3. Targeting myeloid-derived suppressor cells in tumor immunotherapy: Current, future and beyond.
   Zhao Y, Du J, Shen X. · · 2023 · cited 53× · PMID 37006306 · DOI 10.3389/fimmu.2023.1157537
4. Advances in CAR-T Cell Genetic Engineering Strategies to Overcome Hurdles in Solid Tumors Treatment.
   Andrea AE, Chiron A, Mallah S, Bessoles S, et al · · 2022 · cited 48× · PMID 35211124 · DOI 10.3389/fimmu.2022.830292
5. Human epidermal growth factor receptor 2 (HER2)-specific chimeric antigen receptor (CAR) for tumor immunotherapy; recent progress.
   Budi HS, Ahmad FN, Achmad H, Ansari MJ, et al · · 2022 · cited 44× · PMID 35093187 · DOI 10.1186/s13287-022-02719-0
6. A PD-L1-targeting chimeric switch receptor enhances efficacy of CAR-T cell for pleural and peritoneal metastasis.
   Ma Q, He X, Zhang B, Guo F, et al · · 2022 · cited 36× · PMID 36402752 · DOI 10.1038/s41392-022-01198-2
7. Controlling Cell Trafficking: Addressing Failures in CAR T and NK Cell Therapy of Solid Tumours.
   White LG, Goy HE, Rose AJ, McLellan AD. · · 2022 · cited 35× · PMID 35205725 · DOI 10.3390/cancers14040978
8. The Immune Landscape of Breast Cancer: Strategies for Overcoming Immunotherapy Resistance.
   Retecki K, Seweryn M, Graczyk-Jarzynka A, Bajor M. · · 2021 · cited 34× · PMID 34885122 · DOI 10.3390/cancers13236012