NCT05477927

Dual-targeting VEGFR1 and PD-L1 CAR-T for Cancers Patients With Pleural or Peritoneal Metastases

A Phase Ia/Ib, Open-label, Single-arm, Dose-escalation and Expansion Study of Specific Dual-targeting VEGFR1 and PD-L1 CAR-T in Cancer Patients With Pleural or Peritoneal Metastases

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Sichuan University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Serosal cavity metastases of malignant tumor seriously affects the quality of life and survival time of patients with cancers in advanced stage. VEGFR1 is frequently expressed in breast cancer, ovarian cancer, lung cancer, gastric cancer and other malignant tumors and their metastases. The VEGFR1/PD-L1 dual-targeting CAR-T will be investigated in cancer patients with serosal cavity metastases.

Detailed description

In this study, VEGFR1 will be used as the general target of serosal cavity metastasis of malignant tumor, and the dual-targeting CAR-T of VEGFR1/PD-L1 will be injected in to pleural or peritoneal cavity of patients with advanced serous cavity metastases, such as ovarian cancer, breast cancer, lung cancer and gastric cancer, who had nearly no response to standard treatment. The safety and effectiveness will be evaluated. The safety evaluation standard refers to the standard of CTCAE 5.0. The evaluation standard of effectiveness refers to the evaluation standard of solid tumor curative effect RECIST 1.1 to evaluate the curative effect. There are two part of this study, the first is dose escalation part, 18 patients with malignant tumor (failure of standard treatment will be enrolled at least, patients with peritonea cavity metastases are planned to be enrolled in the cohort 1, and those with pleural cavity metastasis are enrolled in the cohort 2. The second is dose expansion part, the curative effect has observed in the first part, and after the DLT observation period of the related dose group was finished, the PI will decided whether to conduct the dose expansion research finally. It was planned to enroll 40 patients with serous cavity metastases , two cohorts were divided the same as mentioned above in dose escalation part.

Conditions

• Malignant Peritoneal Effusion
• Malignant Ascites
• Serous Cavity Metastatises

Interventions

Type	Name	Description
BIOLOGICAL	Dual-targeting VEGFR1 and PD-L1 CAR-T cells	In the dose escalation part, the dose levels will be escalated following a traditional escalation scheme for 3+3 design. In the dose expansion part, patients will be assigned to different groups based on pleural or peritoneal metastases condition.

Timeline

• Start date: 2023-11-28
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2022-07-28
• Last updated: 2023-11-29

Locations

1 site across 1 country: China