A Phase I, Open-label, Single-arm, Dose-escalation and Expansion Study of Specific Dual-targeting CLDN18.2 and PD-L1 CAR-T for Patients with CLDN18.2-positive Advanced Solid Tumors

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Male or female, Age 18-75 years old;

• 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;

• Must have CLDN18.2-positive tumor expression ≥10% as determined by the CLDN18.2 IHC assay;

• Estimated life expectancy \> 3 months (according to investigator's judgement);

• At least 1 measurable lesion per RECIST 1.1;

• The Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;

• Sufficient venous access for leukapheresis collection and no other contraindications to leukapheresis;

• Patients should have reasonable CBC counts, renal and hepatic functions;

• No other serious diseases (autoimmune diseases or any immune deficiency disease);

⁃ 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;

⁃ 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;

⁃ Voluntarily participate in the research, understand and sign the informed consent.

Locations
Other Locations
China
West China Hospital, Sichuan University
RECRUITING
Chengdu
Contact Information
Primary
Yao Zeng
yao_zeng@stu.scu.edu.cn
(+86)15982172735
Backup
Dan Li, PhD.
lidan@wchscu.cn
(+86)13880025826
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2026-10-30
Participants
Target number of participants: 29
Treatments
Experimental: CAR-T cell therapy
Dual-targeting CLDN18.2 and PD-L1 CAR-T cells
Related Therapeutic Areas
Sponsors
Leads: Sichuan University

This content was sourced from clinicaltrials.gov

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