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NOT YET RECRUITING
NCT06857786
PHASE1

Postoperative Adjuvant Therapy for CT041 Gastric or Gastroesophageal Junction (G/GEJ) Adenocarcinoma Patients

Sponsor: Peking University

View on ClinicalTrials.gov

Summary

To evaluate the safety and tolerability of satri-cel as consolidation therapy after postoperative adjuvant therapy in patients with resected gastric or gastroesophageal junction (G/GEJ) adenocarcinoma

Official title: Open Label, Multicenter, Phase Ib Trial of CT041, Claudin 18.2 Specific CAR T Cell Therapy As a Consolidation Therapy After Adjuvant Therapy for Resected Gastric or Gastroesophageal Junction Adenocarcinoma Patients

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2025-03-10

Completion Date

2030-06-30

Last Updated

2025-03-04

Healthy Volunteers

No

Interventions

DRUG

Drug: CT041 autologous CAR T-cell injection

The planned dose of satri-cel in this trial was 2.5 × 108 cells, single infusion. The trial will start with a safety run-in phase, which is defined from the day of infusion to the 28th day after infusion for the first 6 participants. The type, grade, incidence rate, and outcome of adverse events during the safety run-in phase will be summarized and assessed by the investigator and collaborator (CARsgen Therapeutics Co., Ltd). The investigator and collaborator could discuss and assess whether the lower or higher doses should be explored based on the based on the safety and tolerability, cellular metabolic characteristics, and benefit-risk profile. If no dose adjustment is required, satri-cel dose will continue to be 2.5 × 108 cells for the rest of the participants.

Locations (3)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Beijing Gaobo Hospital

Beijing, Beijing Municipality, China

Nanjing Gulou Hospital

Nanjing, Jiangsu, China