NCT06857786

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed description

The primary objective of this trial is to evaluate the safety and tolerability of satri-cel as consolidation therapy after postoperative adjuvant therapy in patients with G/GEJ adenocarcinoma. The primary endpoint is the frequency, type, severity and outcome of AE/SAE/AESI, which is the routine assessment indicators for evaluating the safety and tolerability of the investigational product in clinical trials.

Conditions

• Gastroesophageal Junction Adenocarcinoma
• Gastric Adenocarcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-10
• Primary completion: 2027-06-30
• Completion: 2030-06-30
• First posted: 2025-03-04
• Last updated: 2025-03-04

Locations

3 sites across 1 country: China