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

NCT06857786 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-03-04

No results posted yet for this study

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

Conditions

  • Gastroesophageal Junction Adenocarcinoma
  • Gastric Adenocarcinoma

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.

Sponsors & Collaborators

  • Peking University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-10
Primary Completion
2027-06-30
Completion
2030-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06857786 on ClinicalTrials.gov