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

Sponsor
Peking University
Study ID
NCT06857786
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Drug: CT041 autologous CAR T-cell injection — DRUG
    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.

Study Details

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

Key Dates

First listed
Mar 4, 2025
Start date
Mar 10, 2025
Status verified
Feb 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2030

Study Design

Enrollment
48 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1b, open-label, single-arm trial
    Drug: CT041 autologous CAR T-cell injection

Primary Outcome Measure

Incidence, type, and severity of adverse events [ Time Frame: Signed ICF to 15 years after CT041 infusion ]

Central Contacts

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