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Safety and Efficacy of CT0494BCP in Participants With Advanced Gastric/Esophagogastric Junction Adenocarcinoma

NCT07538856 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-04-20

No results posted yet for this study

Summary

To evaluate the safety and tolerability of CT0494BCP following infusion in participants with advanced gastric/esophagogastric junction adenocarcinoma (G/GEJA) To evaluate preliminary efficacy of CT0494BCP To evaluate the cellular metabolism kinetics of CT0494BCP The investigational drug in this study is CT0494BCP cells, including CT0494 cells and CT7095 cells. Dose escalation will be performed according to the Bayesian optimal interval (BOIN) design principle (refer to the dose escalation principle in Section 4.1 Study Design Description and the flow chart of BOIN design in Figure 2 for details) and dose expansion. In the dose escalation phase, CT0494 cells were tentatively assigned to 3 escalating doses of 3.0 × 108, 4.5 × 108 and 6.0 × 108, respectively, and CT7095 cells were tentatively assigned to 2 escalating doses of 1.5 × 108 and 3.0 × 108, respectively. If the exploratory dose is not identified as a possible recommended dose (RD), a possible RD may be explored by escalating to a higher dose or tapering to a lower dose at the discretion of the investigator and sponsor in consultation. Dose groups, number of subjects per dose group, and other escalation or de-escalation decisions may be adjusted during the study based on available data.

Conditions

  • Gastric
  • Gastric / Gastroesophageal Junction Adenocarcinoma

Interventions

DRUG

Initial Dose (Dose Group 1)

CT0494 Cell Dose 3.0 × 108 CT7095 Cell Dose 1.5 × 108

DRUG

Dose Group 2

CT0494 Cell Dose 4.5 × 108 CT7095 Cell Dose 1.5 × 108

DRUG

Dose Group 3

CT0494 Cell Dose 6.0×108 CT7095 Cell Dose 1.5×108

DRUG

Dose Group 4

CT0494 Cell Dose 3.0 × 108 CT7095 Cell Dose 3.0 × 108

DRUG

Dose Group 5

CT0494 Cell Dose 4.5 × 108 CT7095 Cell Dose 3.0 × 108

DRUG

Dose Group 6

CT0494 Cell Dose 6.0 × 108 CT7095 Cell Dose 3.0 × 108

Sponsors & Collaborators

  • Beijing GoBroad Hospital

    lead OTHER

Eligibility

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

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-04-30
Completion
2028-03-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT07538856 on ClinicalTrials.gov