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Tumor-Specific T-Cells (cCTL:GL01) for Advanced Gastrointestinal Cancer

NCT07735065 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-07-29

No results posted yet for this study

Summary

This clinical trial is designed to study an investigational cell therapy called cCTL-GL01 in patients with advanced gastrointestinal cancers (including cancers of the stomach, esophagus, colon, or rectum) that have not responded well to standard treatments.

The main goals of this study are to find out: If cCTL-GL01 is safe and what side effects it might cause; How well cCTL-GL01 works to control or shrink tumors.

Conditions

  • Advanced Gastrointestinal Cancer

Interventions

DRUG

Biological/Vaccine

Following lymphodepleting conditioning and a 2-3 day chemotherapy washout period, patients will begin receiving twice-weekly infusions of autologous cCTL cells. This study is designed such that the first three cCTL infusions for each patient will follow a stepwise dose escalation of the effective dose, specifically 1-2×107 cCTL/Kg、3-4×107 cCTL/Kg、4-5×107 cCTL/Kg; safety will be evaluated during this period to determine subsequent infusion doses. The target dose for this study is 4-5x107 cCTL/Kg per infusion, with a target frequency of twice weekly. This phase will last 2-3 weeks, with a total of 4-6 infusions. Based on the results of the first course of treatment, the investigator will determine whether to proceed with a second course of treatment. During treatment intervals, the investigator may administer bridging therapy based on the patient's clinical condition.

Sponsors & Collaborators

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2028-08-01
Completion
2028-08-01

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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 NCT07735065 on ClinicalTrials.gov