Advanced Gastrointestinal CancerPhase 1cCTLNCT07735065
Tumor-Specific T-Cells (cCTL:GL01) for Advanced Gastrointestinal Cancer
A Phase 1 study testing Biological/Vaccine in people with Advanced Gastrointestinal Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Advanced Gastrointestinal Cancer
- What is being tested?
- Biological/Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 Aug 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years (inclusive), male or female;
- Ability to understand the study and has signed the written Informed Consent Form (ICF), and is willing and able to comply with all protocol-required procedures;
- Fresh tumor tissue samples can be obtained via biopsy or surgery, and peripheral blood mononuclear cells (PBMCs) can be obtained via apheresis;
- Histologically and/or cytologically confirmed advanced gastrointestinal solid tumors (e.g., esophageal cancer, gastric cancer, colon cancer, etc.), with previous receipt of at least one systemic therapy that failed or resulted in recurrence; OR previous receipt of any form of immunotherapy or cellular therapy that failed or resulted in recurrence;
- Presence of at least one measurable lesion according to RECIST v1.1, or has an evaluable target lesion/disease assessment method as determined by the investigator. (Note: A measurable lesion is defined as a non-nodal lesion with at least one dimension ≥ 10 mm, or a nodal lesion with a short axis ≥ 15 mm, measured by CT/MRI; lesions previously treated with local therapies [e.g., radiotherapy] cannot be considered as target lesions unless clear disease progression is documented.)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1;
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- Life expectancy ≥ 20 weeks;
- Hepatitis B virus (HBV) infected patients (with HBV DNA levels below the lower limit of detection [LLOD]), or cured Hepatitis C virus (HCV) infected patients;
- Laboratory values within 14 days prior to the first dose of study drug must meet the following criteria:
- Hematology: Absolute neutrophil count (ANC) ≥1.5×109/L; Platelets (PLT) ≥100×109/L; Hemoglobin (Hb) ≥90g/L; Note: The above requirements must be met without receiving any transfusion of blood components or supportive therapy with cell growth factors within two weeks prior to blood collection.
- Renal Function: Serum creatinine ≤1.5×upper limit of normal (ULN) OR creatinine clearance (CrCl) ≥50mL/min (calculated using the Cockcroft-Gault formula).
- Hepatic Function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.0×ULN (for patients with liver metastases, ALT and AST ≤3.0×ULN); Serum total bilirubin (TBIL) ≤1.5×ULN.
- Coagulation Function: International Normalized Ratio (INR) or prothrombin time (PT) ≤1.5×ULN (for patients receiving warfarin anticoagulation, INR must be between 1.5 and 2.5); activated partial thromboplastin time (aPTT) ≤1.5×ULN.
- Female patients of childbearing potential must have a confirmed negative serum pregnancy test within 3 days prior to the first dose of study drug, and must initiate effective contraception immediately following the negative result; patients of childbearing potential and their partners must agree to use highly effective contraception throughout the study drug treatment period and for 90 days after the last dose of study drug.
- Adverse events (AEs) related to prior anti-cancer therapy must have resolved to Grade 0 or 1; the following AEs are permitted for enrollment: alopecia, Grade ≤2 sensory neuropathy, and endocrine disorders controlled by hormone replacement therapy.
Who cannot join
- History of a second primary malignancy within 5 years (inclusive) prior to screening, except for cured cervical carcinoma in situ, localized skin squamous cell carcinoma, basal cell carcinoma, ductal carcinoma in situ (DCIS) of the breast, <T1 urothelial carcinoma, or prostate cancer under active surveillance;
- Patients with Gilbert's syndrome;
- Patients with anorexia, nausea, or vomiting of Grade≥2;
- History of bowel obstruction or intestinal perforation within 6 months prior to screening;
- Patients who experienced Grade≥3 toxicity related to prior irinotecan use;
- Symptomatic brain metastases or leptomeningeal metastases; or other evidence indicating that central nervous system (CNS) metastases or leptomeningeal metastases are uncontrolled, and the investigator deems the patient unsuitable for enrollment. Patients with asymptomatic brain metastases or those stable after treatment (receiving≤10mg/day of prednisone or equivalent systemic corticosteroids), with both imaging and neurological examinations judged to be stable following relevant treatment, are permitted to be enrolled;
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- History of cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction (MI), unstable angina, or New York Heart Association (NYHA) Class III or IV heart failure within 24 weeks prior to enrollment; history of malignant arrhythmia within 12 weeks prior to enrollment; or QTcF > 450 ms in males or QTcF > 470 ms in females;
- Active autoimmune disease, or a history of autoimmune disease requiring systemic treatment within 2 years prior to screening. The following conditions are permitted for enrollment: hypothyroidism, vitiligo, Graves' ophthalmopathy, Hashimoto's thyroiditis, Type I diabetes mellitus, childhood asthma, or allergic asthma with no acute exacerbations/attacks within 2 years prior to screening;
- Prior history of allogeneic stem cell transplantation or solid organ transplantation;
- History of severe allergic reactions, Grade 3-4 hypersensitivity to humanized antibody or fusion protein therapies, or known hypersensitivity to irinotecan;
- History of Grade 3-4 immune-related adverse events (irAEs) or those leading to permanent discontinuation of treatment (except for Grade 3 endocrine abnormalities controlled by hormone replacement therapy);
- Receipt of >10mg/day of prednisone (or equivalent systemic corticosteroids) or other immunosuppressants for≥5 consecutive days within 2 weeks prior to screening; however, short-course (≤1 week) of topical, ocular, intra-articular, intranasal, or inhaled administration is permitted;
- Receipt of any live vaccine within 4 weeks prior to enrollment;
- Presence of any of the following: Active bacterial infection requiring intravenous anti-infective therapy within 2 weeks prior to the first dose of study drug; Positive for human immunodeficiency virus (HIV) (HIV-1/2 antibodies); Active tuberculosis (TB) currently receiving anti-TB treatment or having received anti-TB treatment within 1 year prior to screening;
- Receipt of anti-cancer therapy or radiotherapy within 4 weeks or 5 half-lives (whichever is longer) prior to enrollment. Palliative radiotherapy for symptom control is permitted but must be completed at least 2 weeks prior to the first dose of study drug, and no additional radiotherapy is planned for the same lesions;
- Patients who underwent major surgery, interventional therapy/ablation therapy, experienced major trauma within 4 weeks prior to the first dose of study drug, or require elective major surgery during the study period (excluding needle biopsy, aspiration drainage, bronchoscopy, or intravenous cannulation);
- Participation in any drug or medical device clinical trial within 4 weeks prior to the first dose of study drug;
- Presence of psychiatric disorders, psychological illness, or familial genetic diseases that may affect the conduct of the clinical trial;
- According to the investigator's judgment, any condition that may interfere with disease staging, treatment, and follow-up, affect patient compliance, or place the patient at high risk;
- Any other severe underlying diseases or reasons that, in the opinion of the investigator, make the patient unsuitable for participation in the clinical trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-Arm, Interventional, Exploratory Clinical Study of Tumor-Specific Cytotoxic T-Cell Injection (cCTL:GL01) for the Treatment of Advanced Gastrointestinal Tumors
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.
Read the detailed description
cCTL-GL01 is a cellular immunotherapy utilizing specialized T-cells engineered to recognize, target, and eliminate cancer cells. For patients enrolled in this clinical study, the therapeutic process comprises the following phases:
Preconditioning (Pre-treatment): Patients undergo a short course of lymphodepleting conditioning to optimize the host immune environment and facilitate the engraftment and expansion of the infused T-cells.
cCTL-GL01 Infusion and Combination Therapy: cCTL-GL01 cells are administered via intravenous (IV) infusion, supplemented by a combination therapy designed to enhance the in vivo persistence and therapeutic efficacy of the infused T-cells.
Safety and Efficacy Monitoring: Subjects undergo rigorous monitoring to ensure clinical safety and evaluate therapeutic response. This includes active surveillance for immunotherapy-related adverse events (particularly Cytokine Release Syndrome, or CRS), routine laboratory examinations (blood panels), and regular radiographic assessments (e.g., CT or MRI scans) to evaluate tumor response.
- Conditions
- Advanced Gastrointestinal Cancer
- Being tested
- Biological/Vaccine
- Keywords
- Tumor specific T cell, Cell Therapy, Gastrointestinal Cancer
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological/VaccineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| cCTL:GL01 Injection group | Experimental | Patients received i.v. infusion of cCTL:GL01 Receives: Drug: Biological/Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
dose-limiting toxicities (DLTs)
To evaluate safety, the investigator will monitor the number of participants experiencing treatment-related adverse events (AEs) and dose-limiting toxicities (DLTs), assessing their incidence, type, severity, and causality. All AEs, including immunotherapy-related reactions such as cytokine release syndrome (CRS), will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. The primary parameters to be evaluated are as follows:
①Blood pressure: Changes in patients' blood pressure will be closely monitored throughout the treatment. The measurement data will be reported and aggregated in millimeters of mercury (mmHg).
②Pulse: Patients' pulse will be continuously monitored throughout the trial to evaluate physiological stability and acute reactions following treatment administration. The measurement data will be reported in beats per minute (bpm).
③Inflammatory Markers: Blood inflammatory markers, specifically C-reactive prote
Measured: From Week 1 through Week 16 of treatment
Secondary outcomes (5)
Objective response rate (ORR)
The percentage of participants achieving a Complete Response (CR) or Partial Response (PR). Tumor response will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: Up to Week 16 post-treatment (with imaging assessments up to approximately 12 months or until disease progression)
disease control rate (DCR)
The percentage of participants achieving a Complete Response (CR), Partial Response (PR), or Stable Disease (SD). This will be assessed according to RECIST v1.1.
Measured: Up to Week 16 post-treatment (with imaging assessments up to approximately 12 months or until disease progression)
Progression-free survival (PFS)
The time from the start of treatment to the date of first documented disease progression (assessed via RECIST v1.1) or death from any cause, whichever occurs first. Measurement data will be reported in weeks or months.
Measured: Up to approximately 24 months.
overall survival (OS)
The time from the start of treatment to the date of death from any cause. Measurement data will be reported in weeks or months.
Measured: Up to approximately 24 months.
duration of response (DOR)
The time from the first documentation of objective tumor response (CR or PR) to the first documented disease progression (assessed per RECIST v1.1) or death from any cause. Measurement data will be reported in weeks or months.
Measured: Up to approximately 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gastrointestinal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735065
- Sponsor's protocol ID
- SC2026-0005-02
- Acronym
- cCTL
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Interventional, Exploratory Clinical Study of Tumor-Specific Cytotoxic T-Cell Injection (cCTL:GL01) for the Treatment of Advanced Gastrointestinal Tumors
- ClinicalTrials.gov ID
- NCT07735065
- Acronym / sponsor ID
- cCTL / SC2026-0005-02
- Conditions
- Advanced Gastrointestinal Cancer
- Keywords
- Tumor specific T cell, Cell Therapy, Gastrointestinal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
cCTL-GL01 is a cellular immunotherapy utilizing specialized T-cells engineered to recognize, target, and eliminate cancer cells. For patients enrolled in this clinical study, the therapeutic process comprises the following phases:
Preconditioning (Pre-treatment): Patients undergo a short course of lymphodepleting conditioning to optimize the host immune environment and facilitate the engraftment and expansion of the infused T-cells.
cCTL-GL01 Infusion and Combination Therapy: cCTL-GL01 cells are administered via intravenous (IV) infusion, supplemented by a combination therapy designed to enhance the in vivo persistence and therapeutic efficacy of the infused T-cells.
Safety and Efficacy Monitoring: Subjects undergo rigorous monitoring to ensure clinical safety and evaluate therapeutic response. This includes active surveillance for immunotherapy-related adverse events (particularly Cytokine Release Syndrome, or CRS), routine laboratory examinations (blood panels), and regular radiographic assessments (e.g., CT or MRI scans) to evaluate tumor response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cCTL:GL01 Injection group | Experimental | Drug: Biological/VaccinePatients received i.v. infusion of cCTL:GL01 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age 18 to 65 years (inclusive), male or female;
- Ability to understand the study and has signed the written Informed Consent Form (ICF), and is willing and able to comply with all protocol-required procedures;
- Fresh tumor tissue samples can be obtained via biopsy or surgery, and peripheral blood mononuclear cells (PBMCs) can be obtained via apheresis;
- Histologically and/or cytologically confirmed advanced gastrointestinal solid tumors (e.g., esophageal cancer, gastric cancer, colon cancer, etc.), with previous receipt of at least one systemic therapy that failed or resulted in recurrence; OR previous receipt of any form of immunotherapy or cellular therapy that failed or resulted in recurrence;
- Presence of at least one measurable lesion according to RECIST v1.1, or has an evaluable target lesion/disease assessment method as determined by the investigator. (Note: A measurable lesion is defined as a non-nodal lesion with at least one dimension ≥ 10 mm, or a nodal lesion with a short axis ≥ 15 mm, measured by CT/MRI; lesions previously treated with local therapies [e.g., radiotherapy] cannot be considered as target lesions unless clear disease progression is documented.)
Key exclusion criteria (20 listed)
- History of a second primary malignancy within 5 years (inclusive) prior to screening, except for cured cervical carcinoma in situ, localized skin squamous cell carcinoma, basal cell carcinoma, ductal carcinoma in situ (DCIS) of the breast, <T1 urothelial carcinoma, or prostate cancer under active surveillance;
- Patients with Gilbert's syndrome;
- Patients with anorexia, nausea, or vomiting of Grade≥2;
- History of bowel obstruction or intestinal perforation within 6 months prior to screening;
- Patients who experienced Grade≥3 toxicity related to prior irinotecan use;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological/VaccineFollowing 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. | Drug | cCTL:GL01 Injection group |
Primary outcome
dose-limiting toxicities (DLTs)
Time frame: From Week 1 through Week 16 of treatment
To evaluate safety, the investigator will monitor the number of participants experiencing treatment-related adverse events (AEs) and dose-limiting toxicities (DLTs), assessing their incidence, type, severity, and causality. All AEs, including immunotherapy-related reactions such as cytokine release syndrome (CRS), will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. The primary parameters to be evaluated are as follows: ①Blood pressure: Changes in patients' blood pressure will be closely monitored throughout the treatment. The measurement data will be reported and aggregated in millimeters of mercury (mmHg). ②Pulse: Patients' pulse will be continuously monitored throughout the trial to evaluate physiological stability and acute reactions following treatment administration. The measurement data will be reported in beats per minute (bpm). ③Inflammatory Markers: Blood inflammatory markers, specifically C-reactive prote
5 secondary outcomes
Objective response rate (ORR)
Time frame: Up to Week 16 post-treatment (with imaging assessments up to approximately 12 months or until disease progression)
disease control rate (DCR)
Time frame: Up to Week 16 post-treatment (with imaging assessments up to approximately 12 months or until disease progression)
Progression-free survival (PFS)
Time frame: Up to approximately 24 months.
overall survival (OS)
Time frame: Up to approximately 24 months.
duration of response (DOR)
Time frame: Up to approximately 24 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Biological/Vaccine in people with Advanced Gastrointestinal Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liu (+86 025-83106666, liuqin@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dose-limiting toxicities (DLTs) (time frame: From Week 1 through Week 16 of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.