To Evaluate the Efficacy of CT041 in Sequential Treatment After First-line Treatment of Advanced Gastric/Esophagogastric Junction Adenocarcinoma

NCT07179484 | Recruiting

• 1 other identifier: CT041-CG4011
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy of CT041 in sequential treatment after first-line treatment of advanced gastric/esophagogastric junction adenocarcinoma

Conditions

Gastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• To evaluate the efficacy of CT041 in sequential treatment after first-line treatment of advanced gastric/esophagogastric junction adenocarcinoma

  Progression-free survival (PFS)

  For 18 months

• peak CAR copy number (Cmax)

  peak CAR copy number (Cmax)

  12 months

Secondary Outcomes (11)

• Event-free survival (EFS)

  Approximately 24 months

• Overall survival (OS)

  Approximately 24 months

• Incidence, type, and severity of adverse events

  Signing ICF to CT041 infusion 15 years later

• Objective Response Rate（ORR）

  Approximately 24 months

• Disease control rate（DCR）

  Approximately 24 months

Interventions

CT041 autologous CAR T-cell injection DRUG

The planned dose of CT041 is 2.5×108 cells. The participants are recommended to receive only a single infusion or multiple infusions (up to 3 infusions) according to the safety and efficacy data of the participants per the investigator. The dose and method of re-infusion are the same as the first infusion. Lymphodepletion pretreatment should be given before re-infusion, and the requirements before lymphodepletion pretreatment and cell infusion should also be met before re-lymphodepletion pretreatment or re-infusion.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with unresectable locally advanced or metastatic gastric/esophagogastric junction adenocarcinoma who have not progressed after 12 weeks of first-line therapy.

You may qualify if:

• Individuals must meet all of the following criteria to be eligible for participation in this trial:
• Voluntarily participate in this trial; Fully understand and be informed of this trial and sign the informed consent form; Willing to follow and able to complete all trial procedures;
• Age 18-75 years (inclusive), male or female;
• Pathologically confirmed unresectable locally advanced or metastatic advanced gastric/esophagogastric junction (G/GEJ) adenocarcinoma;
• Immunohistochemical (IHC) staining of tumor tissue sample is CLDN18.2 positive, defined as staining intensity ≥ 2 + in at least 40% of tumor cells;
• Completed 12 weeks of first-line therapy according to clinical guidance, without disease progression as assessed by the investigator:
• Permitted treatment regimens include: fluoropyrimidine + platinum (± taxane) regimen chemotherapy, with or without immunotherapy or zolbetuximab. Other treatment regimens may be allowed to be included after discussion between the investigator and medical monitor of the collaborator; For the treatment regimen of every 2 weeks, 6 cycles should be completed, and for the treatment regimen of every 3 weeks, 4 cycles should be completed; According to the investigator's assessment and decision, participants without disease progression after at least 6 weeks of first-line treatment can undergo apheresis after meeting other eligibility criteria;
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (within 7 days prior to apheresis);
• Adequate venous access for apheresis and no other contraindications for apheresis.
• Laboratory test results within 7 days prior to apheresis should meet the following criteria (a repeat test within one week is allowed, if still not meeting the criteria, it will be considered a screening failure):
• Blood routine (without transfusion, platelet transfusion, colony-stimulating factor, platelet growth factor and other supportive treatment within 7 days before test, except recombinant human erythropoietin): absolute neutrophil count (ANC) ≥ 1.5×109/L, lymphocyte (LY) ≥ 0.5×109/L, platelet (PLT) ≥ 75×109/L, hemoglobin (Hb) ≥ 9.0 g/dL. The results of blood routine test within 24 hours before apheresis should also meet the above criteria.
• Blood chemistry: endogenous creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula), alanine aminotransferase (ALT) ≤ 2.5×upper limit of normal (ULN), aspartate aminotransferase (AST) ≤ 2.5×ULN, total bilirubin ≤ 2×ULN; serum amylase ≤ 2.0×ULN; alkaline phosphatase ≤ 2.5×ULN; AST, ALT and alkaline phosphatase ≤ 5 × ULN if there is bone metastasis or liver metastasis;
• Prothrombin time (PT) prolongation ≤ 4 seconds.
• Female participants of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and be willing to use highly effective and reliable contraception (\< 1% failure rate per year) for at least 12 months after receiving trial treatment and egg donation is absolutely prohibited during this period.
• Male participants who are sexually active with a female of childbearing potential, who have not had a vasectomy, must agree to practice abstinence or use highly effective and reliable contraception (failure rate \< 1% per year) for at least 12 months after receiving trial treatment and sperm donation is prohibited during this period.

You may not qualify if:

• Participants who meet any of the following criteria will be excluded from this trial:
• Presence of a known tumor tissue with high HER2 expression;
• Presence of gastrointestinal bleeding/perforation/obstruction or significant risk with these, including but not limited to anastomotic recurrence involving the full thickness of gastric wall, deep large ulcer, unstable/active ulcer, history of gastrointestinal bleeding/perforation/obstruction within 3 months (excluding those with surgical resection of the lesion leading to such event);
• Systemic anti-tumor treatment for G/GEJ adenocarcinoma within 21 days (or within 5 half-lives of the drug, whichever is shorter) prior to apheresis;
• Major surgery (excluding cataract surgery and other surgery requiring local anesthesia) or significant traumatic injury within 4 weeks prior to apheresis and has not adequately recovered from toxicity and/or complications;
• Previously received any genetic engineering modified cell therapy (such as CAR-T cells, TCR-T cells, etc.);
• Toxicities from previous treatment that have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 ≤ Grade 1, excluding alopecia, pigmentation, peripheral neuropathy, other events that, at the discretion of the investigator, do not affect the tolerability of the participant to the trial intervention, and laboratory abnormalities allowed in this trial.
• Note: Participants with non-clinically significant Grade 2 AE may be allowed to be included in the trial after discussion with medical monitor of the collaborator;
• Positive serology for human immunodeficiency virus (HIV), Treponema pallidum, or hepatitis C virus (HCV). Participants with positive HCV antibody but negative HCV RNA can be enrolled;
• Any active infection, including but not limited to active tuberculosis infection, active HBV infection (including hepatitis B surface antigen \[HBsAg\] positive, or hepatitis B core antibody \[HBcAb\] positive with HBV DNA above the lower limit of the trial center lab), and infection with other pathogens requiring systemic treatment. Participants receiving prophylactic anti-infective therapy may be enrolled at the discretion of the investigator;
• Participants with clinically significant thyroid dysfunction or severe complications that are not suitable for participation in this trial at the discretion of the investigator. Participants with stable thyroid function after treatment can be considered for enrollment;
• Received systemic corticosteroids within 14 days prior to apheresis. Recent or current use of inhaled or topical skin corticosteroids and physiologic dose replacement therapy may be enrolled;
• Need for long-term anticoagulation/antiplatelet therapy (e.g. Warfarin, heparin, rivaroxaban, aspirin, dipyridamole, clopidogrel, etc.). Participants receiving prophylactic anticoagulation to maintain patency of venous access devices may be enrolled;
• Allergy to fludarabine, cyclophosphamide, nab-paclitaxel, tocilizumab and other related drugs, or known allergy to components of CT041 cell infusion preparation (such as albumin or dimethyl sulfoxide \[DMSO\], etc.), or history of severe allergy in the past;
• Presence of known or suspected central nervous system metastases;

Sponsors & Collaborators

• Beijing GoBroad Hospital: lead

Study Sites (1)

BeijingGoBroadH

Beijing, 100142, China

RECRUITING

Central Study Contacts

Lifeng Zhang Lifeng Zhang

CONTACT

86-21-64501828; lifengzhang@carsgen.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 17, 2025
• Study Start: October 22, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)