Trials Sponsors Conditions Drugs Pricing

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
+6 more secondary outcomes

Interventions

CT041 autologous CAR T-cell injectionDrug

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.

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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:

Sponsors & Collaborators

Beijing GoBroad Hospital
Otherlead

Study Sites (1)

BeijingGoBroadH

Beijing, 100142, China

RECRUITING

Shen lin Shen linCONTACT

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

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

September 1, 2027

Estimated

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;
+14 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (11)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (11)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations