Gastroesophageal Junction AdenocarcinomaNCT07179484
To Evaluate the Efficacy of CT041 in Sequential Treatment After First-line Treatment of Advanced Gastric/Esophagogastric Junction Adenocarcinoma
An observational study of Gastroesophageal Junction Adenocarcinoma, run by Beijing GoBroad Hospital at 1 site in China.
Trial summary
To evaluate the efficacy of CT041 in sequential treatment after first-line treatment of advanced gastric/esophagogastric junction adenocarcinoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- CT041 autologous CAR T-cell injection
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 22 Oct 2025to 1 Sep 2028
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with unresectable locally advanced or metastatic gastric/esophagogastric junction adenocarcinoma who have not progressed after 12 weeks of first-line therapy.
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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);
- Participants who have previously received any anti-tumor therapy other than the first-line treatment regimen for G/GEJ adenocarcinoma allowed in this trial (see Item 5 of the inclusion criteria), including any other systemic anti-tumor drugs, any radiotherapy or interventional therapy, etc.;
- 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;
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- 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;
- Presence of central type or extensive lung metastasis, or extensive liver metastasis, or extensive bone metastasis;
- Abdominal/pleural effusion with clinical symptoms or requiring special treatment, such as repeated drainage, abdominal/pleural drug perfusion, etc. (participants with small amount of ascites/pleural effusion that can be detected by imaging examination can be considered for enrollment);
- Participants who have previously received organ transplantation or allogeneic hematopoietic stem cell transplantation, or are awaiting organ transplantation;
- Vaccination with live or live attenuated vaccines within 4 weeks prior to apheresis or planned during the trial;
- Presence of active autoimmune diseases, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, autoimmune hepatitis, interstitial lung disease, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, multiple sclerosis, glomerulonephritis, etc.; And currently receiving or requiring long-term immunosuppressant therapy during the trial;
- Presence of any of the following cardiovascular diseases: uncontrolled congestive heart failure (New York Heart Association [NYHA] Class III-IV), cardiac dysfunction [left ventricular ejection fraction (LVEF) < 50%], myocardial infarction within the last 6 months, poorly controlled arrhythmia, unstable angina, poorly controlled hypertension (blood pressure > 160 mmHg/100 mmHg), hypotension that is symptomatic or requires vasopressor medication, and other diseases or test abnormalities that are deemed inappropriate for participation in the trial by the investigator. Discussion with medical monitor of the collaborator is recommended if necessary;
- Pulmonary diseases that are not suitable for participation in this trial as assessed by the investigator, including but not limited to: chronic obstructive pulmonary disease, pulmonary embolism, interstitial lung disease, clinically significant abnormal pulmonary function test, etc. Discussion with medical monitor of the collaborator is recommended if necessary;
- Oxygen saturation (SaO2) ≤ 95% without oxygen inhalation (finger oxygen detection method is accepted);
- Presence of clinically significant neurological disorders, psychiatric disorders or abnormal neurological examination results;
- As assessed by the investigator, the participant has poor glycemic control under adequate treatment or has experienced relevant complications;
- Presence of any clinicopathological features, other diseases, metabolic disorders, signs or abnormal examination results that prohibit the trial intervention, affect the interpretation of the results, preclude CT041 infusion, or are at high risk of serious complications after infusion, and are assessed as unsuitable for participation by the investigator;
- Uncured malignant tumor other than G/GEJ cancer in the past 5 years or at the same time; Except for adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix and other malignancies with very low risk of metastasis or death;
- Pregnant or lactating females;
- Participants who are unable or unwilling to comply with the requirements of the clinical trial protocol as assessed by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
BeijingGoBroadH
Beijing, 100142
Shen lin Shen lin
About this study
Official title: An Open-label, Single-arm, Multicenter Phase Ib Clinical Trial Evaluating the Efficacy, Safety, and Cellular Metabolism Kinetics of CT041 Autologous CAR-T Cell Injection as a Sequential Therapy Following First-line Treatment for Advanced Gastric/Gastroesophageal Junction Adenocarcinoma.
To evaluate the efficacy of CT041 in sequential treatment after first-line treatment of advanced gastric/esophagogastric junction adenocarcinoma
- Conditions
- Gastroesophageal Junction Adenocarcinoma
- Being tested
- CT041 autologous CAR T-cell injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of CT041 in sequential treatment after first-line treatment of advanced gastric/esophagogastric junction adenocarcinoma
Progression-free survival (PFS)
Measured: For 18 months
peak CAR copy number (Cmax)
peak CAR copy number (Cmax)
Measured: 12 months
Secondary outcomes (11)
Event-free survival (EFS)
Event-free survival (EFS)
Measured: Approximately 24 months
Overall survival (OS)
Overall survival (OS)
Measured: Approximately 24 months
Incidence, type, and severity of adverse events
Incidence, type and severity of adverse events, including:
Adverse events (AEs); Adverse events of special interest (AESIs); Serious Adverse Events (SAEs), etc.
Measured: Signing ICF to CT041 infusion 15 years later
Objective Response Rate（ORR）
Objective Response Rate（ORR）
Measured: Approximately 24 months
Disease control rate（DCR）
Disease control rate（DCR）
Measured: Approximately 24 months
Duration of response (DOR)
Duration of response (DOR)
Measured: Approximately 24 months
Duration of disease control (DDC)
Duration of disease control (DDC)
Measured: Approximately 24 months
Progression-free survival-1 (PFS-1)
Progression-free survival-1 (PFS-1)
Measured: Approximately 24 months
Overall survival-1 (OS-1)
Overall survival-1 (OS-1)
Measured: Approximately 24 months
CAR copy number, time to peak CAR copy number (Tmax)
CAR copy number, time to peak CAR copy number (Tmax)
Measured: Approximately 12 months
area under the curve (AUC) and cell persistence (Tlast) after CT041 infusion
area under the curve (AUC) and cell persistence (Tlast) after CT041 infusion
Measured: Approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start22 Oct 2025 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Junction AdenocarcinomaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing GoBroad Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07179484
- Sponsor's protocol ID
- CT041-CG4011
- Status last verified
- Sep 2025
- First submitted
- 28 Aug 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm, Multicenter Phase Ib Clinical Trial Evaluating the Efficacy, Safety, and Cellular Metabolism Kinetics of CT041 Autologous CAR-T Cell Injection as a Sequential Therapy Following First-line Treatment for Advanced Gastric/Gastroesophageal Junction Adenocarcinoma.
- ClinicalTrials.gov ID
- NCT07179484
- Acronym / sponsor ID
- CT041-CG4011
- Conditions
- Gastroesophageal Junction Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Beijing GoBroad HospitalUniversity, hospital or other
- Study start
- 22 Oct 2025 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 17 Sep 2025 (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.
To evaluate the efficacy of CT041 in sequential treatment after first-line treatment of advanced gastric/esophagogastric junction adenocarcinoma
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with unresectable locally advanced or metastatic gastric/esophagogastric junction adenocarcinoma who have not progressed after 12 weeks of first-line therapy.
Key inclusion criteria (15 listed)
- 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;
Key exclusion criteria (30 listed)
- 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);
- Participants who have previously received any anti-tumor therapy other than the first-line treatment regimen for G/GEJ adenocarcinoma allowed in this trial (see Item 5 of the inclusion criteria), including any other systemic anti-tumor drugs, any radiotherapy or interventional therapy, etc.;
- 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;
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 |
|---|---|---|
| CT041 autologous CAR T-cell injectionThe 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. | Drug | – |
Primary outcome
To evaluate the efficacy of CT041 in sequential treatment after first-line treatment of advanced gastric/esophagogastric junction adenocarcinoma
Time frame: For 18 months
Progression-free survival (PFS)
peak CAR copy number (Cmax)
Time frame: 12 months
peak CAR copy number (Cmax)
11 secondary outcomes
Event-free survival (EFS)
Time frame: Approximately 24 months
Overall survival (OS)
Time frame: Approximately 24 months
Incidence, type, and severity of adverse events
Time frame: Signing ICF to CT041 infusion 15 years later
Objective Response Rate（ORR）
Time frame: Approximately 24 months
Disease control rate（DCR）
Time frame: Approximately 24 months
Duration of response (DOR)
Time frame: Approximately 24 months
Duration of disease control (DDC)
Time frame: Approximately 24 months
Progression-free survival-1 (PFS-1)
Time frame: Approximately 24 months
Overall survival-1 (OS-1)
Time frame: Approximately 24 months
CAR copy number, time to peak CAR copy number (Tmax)
Time frame: Approximately 12 months
area under the curve (AUC) and cell persistence (Tlast) after CT041 infusion
Time frame: Approximately 12 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 1 Oct 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Junction Adenocarcinoma, run by Beijing GoBroad Hospital at 1 site in China.
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 30 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: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 Lifeng Zhang Lifeng Zhang (86-21-64501828, lifengzhang@carsgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of CT041 in sequential treatment after first-line treatment of advanced gastric/esophagogastric junction adenocarcinoma (time frame: For 18 months). The study lists 2 primary outcomes in all. 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 1 Oct 2025.