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Gastric AdenocarcinomaPhase 1/2NCT04581473

Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection

A Phase 1/2 study testing CT041 autologous CAR T-cell injection and Physician's Choice（Paclitaxel or Irinotecan or Apatinib or Anti-PD-1 antibody） in people with Gastric Adenocarcinoma and Pancreatic Cancer, run by CARsgen Therapeutics Co., Ltd. at 24 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

An open, multicenter, phase Ib/II study to evaluate the efficacy, safety and pharmacokinetics of CT041 autologous CAR T-cell injection in patients with advanced gastric/ gastroesophageal junction adenocarcinoma and pancreatic cancer Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
CT041 autologous CAR T-cell injection and Physician's Choice（Paclitaxel or Irinotecan or Apatinib or Anti-PD-1 antibody）
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
192 participants
Where
24 sitesChina
Study dates
23 Oct 2020to 30 Jun 2038
Phase
Phase 1/2
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

Who may be able to join

  • Be willing to participate in a clinical trial, be informed and sign inform consent; and be willing to follow and be able to complete all trial procedures;
  • Aged 18 to 75 years;
  • Phase Ib：Patients with pathologically diagnosed advanced gastric/ gastroesophageal junction adenocarcinoma who have failed at least 2 prior lines treatment; or patients with pathologically diagnosed advanced pancreatic cancer who have failed at least 1 prior line treatment ; Phase II：Patients with pathologically diagnosed advanced gastric/ gastroesophageal junction adenocarcinoma who have failed at least 2 prior lines treatment;
  • Phase Ib：Tumor tissue samples were positive for CLDN18.2 IHC staining； Phase II：Tumor tissue samples were positive for CLDN18.2 IHC staining and HER2 expression was negative;
  • Estimated life expectancy >12 weeks;
  • According to the RECIST 1.1, there is measurable tumor lesions;
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  • ECOG physical status score 0 ~ 1 at screening, within 24 hours prior to apheresis, and at baseline;
  • Sufficient venous access for mononuclear cell collection;
  • Unless otherwise specified, patients should meet the certain conditions prior to screening and pre-treatment and be allowed one week to retest if an abnormal laboratory test does not meet the criteria, and if the criteria are still not met, the screening is considered to have failed;
  • Female patients of childbearing age must undergo a serum pregnancy test at screening and prior to pretreatment and the results must be negative, and are willing to use a very effective and reliable method of contraception within 1 year after the last study treatment;
  • Men who have actively sexual intercourse with women with child-bearing potential, must agree to use barrier-based contraception if they have no vasectomy.

Who cannot join

  • Pregnant or lactating women;
  • HIV, Treponema pallidum, HCV serologically positive, EBV-DNA, CMV-DNA or 2019-ncov nucleic acid positive;
  • Any uncontrollable active infection, including but not limited to active tuberculosis, HBV infection;
  • The side effects caused by the previous treatment of the subjects did not return to CTCAE ≤1; except hair loss and other tolerable events determined by investigator;
  • Patients known to have active autoimmune diseases, including but not limited to psoriasis or rheumatoid arthritis, or other diseases requiring long-term immunosuppressive therapy;
  • Previously allergic to immunotherapy and related drugs,history of severe allergies, or allergic to components of CT041.
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  • Previously received any gene-modified cell therapies(including CAR-T, TCR-T);
  • Patients have brain metastasis or symptoms of brain metastasis;
  • Patients at high risk of hemorrhage or perforation;
  • Patients requiring anticoagulant therapy;
  • Patients requiring continuous anti-platelet therapy;
  • Patients with a history of organ transplantation or awaiting organ transplantation;
  • Patients who have undergone major surgery or significant trauma within 4 weeks prior to apheresis, or who are expected to undergo major surgery during the study;
  • Presence of other serious pre-existing medical conditions that may limit patient participation in the study;
  • The investigator assessed that the patient was unable or unwilling to comply with the requirements of the study protocol;
  • The patient has a central nervous system disease sign or an abnormal neurological test result with clinical significance;
  • The patient is currently suffered from or have suffered from other incurable malignant tumors within previous 3 years, except in situ cervical cancer or skin basal cell cancer.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

China24 sites

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • The First Hospital of Jilin University

    Changchun, Jilin

  • Sichuan Cancer Hospital

    Chengdu, Sichuan

  • West China Hospital, Sichuan University

    Chengdu, Sichuan

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hanzhou, Zhejiang

  • Harbin medical university Affiliated Cancer Hospital

    Harbin, Heilongjia

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui

  • Shandong Cancer Hospital

    Jinan, Shandong

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong

  • Ruijin Hospital, affiliated to Shanghai Jiaotong University, school of medicine

    Shanghai, Shanghai Municipality, 200025

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

  • Shanghai Zhongshan Hospital

    Shanghai, Shanghai Municipality

  • The First Hospital of China Medical University

    Shenyang, Liaoning

  • Peking University Shenzhen Hospital

    Shenzhen, Guangzhou

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

    Wuhan, Hubei

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu

  • Henan Tumor Hospital

    Zhengzhou, Henan

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

Other trials in China

About this study

Official title: An Open, Multicenter, Phase Ib/II Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection in Patients With Advanced Gastric/ Gastroesophageal Junction Adenocarcinoma and Pancreatic Cancer

An open, multicenter, phase Ib/II study to evaluate the efficacy, safety and pharmacokinetics of CT041 autologous CAR T-cell injection in patients with advanced gastric/ gastroesophageal junction adenocarcinoma and pancreatic cancer

Read the detailed description

This study is an open, multicenter, Phase Ib/II clinical trial evaluating chimeric antigen receptor-modified autologous T cells targeting Claudin18.2 (CLDN18.2) (CT041 autologous CAR T) in subjects with CLDN18.2 expression-positive, advanced gastric/esophagogastric conjugate adenocarcinoma that has failed at least 2 prior lines therapy and advanced pancreatic cancer that has failed at least 1 prior line therapy. The purpose is to evaluate the efficacy, safety and pharmacokinetics There are two stages in the study. Phase Ib stage is dose escalation and dose expansion study, and Phase II stage is to verify the efficacy and safety of CT041 treatment.

Being tested
CT041 autologous CAR T-cell injection, Physician's Choice（Paclitaxel or Irinotecan or Apatinib or Anti-PD-1 antibody）
Keywords
advanced solid tumors, Gastric Cancer, Pancreatic Cancer, Esophagogastric Junction Cancer, Claudin18.2, CLDN18.2, CAR T cell
Medical subject headings
Pancreatic Neoplasms, Stomach Neoplasms

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

    Also called CAR T-cell injection

    Up to 3 times CT041 autologous CAR T-cell injection infusion

  • Physician's Choice（Paclitaxel or Irinotecan or Apatinib or Anti-PD-1 antibody）Drug

    Also called Best support care(BSC)

    Physician's choice of any BSC listed above

Study groups in NCT04581473
Study groupRoleWhat they receive
CT041 autologous CAR T-cell injectionExperimentalTwo stages: Phase 1b: dose escalation and dose expansion; Phase 2: verify CT041 efficacy and safety
Receives: Drug: CT041 autologous CAR T-cell injection
Physician's ChoiceActive comparatorParticipants will receive physician's choice of treatment in Phase II
Receives: Drug: Physician's Choice（Paclitaxel or Irinotecan or Apatinib or Anti-PD-1 antibody）

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase Ib: Incidence of Treatment Related adverse events (AEs)

    Incidence of treatment related AEs, AEs of special interest and serious adverse events(SAEs).

    Measured: Up to 18 months

  2. Phase Ib: Identification of Maximum Tolerated Dose (MTD)

    Incidence of dose-limiting toxicities (DLTs)

    Measured: day1-day28

  3. Phase II: Progression-free survival (PFS), as assessed by IRC, of CT041 autologous CAR T-cell injection versus Physician's Choice

    Progression-free survival (PFS) was defined as the time from the date of randomization to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause.

    Measured: Up to 24 months

Secondary outcomes (10)

  1. Phase Ib: Objective Response Rate (ORR), as assessed by Investigators

    The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1.

    Measured: Up to 18 months

  2. Phase Ib: Progression-free survival (PFS), as assessed by Investigators

    Progression-free survival (PFS) was defined as the time from the date of first infusion of CT041 to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause.

    Measured: Up to 18 months

  3. Phase Ib：Overall survival (OS)

    Overall Survival (OS) was defined as the time from the date of first infusion of CT041 to the date of death due to any cause.

    Measured: Up to 18 months

  4. Phase Ib：Duration of response (DOR), as assessed by Investigators

    Duration of response (DOR) is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death.

    Measured: Up to 18 months

  5. Phase Ib：Disease control rate (DCR), as assessed by Investigators

    Disease control rate (DCR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR) or Stable disease (SD) based on RECIST version 1.1.

    Measured: Up to 18 months

  6. Phase II: Overall survival (OS) of CT041 autologous CAR T-cell injection versus Physician's Choice

    Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause.

    Measured: Up to 24 months

  7. Progression-free survival (PFS), as assessed by Investigators, of CT041 autologous CAR T-cell injection versus Physician's Choice

    Progression-free survival (PFS) was defined as the time from the date of randomization to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause.infusion

    Measured: Up to 24 months

  8. Phase II：Objective Response Rate (ORR), as assessed by IRC and by Investigators

    The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1.

    Measured: Up to 24 months

  9. Phase II: Duration of response (DOR), as assessed by IRC and by Investigators

    Duration of response (DOR) is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death.

    Measured: Up to 24 months

  10. Phase II: Disease control rate (DCR), as assessed by IRC and by Investigators

    Disease control rate (DCR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR) or Stable disease (SD) based on RECIST version 1.1.

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2020
  2. Study start23 Oct 2020
  3. Primary completion18 Oct 2024
  4. Study completion30 Jun 2038 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
192 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04581473
Sponsor's protocol ID
CT041-ST-01
Status last verified
Jun 2025
First submitted
24 Sep 2020
Last updated
5 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Qi C, Liu C, Peng Z, Zhang Y, Wei J, Qiu W, Zhang X, Pan H, Niu Z, Qiu M, Qin Y, Fang W, Ye F, Li N, Liu T, Liu A, Zhang X, Hu C, Zhang J, Cui J, Lin X, Wang S, Zhang J, Lin T, Qu X, Yuan X, Gong J, Li J, Gao W, Gai L, Wang Y, Yuan D, Li Z, Shen L. Claudin-18 isoform 2-specific CAR T-cell therapy (satri-cel) versus treatment of physician's choice for previously treated advanced gastric or gastro-oesophageal junction cancer (CT041-ST-01): a randomised, open-label, phase 2 trial. Lancet. 2025 Jun 7;405(10494):2049-2060. doi: 10.1016/S0140-6736(25)00860-8. Epub 2025 May 31.

    PubMed 40460847

  • Qi C, Zhang P, Liu C, Zhang J, Zhou J, Yuan J, Liu D, Zhang M, Gong J, Wang X, Li J, Zhang X, Li N, Peng X, Liu Z, Yuan D, Baffa R, Wang Y, Shen L. Safety and Efficacy of CT041 in Patients With Refractory Metastatic Pancreatic Cancer: A Pooled Analysis of Two Early-Phase Trials. J Clin Oncol. 2024 Jul 20;42(21):2565-2577. doi: 10.1200/JCO.23.02314. Epub 2024 May 24.

    PubMed 38788174

  • Qi C, Xie T, Zhou J, Wang X, Gong J, Zhang X, Li J, Yuan J, Liu C, Shen L. CT041 CAR T cell therapy for Claudin18.2-positive metastatic pancreatic cancer. J Hematol Oncol. 2023 Sep 9;16(1):102. doi: 10.1186/s13045-023-01491-9.

    PubMed 37689733

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CT041 autologous CAR T-cell injection and Physician's Choice（Paclitaxel or Irinotecan or Apatinib or Anti-PD-1 antibody） in people with Gastric Adenocarcinoma and Pancreatic Cancer, run by CARsgen Therapeutics Co., Ltd. at 24 sites 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 11 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites 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.

What does this combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase Ib: Incidence of Treatment Related adverse events (AEs) (time frame: Up to 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04581473, which also lists 3 linked publications.

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 5 Jun 2025.

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