Active, not recruitingNCT04404595Updated Jan 8, 2025

Claudin18.2 CAR-T (CT041) in Patients with Gastric, Pancreatic Cancer, or Other Specified Digestive Cancers

A Phase 1/2 interventional study of CT041 in Gastric Cancer and Pancreatic Cancer, sponsored by CARsgen Therapeutics Co., Ltd.. Active, not recruiting at 16 sites in 2 countries. Open to participants aged 18 Years to 76 Years. Per ClinicalTrials.gov, last updated 2025-01-08.

Sponsored by CARsgen Therapeutics Co., Ltd. · Phase 1/2, Interventional, and Treatment

From the registry’s dates

Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as active, not recruiting.

Phase: Phase 1/2
Study type: Interventional
Enrollment: 110
Allocation: Not applicable
Ages: 18 Years to 76 Years
Sex: All

Study summary

A Phase 1b/2, open label, multi-center, clinical study of Chimeric Antigen Receptor T Cells (CAR-T) targeting claudin18.2 in patients with advanced gastric, pancreatic or other specified digestive system cancers

Read the detailed description

This is an open label, multi-center, Phase 1b/2 clinical trial to evaluate the safety and efficacy of autologous claudin18.2 chimeric antigen receptor T-cell therapy in patients with advanced gastric, pancreatic or other specified digestive system cancers.

Following consent, patients must have tumor tissue evaluated by CLDN18.2 IHC assay. Patients meeting all eligibility criteria will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product (CT041). Following manufacture of the drug product, subjects will receive preconditioning prior to CT041 infusion. All subjects will be asked to continue to undergo long-term gene safety follow-up.

Conditions studied

Gastric Cancer
Pancreatic Cancer

Browse trials for

Pancreatic Neoplasms 3,235

Keywords

CAR-T

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's planned enrollment of 110 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

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Lead sponsor

CARsgen Therapeutics Co., Ltd. is the lead sponsor of 13 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 76 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patients are eligible for screening for potential inclusion in the study (* indicates inclusion criteria at Baseline (for subjects to be eligible for preconditioning)):

Voluntarily signed the ICF;
Age ≥ 18 and \< 76 years with pathologically/histologically confirmed diagnosis of adenocarcinoma of the stomach or gastroesophageal junction, referred to collectively as STAD, or pancreatic adenocarcinoma (PAAD);or biliary tract cancers (BTCs, including intrahepatic/extrahepatic cholangiocarcinoma and gallbladder cancer but not ampullary carcinoma);
Must have CLDN18.2-positive tumor expression as determined by the CLDN18.2 IHC assay;
Estimated life expectancy > 4 months*;
Failed or been intolerant of prior lines of systemic therapy:
1. For screening:
  - Leukapheresis can be performed for subjects with STAD who have progressed or were intolerant of at least 1 prior line of systemic therapy, or,
  - Leukapheresis can be performed for subjects with PAAD who are receiving first-line treatment, or,
  - Leukapheresis can be performed for subjects with BTC who are receiving first-line treatment.
2. Baseline*:
  - Subjects with STAD who have progressed or were intolerant of at least 2 prior lines of systemic therapy, or,
  - Subjects with PAAD who have progressed or were intolerant of at least 1 prior line of systemic therapy, or,
  - Subjects with BTC who have progressed or were intolerant of at least 1 prior line of systemic therapy. For subjects with CCA with who has FGFR2 fusions or rearrangements, or IDH1-mutant must have received FDA-approved target therapies.
At least 1 measurable lesion per RECIST 1.1*;
ECOG performance status of 0 or 1*;
Sufficient venous access for leukapheresis collection and no other contraindications to leukapheresis;
Patients should have adequate CBC counts, renal and hepatic functions*;
Women of childbearing age must undergo a serum pregnancy test with negative results before screening and infusion and be willing to use effective and reliable method of contraception*;
Men must be willing to use effective and reliable method of contraception for at least 12-months after T-cell infusion*;
Sufficient nutritional status.

Exclusion Criteria for screening (* indicates exclusion criteria for baseline as well):

Pregnant or lactating women*;
HIV, active hepatitis C virus (HCV), active hepatitis B virus (HBV), or active syphilis infection;
Any active infection requiring systemic treatment*;
AEs from previous treatment that have not recovered*;
Patients who have clinically significant thyroid dysfunction;
Patients allergic to any drugs of the preconditioning regimen, tocilizumab, dimethyl sulfoxide (DMSO), or CT041 CAR-CLDN18.2 T-cell;
Patients who have received:
1. prior cellular therapy such as (CAR T, TCR, tumor-infiltrating lymphocytes) within one year.
2. organ transplantation.
3. previous anti-claudin18.2 CAR T-cell therapy, mRNA-based cancer immunotherapy, or bispecific T cell engager.
Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression;
Patients with heavy tumor burdens;
Unstable/active ulcer, anastomotic recurrence with full-thickness tumor infiltration or tumor involving any major vessels, digestive tract bleeding, or recent digestive surgery that may have increased risk of bleeding*;
Patients who have a history of esophageal or gastric resection plus current evidence of locally recurrent tumor that involves any major blood vessels or that has evidence of recent bleeding or perforation*;
Patients requiring anticoagulant therapy such as warfarin or heparin;
Patients requiring long-term antiplatelet therapy;
Use of prednisone >/= 10mg daily or other equivalent steroids within 14 days before leukapheresis or preconditioning*;
Anticancer treatment within approximately 2 weeks prior to leukapheresis or preconditioning*;
Major surgery less than 1 week prior to leukapheresis or 3 weeks prior to preconditioning*;
Patients who have clinically significant cardiac conditions that researchers believe that participating in this clinical trial may endanger the health of the patients*;
Inadequate pulmonary function*;
Patients known to have active autoimmune diseases;
Patients with second malignancies;
Patients have significant neurologic disorders;
Patients are unable or unwilling to comply with the requirements of clinical trial.
Additional exclusion criteria solely for baseline (prior to conditioning regimen):
Fever > 38.0°C;
Active illness or existing toxicity that would place the subject at undue risk;
Abrupt deterioration of clinical status or condition;
Subjects who have received a live attenuated vaccine 4 weeks before preconditioning.

Inclusion Criteria Before Infusion: There are no inclusion criteria at this timepoint.

Exclusion criteria

Exclusion Criteria Before Infusion:

Patients who have clinically significant cardiac conditions that researchers believe that participating in this clinical trial may endanger the health of the patients;
Inadequate pulmonary function;
Active infection requiring systemic therapy or causing fever within 7 days prior to investigational infusion;
Active illness or toxicity that would place the subject at undue risk;
Abrupt deterioration of clinical status or condition;
New or worsening Grade ≥ 3 non-hematologic toxicities.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 110 participants (estimated)

Study arms

Experimental
anti-claudin18.2 chimeric antigen receptor T-cell therapy
Phase 1b will include two parts, dose escalation phase (Cohort A) followed by a dose expansion phase (Cohort B). Phase 2 (Cohort C) will evaluate the chosen dose in patients with advanced gastric cancer.
Biological: CT041

Interventions

BiologicalCT041
treatment with anti-claudin18.2 chimeric antigen receptor T-cell infusion

What researchers measure

Primary outcomes

Phase 1b (Cohort A): Evaluate the safety and tolerability of CAR-CLDN18.2 T-cell therapy (CT041) in subjects with specified advanced digestive system cancers (STAD, PAAD, or BTC).
Incidence of adverse events (AEs), AEs of special interest (cytokine release syndrome \[CRS\], neurotoxicity, secondary malignancy), serious adverse events (SAEs).
Time frame: up to year 15
Phase 1b (Cohort A): Identify the recommended Phase 2 dose (RP2D) of CT041 therapy in subjects with advanced STAD, PAAD, or BTC.
Incidence of dose-limiting toxicities (DLTs)
Time frame: day 0 - day 28
Phase 1b (Cohort A): Identify the maximum tolerated dose (MTD) or maximum administered dose (MAD) of CT041 therapy in subjects with STAD, PAAD, or BTC.
The highest dose below the dose where the escalation was stopped when the frequency or severity of DLTs exceeds predefined safety criteria.
Time frame: day 0 - day 28
Phase 1b (Cohort B): Determine the efficacy of CT041 by ORR in subjects with advanced STAD, PAAD, or BTC.
Objective response rate by IRC assessment (RECIST v1.1)
Time frame: up to year 15
Phase 2 (Cohort C): Determine the efficacy of CT041 by ORR in subjects with advanced STAD treated at the RP2D.
Objective response rate by IRC assessment (RECIST v1.1)
Time frame: up to year 15

Secondary outcomes

Phase 1b/2: Objective Response Rate (ORR) per investigator assessment
Rate of subjects experiencing an objective response (a binary variable indicating whether each subject experienced a ≥ partial response \[PR\] by Response Evaluation Criteria in Solid Tumors, version 1.1 \[RECIST 1.1\]), as determined by investigator assessment.
Time frame: up to year 15
Phase 1b (Cohort A): Duration of Response
Duration of time from first response to progression of disease as determined by investigator
Time frame: up to year 15
Phase 1b (Cohort A): Time to Progression
Duration of time in months from the date of CT041 infusion until disease progression, excluding deaths as determined by investigator.
Time frame: up to year 15
Phase 1b (Cohort A): Disease Control Rate
The incidence of a BOR of CR, PR, or SD based on investigator assessments using RECIST 1.1 criteria.
Time frame: up to year 15
Phase 1b (Cohort A): Progression free survival
The time in months from the date of CT041 infusion to the earliest date of disease progression or death due to any cause as determined by investigator.
Time frame: up to year 15
Phase 1b (Cohort B): Evaluate the safety and tolerability of CAR-CLDN18.2 T-cell therapy (CT041) in subjects with specified advanced digestive system cancers (STAD, PAAD, or BTC).
Incidence of adverse events (AEs), AEs of special interest (cytokine release syndrome \[CRS\], neurotoxicity, secondary malignancy), serious adverse events (SAEs).
Time frame: up to year 15
Phase 2 (Cohort C): Evaluate the safety and tolerability of CAR-CLDN18.2 T-cell therapy (CT041) in subjects with advanced STAD.
Incidence of adverse events (AEs), AEs of special interest (cytokine release syndrome \[CRS\], neurotoxicity, secondary malignancy), serious adverse events (SAEs).
Time frame: up to year 15
Phase 1b(Cohort B)/2: Duration of Response
Duration of time from first response to progression of disease as determined by investigator and IRC assessment.
Time frame: up to year 15
Phase 1b(Cohort B)/2: Time to Progression
Duration of time in months from the date of CT041 infusion until disease progression, excluding deaths as determined by investigator and IRC assessment.
Time frame: up to year 15
Phase 1b(Cohort B)/2: Disease Control Rate
The incidence of a BOR of CR, PR, or SD based on investigator and IRC assessments using RECIST 1.1 criteria.
Time frame: up to year 15
Phase 1b(Cohort B)/2: Progression free survival
The time in months from the date of CT041 infusion to the earlier date of disease progression or death due to any cause as determined by investigator and IRC assessment.
Time frame: up to year 15
Phase 1b/2: Overall survival
The time in months from the date of CT041 infusion until the date of death by any cause.
Time frame: up to year 15
Phase 1b/2: Utilization of Hospital Resources
Total days of hospitalization, including ICU days, during \& after CT041 infusion as described below: * Infusion-related hospital re-admission within 3 months after infusion. * The number and percentages of subjects, and the number of hospitalizations due to non-infusion reasons. * All-cause re-admission within 3 months after infusion, and from infusion to data cutoff date among those who required rehospitalization * Duration of hospitalization in intensive care
Time frame: Day 0 to 3 months
Phase 1b(Cohort B)/2: PK and bio-distribution of CT041
CAR transgene copy number, peak value, AUC, in vivo persistence.
Time frame: Baseline - month 18
Phase 1b(Cohort B)/2: Health-related Quality of Life (HRQoL) in STAD patients (Cohorts B & C)
* Change from baseline in HRQoL as measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30. * Change from baseline in HRQoL as measured by EORTC QLQ-OG25.
Time frame: Baseline - month 18
Phase 1b(Cohort B)/2: CLDN18.2 ICH Assay Performance
* Association of CLDN18.2 expression level versus tumor response * Association of CLDN18.2 expression versus clinical disease characteristics
Time frame: Baseline - month 18
Phase 1b(Cohort B)/2: Cytokine expression level in blood after CT041 infusion
Evaluate cytokine expression level in blood after CT041 infusion.
Time frame: Baseline - week 20
Phase 1b (Cohort B)/2: Anti-CT041 drug antibodies
Number of subjects with anti-CT041 drug antibodies
Time frame: Baseline - month 12
Phase 1b (Cohort B)/2: CT041 product characteristics
Association of CT041 product characteristics with clinical safety/efficacy/PK
Time frame: Baseline - month 18
Phase 1b (Cohort B)/2: Concordance analysis
Concordance analysis of ORR of IRC assessment vs investigator assessment.
Time frame: up to year 15

Study locations

16 sites

City of Hope
Duarte, California 91010, United States
University of Southern California
Los Angeles, California 90089, United States
UCSD
San Diego, California 92093, United States
UCSF
San Francisco, California 94143, United States
Moffitt Cancer Center
Tampa, Florida 33612, United States
University of Kansas Cancer Center
Kansas City, Kansas 66160, United States
Karmanos Cancer Center
Detroit, Michigan 48201, United States
Mayo Cancer Hospital
Rochester, Minnesota 55905, United States
Northwell Cancer Institute
New Hyde Park, New York 11042, United States
The Mount Sinai Hospital
New York, New York 10029, United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065, United States
Ohio State University
Columbus, Ohio 43210, United States
TX Oncology-Baylor Charles Sammons Cancer Center
Dallas, Texas 75246, United States
MD Anderson Cancer Center
Houston, Texas 77030, United States
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin 53226, United States
Princess Margaret Hospital
Toronto, Ontario M5GH 2C1, Canada

References and documents

Publications

Botta GP, Chao J, Ma H, Hahn M, Sierra G, Jia J, Hendrix AY, Nolte Fong JV, Ween A, Vu P, Miller A, Choi M, Heyman B, Daniels GA, Kaufman D, Jamieson C, Li Z, Cohen E. Metastatic gastric cancer target lesion complete response with Claudin18.2-CAR T cells. J Immunother Cancer. 2024 Feb 5;12(2):e007927. doi: 10.1136/jitc-2023-007927. PubMed 38316518 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04404595
Lead sponsor: CARsgen Therapeutics Co., Ltd.
Responsible party: Sponsor
First posted: May 27, 2020
Start date: Oct 23, 2020
Primary completion: Jun 1, 2025 (estimated)
Completion: Sep 1, 2035 (estimated)
Last update: Jan 8, 2025

Study contacts

Harry H Yoon, MD

principal investigator · Mayo

Dae Won Kim, MD

principal investigator · Moffitt

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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