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CAR T-cell Therapy

CT041 CAR-T Therapy for Stomach and Pancreatic Cancer

Phase 1 & 2
Waitlist Available
Led By Harry H Yoon, MD
Research Sponsored by Carsgen Therapeutics, Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status of 0 or 1
Failed or been intolerant of prior lines of systemic therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline - month 18
Awards & highlights

Study Summary

This trial is testing a new treatment for stomach, pancreatic, and other digestive system cancers using CAR-T cells, which are immune cells that are genetically modified to target and kill cancer cells.

Who is the study for?
This trial is for adults aged 18-75 with advanced gastric or pancreatic cancer, who have tried other treatments without success. They must not be pregnant, have HIV/HBV/HCV, uncontrolled infections, significant heart/lung/neurological disorders, autoimmune diseases, a second cancer besides STAD/PAAD or previous cell therapies/transplants.Check my eligibility
What is being tested?
The study tests CT041 CAR-T cells targeting claudin18.2 in patients with specific digestive cancers. It's an early-phase trial to assess safety and effectiveness of this therapy in those whose tumors express CLDN18.2 and who've failed standard treatments.See study design
What are the potential side effects?
Potential side effects may include immune reactions due to the modified T-cells attacking normal cells along with the cancerous ones; symptoms could range from fever and fatigue to more serious conditions affecting different organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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I have not responded well to previous cancer treatments.
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I can undergo leukapheresis with no issues.
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I am not pregnant and agree to use birth control during the study.
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I am between 18 and 75 years old with a confirmed diagnosis of stomach or pancreatic cancer.
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My tumor is CLDN18.2 positive.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline - month 18
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline - month 18 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1b: Identification of Maximum Tolerated Dose (MTD) & incidence of Dose-limiting Toxicities (DLTs)
Phase 1b: Incidence of Treatment Related adverse events (AEs)
Phase 2: Objective Response Rate (ORR) per independent central read
Secondary outcome measures
Phase 1b/2: Anti-CT041 drug antibodies
Phase 1b/2: CLDN18.2 ICH Assay Performance
Phase 1b/2: Cytokine expression level in blood after CT041 infusion
+9 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: anti-claudin18.2 chimeric antigen receptor T-cell therapyExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Carsgen Therapeutics, Ltd.Lead Sponsor
7 Previous Clinical Trials
529 Total Patients Enrolled
CARsgen Therapeutics Co., Ltd.Lead Sponsor
24 Previous Clinical Trials
1,014 Total Patients Enrolled
Harry H Yoon, MDPrincipal InvestigatorMayo

Media Library

CT041 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04404595 — Phase 1 & 2
Stomach Cancer Research Study Groups: anti-claudin18.2 chimeric antigen receptor T-cell therapy
Stomach Cancer Clinical Trial 2023: CT041 Highlights & Side Effects. Trial Name: NCT04404595 — Phase 1 & 2
CT041 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04404595 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who might be the ideal candidates for enrollment in this clinical trial?

"This clinical trial seeks 110 individuals, aged 18 to 76 years old, who have been clinically diagnosed with malignant neoplasm of the pancreas. Other prerequisites include being able to voluntarily sign an Informed Consent Form (ICF), having failed or experienced intolerance from prior systemic therapies and expectancy for survival exceeding 4 months. The participants should also be ECOG performance status 0-1; possess sufficient venous access for leukapheresis collection and normal CBC counts, renal functions and liver functioning. For female candidates within childbearing age group must obtain a negative serum pregnancy test result before screening/infusion and agree to use reliable"

Answered by AI

Are any participants being accepted for this research initiative presently?

"Affirmative, according to clinicaltrials.gov, the trial is still recruiting patients since it was first published in October 2020 and last updated on August 8th 2022. 110 participants are needed from 21 sites across the country."

Answered by AI

What is the highest capacity for enrollment in this clinical trial?

"In order to fulfil the scientific requirements of this trial, 110 qualified participants are needed. Patients can join from various locations around the United States such as Mayo Clinic - AZ in Phoenix and The Mount Sinai Hospital in New york City."

Answered by AI

What is the major goal of this clinical trial?

"During the 28-day period of this clinical trial, its primary outcome will be to measure Treatment Related Adverse Events (AEs). Secondary outcomes include a Rate of subjects experiencing >/= Partial Response per RECIST 1.1 as determined by investigator; Persistence of CAR transgene copy number in PK and bio-distribution profiles; and Objective Response Rate (ORR), which is measured through the rate of subjects exhibiting >/= Partial Response per RECIST 1.1 as determined by Investigator."

Answered by AI

How many sites have been designated to conduct this research?

"At this moment in time, 21 medical facilities are running the trial. These sites can be found in Phoenix, New york and New Hyde Park amongst other cities. To reduce travel needs it is suggested that participants select a location close to them if they do join."

Answered by AI

Does this experiment include geriatric individuals?

"Participants must be aged between 18 and 76 to take part in this research."

Answered by AI

Who else is applying?

What site did they apply to?
Memorial Sloan Kettering Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

to find better treatment options.
PatientReceived 1 prior treatment
~26 spots leftby Jun 2025