CT041 for Malignant Neoplasm of Pancreas

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Malignant Neoplasm of Pancreas+2 More
CT041 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Malignant Neoplasm of Pancreas
  • Malignant Neoplasm of Stomach

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Malignant Neoplasm of Pancreas

Study Objectives

5 Primary · 18 Secondary · Reporting Duration: Baseline - month 18

Baseline - month 18
Phase 1b/2: CLDN18.2 ICH Assay Performance
Phase 1b/2: Health-related Quality of Life (HRQoL)
Phase 1b/2: PK and bio-distribution of CT041
Month 18
Phase 1b/2: Anti-CT041 drug antibodies
Month 6
Phase 1b/2: Cytokine expression level in blood after CT041 infusion
Day 28
Phase 1b: Identification of Maximum Tolerated Dose (MTD) & incidence of Dose-limiting Toxicities (DLTs)
Month 18
Disease Control Rate
Duration of Response
Identification of Maximum Tolerated Dose (MTD)
Incidence of Treatment Related adverse events (AEs)
Objective Response Rate (ORR)
Overall survival
Progression free survival
Time to Progression
up to 18 mos
Phase 1b/2: Disease Control Rate
Phase 1b/2: Duration of Response
Phase 1b/2: Overall survival
Phase 1b/2: Progression free survival
Phase 1b/2: Utilization of Hospital Resources
Phase 1b: Incidence of Treatment Related adverse events (AEs)
Phase 1b: Objective Response Rate (ORR) per local assessment
Phase 2: Incidence of Treatment Related adverse events (AEs)
Phase 2: Objective Response Rate (ORR) per independent central read

Trial Safety

Safety Progress

1 of 3

Other trials for Malignant Neoplasm of Pancreas

Trial Design

1 Treatment Group

anti-claudin18.2 chimeric antigen receptor T-cell therapy
1 of 1
Experimental Treatment

110 Total Participants · 1 Treatment Group

Primary Treatment: CT041 · No Placebo Group · Phase 1 & 2

anti-claudin18.2 chimeric antigen receptor T-cell therapy
Biological
Experimental Group · 1 Intervention: CT041 · Intervention Types: Biological

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline - month 18

Who is running the clinical trial?

Carsgen Therapeutics, Ltd.Lead Sponsor
7 Previous Clinical Trials
715 Total Patients Enrolled
1 Trials studying Malignant Neoplasm of Pancreas
192 Patients Enrolled for Malignant Neoplasm of Pancreas
CARsgen Therapeutics Co., Ltd.Lead Sponsor
19 Previous Clinical Trials
978 Total Patients Enrolled
2 Trials studying Malignant Neoplasm of Pancreas
255 Patients Enrolled for Malignant Neoplasm of Pancreas
Dae Won Kim, MDPrincipal InvestigatorMoffitt
1 Previous Clinical Trials
Harry H Yoon, MDPrincipal InvestigatorMayo

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have no signs or symptoms of cancer.
Venous access is sufficient for leukapheresis collection.
You have a tumor that is positive for CLDN18.2 as determined by the CLDN18.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 31st, 2021

Last Reviewed: October 16th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.