Study on Claudin18.2 CAR-T Therapy for Patients with Advanced Gastric, Pancreatic, or Other Digestive Cancers

Sponsor: CARsgen Therapeutics Co., Ltd.

Sponsor score: 0

ClinicalTrials ID:NCT04404595

This clinical trial is testing a new treatment using CAR-T cells that target a specific protein, Claudin18.2, in patients with advanced gastric, pancreatic, or other digestive system cancers. The study aims to evaluate the safety and effectiveness of this therapy.

Patient Parameters

Program Overview

This study is exploring a new treatment called Claudin18.2 CAR-T cell therapy for patients with advanced gastric, pancreatic, or other specified digestive system cancers. The treatment involves using a patient's own immune cells, which are modified in the lab to target cancer cells with the Claudin18.2 protein. The main goals are to assess the safety of this treatment and to see if it can help shrink tumors in adults aged 18 to 75 who have these types of cancers. Participants will undergo several procedures, including blood collection, cell modification, and infusion of the modified cells, followed by long-term monitoring to ensure safety.

Description

This clinical trial is designed to test the safety and effectiveness of a new treatment called Claudin18.2 CAR-T cell therapy in patients with advanced gastric, pancreatic, or other digestive system cancers. The study involves several steps:

  1. Screening and Consent: Patients will first provide consent to participate and have their tumor tissue tested for the presence of the Claudin18.2 protein.

  2. Cell Collection: Eligible patients will undergo a procedure called leukapheresis to collect their immune cells, which will be modified in the lab to target cancer cells.

  3. Cell Modification and Infusion: The collected cells are genetically modified to become Claudin18.2 CAR-T cells. After a preparation phase, these modified cells are infused back into the patient.

  4. Follow-Up: Patients will be monitored for safety and effectiveness of the treatment, with regular check-ups and tests to track their health and response to the therapy.

The study aims to determine if this new approach can safely and effectively treat cancers that express the Claudin18.2 protein, offering a potential new option for patients with limited treatment choices.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 to 75 with a confirmed diagnosis of advanced gastric, pancreatic, or certain other digestive system cancers.
  • Tumors must express the Claudin18.2 protein.
  • Life expectancy of more than 4 months.
  • Have not responded to or cannot tolerate previous cancer treatments.
  • At least one measurable tumor.
  • Good overall health with a performance status of 0 or 1.
  • Able to undergo the cell collection procedure.
  • Adequate blood counts and organ function.
  • Women of childbearing age must test negative for pregnancy and agree to use contraception.
  • Men must agree to use contraception for 12 months after treatment.
  • Sufficient nutritional status.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Active infections like HIV, hepatitis B or C, or syphilis.
  • Unresolved side effects from previous treatments.
  • Significant thyroid problems or allergies to study drugs.
  • Previous treatments with certain types of cell therapies or organ transplants.
  • Untreated brain or spinal cord cancer spread.
  • Large tumor burdens or recent digestive surgery with bleeding risk.
  • Need for blood thinners or long-term antiplatelet therapy.
  • Recent use of certain steroids or cancer treatments.
  • Major surgery within the last few weeks.
  • Significant heart, lung, or autoimmune conditions.
  • Other active cancers or serious neurological disorders.
  • Unable or unwilling to follow study requirements.

Locations

FACILITYZIPCITYSTATE
City of Hope91010DuarteCalifornia
University of Southern California90089Los AngelesCalifornia
UCSD92093San DiegoCalifornia
UCSF94143San FranciscoCalifornia
Moffitt Cancer Center33612TampaFlorida
University of Kansas Cancer Center66160Kansas CityKansas
Karmanos Cancer Center48201DetroitMichigan
Mayo Cancer Hospital55905RochesterMinnesota
Northwell Cancer Institute11042New Hyde ParkNew York
The Mount Sinai Hospital10029New YorkNew York

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