RECRUITING

Autologous CAR-T Cells Targeting B7-H3 in PDAC

Conditions

Pancreas Cancer Relapse Resistant Cancer cellular therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this gene therapy research study is to test the safety and tolerability of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (iC9.CAR.B7-H3 T cells) in patients with pancreatic ductal adenocarcinoma that came back after receiving standard therapy for this cancer. The iC9.CAR.B7-H3 treatment is experimental and has not been approved by the Food and Drug Administration.

Official Title

A Phase I Study of Autologous CAR-T Cells Targeting the B7-H3 Antigen and Containing the Inducible Caspase 9 Safety Switch in Subjects With Refractory Pancreatic Ductal Adenocarcinoma (PDAC)

Quick Facts

Study Start:2024-07-18

Study Completion:2028-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06158139

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for releasing personal health information explained to, understood by, and signed by the subject or legally authorized representative. 2. Age ≥ 18 years at the time of consent. 3. Eastern Cooperative Oncology Group of 0-1 Performance Status) 4. Histological or cytological evidence/confirmation of pancreatic ductal adenocarcinoma. 5. Female subjects of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 6 months after study treatment discontinuation. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method or an intrauterine device that meets \< 1% failure rate for protection from pregnancy in the product label. 6. Male subjects with female partners must have had a prior vasectomy or agree to use an adequate method of contraception (i.e., double barrier method: condom plus spermicidal agent) starting with the first dose of study therapy through 3 months after the cell infusion therapy.	1. Subjects with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen. 2. Subject is not willing and able to comply with study procedures based on the judgment of the investigator.

Inclusion Criteria

Exclusion Criteria

1. Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for releasing personal health information explained to, understood by, and signed by the subject or legally authorized representative.
2. Age ≥ 18 years at the time of consent.
3. Eastern Cooperative Oncology Group of 0-1 Performance Status)
4. Histological or cytological evidence/confirmation of pancreatic ductal adenocarcinoma.
5. Female subjects of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 6 months after study treatment discontinuation. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method or an intrauterine device that meets \< 1% failure rate for protection from pregnancy in the product label.
6. Male subjects with female partners must have had a prior vasectomy or agree to use an adequate method of contraception (i.e., double barrier method: condom plus spermicidal agent) starting with the first dose of study therapy through 3 months after the cell infusion therapy.

1. Subjects with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
2. Subject is not willing and able to comply with study procedures based on the judgment of the investigator.

Contacts and Locations

Study Contact

Catherine Cheng

CONTACT

+1 919-445-4208

UNCImmunotherapy@med.unc.edu

Caroline Babinec

CONTACT

UNCImmunotherapy@med.unc.edu

Principal Investigator

Ashwin Somasundaram, MD

PRINCIPAL_INVESTIGATOR

UNC Lineberger Comprehensive Cancer Center

Study Locations (Sites)

University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599

United States

Collaborators and Investigators

Sponsor: UNC Lineberger Comprehensive Cancer Center

Ashwin Somasundaram, MD, PRINCIPAL_INVESTIGATOR, UNC Lineberger Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-18

Study Completion Date2028-06

Study Record Updates

Study Start Date2024-07-18

Study Completion Date2028-06

Terms related to this study

Keywords Provided by Researchers

cellular therapy

Additional Relevant MeSH Terms

Pancreas Cancer
Relapse
Resistant Cancer