Using CAR-T cells to target B7-H3 in pancreatic cancer
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)
This study is testing a new treatment using specially modified immune cells to see if they can safely help people with pancreatic cancer that has come back after other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 27 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chimeric antigen receptor, CAR-T |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06158139 on ClinicalTrials.gov |
What this trial studies
This phase 1 clinical trial aims to evaluate the safety and tolerability of a novel treatment involving autologous T lymphocyte chimeric antigen receptor (CAR) cells that target the B7-H3 antigen in patients with pancreatic ductal adenocarcinoma that has relapsed after standard therapy. The study will utilize a dose escalation approach to determine the maximum tolerated dose of iC9.CAR.B7-H3 T cells, which are designed to enhance the body's immune response against cancer cells. Participants will receive infusions of these engineered T cells, and the study will monitor their safety and effectiveness in combating the disease.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed pancreatic ductal adenocarcinoma that has not responded to standard treatments.
Not a fit: Patients with non-refractory pancreatic cancer or those who do not meet the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with resistant pancreatic cancer.
How similar studies have performed: While CAR-T cell therapies have shown promise in other cancers, this specific approach targeting B7-H3 in pancreatic cancer is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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. Exclusion Criteria: 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.
Where this trial is running
Chapel Hill, North Carolina
- University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Ashwin Somasundaram, MD — UNC Lineberger Comprehensive Cancer Center
- Study coordinator: Catherine Cheng
- Email: UNCImmunotherapy@med.unc.edu
- Phone: +1 919-445-4208
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.