NCT06158139 Autologous CAR-T Cells Targeting B7-H3 in PDAC
| NCT ID | NCT06158139 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | UNC Lineberger Comprehensive Cancer Center |
| Condition | Pancreas Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 27 participants |
| Start Date | 2024-07-18 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 27 participants in total. It began in 2024-07-18 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Ashwin Somasundaram, MD
PRINCIPAL INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT06158139 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreas Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06158139 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06158139 currently recruiting?
Yes, NCT06158139 is actively recruiting participants. Contact the research team at UNCImmunotherapy@med.unc.edu for enrollment information.
Where is the NCT06158139 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT06158139 clinical trial?
NCT06158139 is sponsored by UNC Lineberger Comprehensive Cancer Center. The principal investigator is Ashwin Somasundaram, MD at UNC Lineberger Comprehensive Cancer Center. The trial plans to enroll 27 participants.
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