RecruitingPhase 1

Autologous CAR-T Cells Targeting B7-H3 in PDAC

United States27 participantsStarted 2024-07-18

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. Age ≥ 18 years at the time of consent.
✓. Eastern Cooperative Oncology Group of 0-1 Performance Status)
✓. Histological or cytological evidence/confirmation of pancreatic ductal adenocarcinoma.
✓. 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.
✓. 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

✕. 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.
✕. Subject is not willing and able to comply with study procedures based on the judgment of the investigator.

What they're measuring

Number of participants with adverse event

Timeframe: Up to 4 weeks

Cytokine Release Syndrome

Timeframe: Up to 4 weeks

Neurotoxicity

Timeframe: Up to 4 weeks

Trial details

NCT IDNCT06158139

SponsorUNC Lineberger Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-04

Contact for this trial

Catherine Cheng

+1 919-445-4208 UNCImmunotherapy@med.unc.edu

View on ClinicalTrials.gov More Pancreas Cancer trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. Age ≥ 18 years at the time of consent.
✓. Eastern Cooperative Oncology Group of 0-1 Performance Status)
✓. Histological or cytological evidence/confirmation of pancreatic ductal adenocarcinoma.
✓. 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.
✓. 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

✕. 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.
✕. Subject is not willing and able to comply with study procedures based on the judgment of the investigator.