Using CAR-T cells to target B7-H3 in pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Treatment using CAR-T cells targeting B7-H3 for triple-negative breast cancer

  This study is testing a new CAR-T cell treatment aimed at a specific target for people with hard-to-treat triple-negative breast cancer to see if it is safe and how much can be given.

  Recruiting Phase 1 UNC Lineberger Comprehensive Cancer Center · Chapel Hill, North Carolina · NCT06347068

• In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed or Refractory B-Cell Lymphoma

  This early-phase trial tests a one-time in vivo CAR T-cell therapy (SL1617) for people with relapsed or refractory B-cell lymphoma to see if it is safe and tolerable.

  Recruiting Phase 1 Chinese PLA General Hospital · Beijing · NCT07775508

• CEA-targeted CAR-T for advanced CEA-positive solid tumors

  This trial will try CEA-targeted CAR-T cell infusions in adults with advanced CEA-positive cancers (such as colorectal, gastric, esophageal, lung, or pancreatic cancer) to see if the treatment is safe and helps control the disease.

  Recruiting Phase 1 Chongqing Precision Biotech Co., Ltd · Hefei, Anhui · NCT07179692

• CD5 CAR T-cell therapy for relapsed or refractory T-cell lymphoma

  This trial tries CD5 CAR T-cell therapy, using either the patient's own cells or donor cells, and may bridge to stem-cell transplant for people 14–70 with relapsed or refractory T-cell lymphoma.

  Recruiting at 3 sites Phase 1/2 Beijing GoBroad Hospital · Beijing and 2 other locations · NCT07022964

• Glofitamab plus obinutuzumab for mantle cell lymphoma after CAR‑T

  This trial tests whether the antibody drug glofitamab given with obinutuzumab can shrink or control mantle cell lymphoma that returned or didn't respond after CD19 CAR‑T therapy in adults.

  Recruiting at 11 sites Phase 2 National Cancer Institute (NCI) · Duarte, California and 10 other locations · NCT07003295

• CD7 CAR T-Cell Therapy for T-Cell Lymphomas

  This study is testing a new CAR T-cell therapy for people with T-cell lymphomas that haven't responded to regular treatments to see if it is safe and effective.

  Recruiting at 4 sites Phase 1/2 Beijing GoBroad Hospital · Beijing, Beijing Municipality and 3 other locations · NCT06925464

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.