Study of EGFRBi Armed Fresh PBMC in Metastatic or Unresectable Pancreatic Cancer

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT06479239
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EGFR FPBMC — DRUG
    Participants will receive 8 twice weekly infusions of EGFR FPBMC, then 8 additional infusions every 2 weeks.

Study Details

The purpose of this study is to understand the safety and estimate the efficacy of combining anti-cluster of differentiation 3 (CD3) x anti-Epidermal Growth Factor Receptor (EGFR) bispecific antibody fresh peripheral blood mononuclear cells (EGFR FPBMC) for patients with metastatic or unresectable pancreas cancer. Participants receive 8 twice weekly doses and then 8 more doses every 2 weeks of EGFR FPBMC by intravenous infusion.

Key Dates

Start date
Nov 6, 2024
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2031

Study Design

Enrollment
23 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: EGFR Fresh Peripheral Blood Mononuclear Cells
    Participants will undergo apheresis to collect cells to make EGFR fresh peripheral blood mononuclear cells (FPBMC). These cells will be activated in the lab to fight against pancreas cancer. About 3-4 days after apheresis, participants will start receiving infusions of EGFR FPBMC. Throughout treatment, participants will have blood taken for labs, to check disease status and also to look at immune response. Study treatment will stop if the participant has disease progression. Participants that have disease progression after the first 8 infusions may receive chemotherapy and then continue study treatment with the other 8 infusions.

Primary Outcome Measure

Dose limiting toxicities (DLTs) during the dose escalation phase (during the first 8 infusions only) [ Time Frame: Through the dose escalation phase (during the first 8 infusions only, about 4 weeks after starting study treatment)) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22903
Ashley Donihee
[email protected]
434-243-6377
Sara Casana-Granell
[email protected]
434-924-5254
Tri Le, MD, DSc (PRINCIPAL_INVESTIGATOR)

Find similar trials in Charlottesville, VA

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
University of Virginia· Charlottesville, VA

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