EGFR BATs for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

Overseen byTri Le, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: University of Virginia

No Placebo Group

Trial Summary

What is the purpose of this trial?This protocol will confirm toxicities and estimate the clinical efficacy of combining anti-CD3 x anti-EGFR bispecific antibody (EGFRBi) armed activated T cells (EGFR BATs) given to patients with locally advanced or metastatic pancreatic cancer who have received at least one dose of first line chemotherapy and may have responding, stable or progressive disease. Phase Ib will confirm a safe dose of 8 infusions, given twice weekly, of EGFR-BATs in 3 to 6 subjects. The phase II portion of the trial will test the clinical efficacy of this dose in 22 patients (including those in Phase Ib).

Eligibility Criteria

Adults with pancreatic adenocarcinoma who've had at least one chemo treatment can join this trial. They should have a life expectancy of over 3 months, be in good physical condition, and not planning to get pregnant or father a child. People with serious health issues, recent surgeries, active infections, certain drug treatments within the last few weeks or other cancers in the past 5 years are excluded.

Inclusion Criteria

I have pancreatic cancer that has spread and received chemotherapy.

You are expected to live for at least 3 more months.

I am 18 years or older and can consent to my own medical treatment.

+5 more

Exclusion Criteria

Treatment with any investigational agent within 14 days prior to first study intervention (apheresis) for protocol therapy

Capability of being compliant, as determined by the PI and investigator team

History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate

+15 more

Participant Groups

The trial is testing EGFR BATs (a type of immune cell therapy) after standard chemotherapy for pancreatic cancer. Phase Ib will find a safe dose through 8 infusions twice weekly for up to 6 subjects. Phase II will assess how well this works in about 22 patients.

1Treatment groups

Experimental Treatment

Group I: EGFR BATs after standard of care chemoExperimental Treatment1 Intervention

Subjects will undergo apheresis to collect peripheral blood mononuclear cells. Cells will be cultured for up to 2 weeks before activated T-cells will be harvested, armed with EGFR Biarmed activated T-cells, washed to remove unbound EGFRBi, and cryopreserved. Subjects will then receive one dose of standard of care chemotherapy prior to receiving EGFR BATs.