Study of EGFRBi Armed Fresh PBMC in Metastatic or Unresectable Pancreatic Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Virginia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed locally advanced pancreatic cancer (LAPC)/unresectable pancreatic cancer (UPC) or metastatic pancreatic cancer (MPC) not eligible for curative intent therapy
Received at least 1 line of chemotherapy and have stable disease (SD) or better for 3 months prior to enrollment. Therapy should consist of either a gemcitabine, 5FU-based (including capecitabine) or albumin-bound paclitaxel-based regimen. Patients with actionable mutations should have received targeted therapy prior to enrollment on trial. Patients who qualify for immunotherapy due to mismatch repair protein/microsatellite stable and tumor mutational burden status should also have received immunotherapy prior to enrollment on trial.
Measurable disease by immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
Disqualifiers
Known hypersensitivity to cetuximab
Treatment with investigational agent within 3 weeks prior to registration
Serious non-healing wound, ulcer, bone fracture, major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration
Known active liver disease, human immunodeficiency virus (HIV)+ or evidence of active Hepatitis C or B virus; bleeding or condition associated with high-risk bleeding (anticoagulation is allowed)
Trial design
Design model
Single group
Treatments tested in this trial
EGFR FPBMC
DrugParticipants will receive 8 twice weekly infusions of EGFR FPBMC, then 8 additional infusions every 2 weeks.
Treatment groups
23 Participants
are divided into 1 treatment groupGroup A: EGFR Fresh Peripheral Blood Mononuclear CellsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose limiting toxicities (DLTs) during the dose escalation phase (during the first 8 infusions only)
As defined in the protocol
Time frame
Through the dose escalation phase (during the first 8 infusions only, about 4 weeks after starting study treatment))Secondary outcomes
1
Overall Response Rate
Number/Percentage of participants that have a partial or complete response to study treatment
Time frame
Through the dose escalation phase (during the first 8 infusions only, about 4 weeks after starting study treatment))2
Progression free survival
Time from start of treatment to time of progression or death from any cause, whichever occurs first.
Time frame
Through 3 years after last infusion for each participant (a maximum of about 3 1/2 years)3
Overall Survival
Time from start of treatment to time of death from any cause.
Time frame
Through 3 years after last infusion for each participant (a maximum of about 3 1/2 years)4
Specific cytotoxicity by PBMCs against pancreatic cancer cell lines
In blood samples
Time frame
Before study treatment, about 8-9 weeks into study treatment, then 30-45 days, 6 months and 12 months after completion of study treatmentSponsors and contacts
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Source ClinicalTrials.gov