Pancreas CancerPhase 1/2Panc 002NCT06479239
Study of EGFRBi Armed Fresh PBMC in Metastatic or Unresectable Pancreatic Cancer
A Phase 1/2 study testing EGFR FPBMC in people with Pancreas Cancer and Pancreatic Cancer, run by University of Virginia at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer, Pancreatic Cancer
- What is being tested?
- EGFR FPBMC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2024to Jun 2031
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Age ≥ 18 years
- Females of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment/registration
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- Females of childbearing potential and males must agree to use an effective method for contraception for the duration of the treatment with study drug plus 90 days (duration of sperm turnover). Males must also abstain from sperm donations during study treatment and for at least 90 days after the last dose of study drug.
- Adequate organ function within 14 days prior to registration, defined as the following:
- Absolute neutrophil count >= 500/mm3
- Absolute lymphocyte count >= 400/mm3
- Platelets >= 75,000/mm3
- Hemoglobin >= 8 g/dL
- Serum creatinine < 2.0mg/dL or calculated/measured creatinine clearance >= 50 ml/min
- Bilirubin <= 2 mg/dL
- Aspartate transferase (AST) and Alanine transaminase (ALT) <= 5.0 x upper limit of normal (ULN)
- Alpha gal < 0.35 IU/ml or "negative"
- Ability to provide informed consent and provision of written informed consent
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Adequate cardiac function as defined as:
- No uncontrolled angina or severe ventricular arrhythmias
- No clinically significant pericardial disease
- No history of myocardial infarction (MI) in the last year before registration
- No Class 3 or higher New York Heart Association Congestive Heart Failure
Who cannot join
- 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)
- Active infection; prior antibiotic/antifungal/antiviral therapies within 2 weeks prior to registration
- History of a myocardial infarction within 1 year prior to registration
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- Patients 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 are eligible for this trial
- Autoimmune disease that has required systemic treatment with chronic steroids or immunosuppressive therapy in the 2 years prior to registration (thyroxine, insulin, or corticosteroid replacement is allowed)
- History or evidence of any condition that might confound the results of the trial, interfere with the subject's participation, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
- Females must not be currently breast feeding.
- The treating investigator feels the patient is not able to be compliant.
- History of active Bacillus Tuberculosis (TB).
- Has received a live vaccine within 30 days of registration.
- Prisoners or patients who are incarcerated.
- Patients who are compulsorily detained for treatment of a psychiatric or physical illness.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
Ashley Donihee, 434-243-6377, zwz6jm@uvahealth.org
Sara Casana-Granell, 434-924-5254, QNA7WG@uvahealth.org
About this study
Official title: Phase I/II Study of Anti-CD3 x Anti-EGFR Bispecific Antibody (EGFRBi) Armed Fresh Peripheral Blood Mononuclear Cells (EGFR FPBMC) in Metastatic or Unresectable Pancreatic Cancer
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.
Read the detailed description
Once subjects are determined to be eligible, white blood cells (lymphocytes) are collected via leukapheresis procedure. The T cells in the mononuclear cells are coated with bispecific antibody to activate the T cells and the mononuclear cells are reinfused into the patients so the T cells can multiply and kill tumors.
About 72 hours after the leukapheresis procedure, EGFR FPBMC infusions will start. After about 8-9 weeks, participants will have another leukapheresis procedure and then receive doses every 2 weeks for 8 more doses. Before, throughout and following EGFR FPBMC, research blood will be collected to better understand immune response. Disease status will be checked regularly during and after study treatment.
- Conditions
- Pancreas Cancer, Pancreatic Cancer
- Being tested
- EGFR FPBMC
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGFR FPBMCDrug
Participants will receive 8 twice weekly infusions of EGFR FPBMC, then 8 additional infusions every 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| EGFR Fresh Peripheral Blood Mononuclear Cells | Experimental | 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. Receives: Drug: EGFR FPBMC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicities (DLTs) during the dose escalation phase (during the first 8 infusions only)
As defined in the protocol
Measured: Through the dose escalation phase (during the first 8 infusions only, about 4 weeks after starting study treatment))
Secondary outcomes (6)
Overall Response Rate
Number/Percentage of participants that have a partial or complete response to study treatment
Measured: Through the dose escalation phase (during the first 8 infusions only, about 4 weeks after starting study treatment))
Progression free survival
Time from start of treatment to time of progression or death from any cause, whichever occurs first.
Measured: Through 3 years after last infusion for each participant (a maximum of about 3 1/2 years)
Overall Survival
Time from start of treatment to time of death from any cause.
Measured: Through 3 years after last infusion for each participant (a maximum of about 3 1/2 years)
Specific cytotoxicity by PBMCs against pancreatic cancer cell lines
In blood samples
Measured: Before study treatment, about 8-9 weeks into study treatment, then 30-45 days, 6 months and 12 months after completion of study treatment
Development of antibodies to pancreatic cancer antigens
In blood samples
Measured: Before study treatment, about 8-9 weeks into study treatment, then 30-45 days, 6 months and 12 months after completion of study treatment
Survival of EGFR FPBMCs after multiple infusions
In blood samples
Measured: Prior to study treatment, prior to each of the first 5 infusions, (optionally) about 1-2 days after each of the first 8 infusions, and about 8-10 weeks after starting study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start6 Nov 2024
- Primary completionDec 2027 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tri Minh Le, MD, University of Virginia
- Investigators
- Tri Le, MD, DSc, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479239
- Sponsor's protocol ID
- HSR231503
- Acronym
- Panc 002
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2024
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Anti-CD3 x Anti-EGFR Bispecific Antibody (EGFRBi) Armed Fresh Peripheral Blood Mononuclear Cells (EGFR FPBMC) in Metastatic or Unresectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06479239
- Acronym / sponsor ID
- Panc 002 / HSR231503
- Conditions
- Pancreas Cancer, Pancreatic Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Once subjects are determined to be eligible, white blood cells (lymphocytes) are collected via leukapheresis procedure. The T cells in the mononuclear cells are coated with bispecific antibody to activate the T cells and the mononuclear cells are reinfused into the patients so the T cells can multiply and kill tumors.
About 72 hours after the leukapheresis procedure, EGFR FPBMC infusions will start. After about 8-9 weeks, participants will have another leukapheresis procedure and then receive doses every 2 weeks for 8 more doses. Before, throughout and following EGFR FPBMC, research blood will be collected to better understand immune response. Disease status will be checked regularly during and after study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EGFR Fresh Peripheral Blood Mononuclear Cells | Experimental | Drug: EGFR FPBMCParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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
- Age ≥ 18 years
Key exclusion criteria (15 listed)
- 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)
- Active infection; prior antibiotic/antifungal/antiviral therapies within 2 weeks prior to registration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EGFR FPBMCParticipants will receive 8 twice weekly infusions of EGFR FPBMC, then 8 additional infusions every 2 weeks. | Drug | EGFR Fresh Peripheral Blood Mononuclear Cells |
Primary outcome
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))
As defined in the protocol
6 secondary outcomes
Overall Response Rate
Time frame: Through the dose escalation phase (during the first 8 infusions only, about 4 weeks after starting study treatment))
Progression free survival
Time frame: Through 3 years after last infusion for each participant (a maximum of about 3 1/2 years)
Overall Survival
Time frame: Through 3 years after last infusion for each participant (a maximum of about 3 1/2 years)
Specific cytotoxicity by PBMCs against pancreatic cancer cell lines
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 treatment
Development of antibodies to pancreatic cancer antigens
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 treatment
Survival of EGFR FPBMCs after multiple infusions
Time frame: Prior to study treatment, prior to each of the first 5 infusions, (optionally) about 1-2 days after each of the first 8 infusions, and about 8-10 weeks after starting study treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tri Le, MD, DSc principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing EGFR FPBMC in people with Pancreas Cancer and Pancreatic Cancer, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashley Donihee (434-243-6377, zwz6jm@uvahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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))). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.