Clinical trial · Interventional
A Study of Armed, Activated T-Cells in Patients With Advanced Pancreatic Cancer
Phase Ib Treatment of Advanced Pancreatic Cancer With Anti-CD3 x Anti-EGFR-Bispecific Antibody Armed Activated T-Cells (BATs)
NCT04137536CI-TRIAL-00111708active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to find the safest dose and identify any bad side effects of EGFR-BATs (bispecific antibody-armed activated T cells) for people with advanced pancreatic cancer who have already received first-line standard chemotherapy.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anti-EGFR-bispecific antibody armed activated T-cells | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pancreatic Adenocarcinoma
- description
- Participants have metastatic pancreatic cancer who have received at least first line chemotherapy and have disease progression during or within 6 months of treatment.
- interventionNames
- Drug: anti-EGFR-bispecific antibody armed activated T-cells
Primary outcomes (1)
- measure
- Evaluate toxicity
- timeFrame
- 1 year
- description
- The NCI CTEP CTCAE v4.0 will be used.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological or cytological proof of pancreatic adenocarcinoma. Must have metastatic pancreatic cancer who have received at least first line chemotherapy. Disease stability or progression during or within 6 months after treatment with 5-Fluorouracil (5-FU)- or gemcitabine-based chemotherapy. KPS\>/= 70% or SWOG performance Status 0 or 1 * Evaluable disease by iRECIST criteria * Absolute Neutrophil Count (ANC) \>/= 1,000/mm\^3 * Lymphocyte count \>/= 400/mm\^3 * Platelet Count \>/= 75,000/mm\^3 * Hemoglobin \>/= 8 g/dL * Serum Creatinine \< 2.0 mg/dl, Creatinine Clearance \>/=50 ml/mm (can be calculated or measured) * Total Bilirubin \</= 2 mg/dl (biliary stent is allowed) * SGPT and SGOT \<5.0 times normal * LVEF \>/= 55% at rest (\<UGA or Echo) * Age \>/= 18 years at the time of consent (Written informed consent and HIPAA authorization for release of personal health information) * Females of childbearing potential, and males, must be willing to use an effective method of contraception * Females of childbearing potential must have a negative pregnancy test within 7 days of being registered for protocol therapy Exclusion Criteria: * Any chemotherapy related toxicities from prior treatment, \> grade 2 per CTCAE v4.0 * Known hypersensitivity to cetuximab or other EGFR antibody * Treatment with any investigational agent within 14 days prior to being registered for protocol therapy * Symptomatic brain metastasis * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Steroid premedication for imaging scans is allowed. Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. * Serious non-healing wound, ulcer, bone fracture, major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to being registered for protocol therapy * Active liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis * Known HIV infection * Active bleeding or a pathological condition that is associated with a high risk of bleeding (therapeutic anticoagulation is allowed) * Has an active infection requiring systemic therapy * A serious uncontrolled medical disorder that in the opinion of the Investigator may be jeopardized by the treatment with protocol therapy. * Females must not be breastfeeding * Patient may be excluded if, in the opinion of the PI and investigator team, the patient is not capable of being compliant
References
Publications (1)
- DERIVEDPark JA, Santich BH, Xu H, Lum LG, Cheung NV. Potent ex vivo armed T cells using recombinant bispecific antibodies for adoptive immunotherapy with reduced cytokine release. J Immunother Cancer. 2021 May;9(5):e002222. doi: 10.1136/jitc-2020-002222. PMID 33986124