Clinical trial · Interventional
Autologous CARTmeso/19 Against Pancreatic Cancer
Pilot Study of Autologous Chimeric Antigen Receptor Cells Against Mesothelin and CD19 in Patients With Pancreatic Cancer
- 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)
Pancreatic cancer patients receive chimeric antigen receptor (CAR) T cells against mesothelin (CARTmeso) or CD19 (CART19) cells administered at 3 days via pancreatic artery infusion or i.v. after preconditioning of cyclophosphamide. Both CART cells are autologous. CARTmeso cells target pancreatic cells which highly express mesothelin, while CART19 cells target tumor-associated B cells expressing cluster of differentiation antigen 19 (CD19) which are mostly immunosuppressive. The investigators hypothesize that this combination therapy may enhance the efficacy of CARTmeso cells in the body. Additionally, a medium dose of cyclophosphamide is used to enhance the engraftment of CART cells.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CARTmeso CART19 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CARTmeso/19 treatment arm
- description
- Patients with pancreatic cancer receiving CARTmeso and CART19 autologous cells via artery infusion or i.v. with cyclophosphamide precondition
- interventionNames
- Biological: CARTmeso CART19
Primary outcomes (1)
- measure
- The Percentage of Adverse Events (AEs) ≥ grade 3 assessed through MedDra and CTCAE v4.03 [Time frame: from infusion to 3 month afterward]
- timeFrame
- From first infusion to 3 months afterward
- description
- Primary outcome is the percentage of adverse events (AEs) ≥ grade 3. AEs are assessed through MedDra and CTCAE v4.03. Any patients who receive any dose of CART cells will be evaluated
Secondary outcomes (1)
- measure
- Overall Response Rate defined as any improvement measured by imaging following RECIST 1.1 [Time Frame: Day 14 and 1 month after infusion]
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent * serum soluble mesothelin-related protein (SMRP) \> 0.4 nanomolar/L * Persistent cancer after at least one prior standard of care chemotherapy for advanced stage disease * 18 years of age and ≤65 * Life expectancy greater than 3 months * Satisfactory organ and bone marrow function Exclusion Criteria: * Participation in a therapeutic investigational study within 4 weeks prior to the screening visit * Active invasive cancer other than pancreatic cancer * HIV, hepatitis B/C virus, or infections * Active autoimmune disease requiring immunosuppressive therapy within 4 weeks * Planned concurrent treatment with systemic high dose corticosteroids * Patients requiring supplemental oxygen therapy * Pregnant or breastfeeding women
References
Publications (0)
Data not yet available