Clinical trial · Interventional
Pilot Study of Autologous T-cells in Patients With Metastatic Pancreatic Cancer
Pilot Study of Autologous T-cells Redirected to Mesothelin and CD19 With a Chimeric Antigen Receptor in Patients With Metastatic Pancreatic Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of efficacy and funding to continue investigation
Summary
Brief summary (as posted)
This is a study in which pancreatic cancer patients receive a combination therapy with CART-meso cells and CART19 cells administered at 3 days after one dose of cyclophosphamide. CART-meso cells are patients' own T cells that were modified in the laboratory to express a receptor specific to the mesothelin protein. CART19 cells are patients' own T cells that were modified in the laboratory to express a receptor specific to a protein called CD19. The CD19 protein is expressed on white blood B cells. CART19 cells are expected to attack the B cells and impede the antibody response against CART-meso cells. The investigators hypothesize that this combination therapy may prolong the duration of CART-meso cells in the body. Additionally, one dose of cyclophosphamide may enhance engraftment and persistence 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CART-meso-19 T cells | Biological | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CART-meso-19 T cells
- description
- A single dose of CART-meso-19 T cells (combination therapy with CART-meso and CART19 cells) will be administered intravenously as two separate infusions. The dose is 1-3x107/m2 (Cohort 1) or 1-3x108/m2 (Cohort 2) CART positive cells. The infusion will be scheduled to occur 3 (±1) days after a single dose of 1.5 grams/m2 of cyclophosphamide, which will be administered according to standard procedures in the outpatient setting.
- interventionNames
- Biological: CART-meso-19 T cells
- Drug: Cyclophosphamide
Primary outcomes (1)
- measure
- Safety of IV administration of CART-meso-19 with cyclophosphamide as lymphodepleting chemotherapy in patients with pancreatic cancer using the NCI CTCAE v4.03 criteria
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent * Unresectable or metastatic pancreatic cancer * Persistent cancer after at least one prior standard of care chemotherapy for advanced stage disease * 18 years of age and older * ECOG performance status of 0 or 1 * Life expectancy greater than 3 months * Satisfactory organ and bone marrow function * Meets blood coagulation parameters * Male and Female subjects of reproductive potential agree to use approved contraceptive methods Exclusion Criteria: * Participation in a therapeutic investigational study within 4 weeks prior to the screening visit * Anticipated need for systemic chemotherapy within 2 weeks before apheresis and infusion * Active invasive cancer other than pancreatic cancer * HIV, HCV, or HBV infections * Active autoimmune disease requiring immunosuppressive therapy within 4 weeks prior to screening visit, with exception of thyroid replacement * Ongoing or active infection * Planned concurrent treatment with systemic high dose corticosteroids * Patients requiring supplemental oxygen therapy * Prior therapy with gene modified cells * Previous experimental therapy with SS1 moiety, murine or chimeric antibodies * History of allergy to murine proteins * History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40) * Clinically significant pericardial effusion, CHF, or cardiovascular condition that would preclude assessment of mesothelin induced pericarditis or that may worsen as a result of toxicities expected for this study * Pregnant or breastfeeding women
References
Publications (0)
Data not yet available