Pilot Study of Autologous T-cells in Patients With Metastatic Pancreatic Cancer
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Pancreatic Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/1/2018 |
| Start Date: | May 2015 |
| End Date: | November 2017 |
Pilot Study of Autologous T-cells Redirected to Mesothelin and CD19 With a Chimeric Antigen Receptor in Patients With Metastatic Pancreatic Cancer
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.
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.
Immunotherapy is a novel and promising approach for the treatment of solid tumors;
immunotherapy with chimeric antigen receptor (CAR) T cells (CART cells) in particular has the
potential advantage of targeted therapies that can invoke a rapid tumor response, and the
advantage of long-lived responses that are the hallmark of engagement of the adaptive immune
system such as memory T cells.
This is a single arm, open-label, phase I study to determine the safety and feasibility of
combination CART-meso cells (autologous T cells lentivirally transduced to express
anti-mesothelin scFv fused to TCRζ and 4-1BB costimulatory domains) and CART19 cells
(autologous T cells lentivirally transduced to express a humanized anti-CD19 scFv fused to
TCRζ and 4-1BB costimulatory domains) in patients with pancreatic cancer following
lymphodepletion with cyclophosphamide.
immunotherapy with chimeric antigen receptor (CAR) T cells (CART cells) in particular has the
potential advantage of targeted therapies that can invoke a rapid tumor response, and the
advantage of long-lived responses that are the hallmark of engagement of the adaptive immune
system such as memory T cells.
This is a single arm, open-label, phase I study to determine the safety and feasibility of
combination CART-meso cells (autologous T cells lentivirally transduced to express
anti-mesothelin scFv fused to TCRζ and 4-1BB costimulatory domains) and CART19 cells
(autologous T cells lentivirally transduced to express a humanized anti-CD19 scFv fused to
TCRζ and 4-1BB costimulatory domains) in patients with pancreatic cancer following
lymphodepletion with cyclophosphamide.
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
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