Autologous CARTmeso/19 Against Pancreatic Cancer

Wenzhou Medical University

Status and phase: Unknown; Early Phase 1

Conditions: Pancreatic Cancer

Treatments: Biological: CARTmeso CART19

Study type: Interventional

Funder types: Other

Identifiers

NCT03497819

YXA-meso19

Details and patient eligibility

About

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.

Full description

This is a single arm, open-label, pilot study to determine the safety and feasibility of combination CARTmeso cells and CART19 cells in patients with pancreatic cancer following lymphodepletion with cyclophosphamide. Both cells contain CAR proteins consisting of a murine-derived single chain antibody fragment (scFv), cluster of differentiation antigen 137 (41BB) co-stimulatory domain and cluster of differentiation antigen 3 zeta chain (CD3ζ) signaling domain transduced by lentivirus

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

CARTmeso/19 treatment arm

Experimental group

Description:

Patients with pancreatic cancer receiving CARTmeso and CART19 autologous cells via artery infusion or i.v. with cyclophosphamide precondition

Treatment:

Biological: CARTmeso CART19