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Prostate Stem Cell Antigen (PSCA)-Specific CAR T Cells In Subjects With Non-Resectable Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT02744287
Recruitment Status : Recruiting
First Posted : April 20, 2016
Last Update Posted : December 7, 2017
Sponsor:
Information provided by (Responsible Party):
Bellicum Pharmaceuticals

Brief Summary:
In this protocol, patients with non-resectable pancreatic cancer will have autologous T cells collected via apheresis and genetically modified using a retrovirus to express the anti-PSCA Chimeric Antigen Receptor (CAR). The T cells will be reinfused according to a dose-finding schedule after the subject has been identified as having adequate lymphopenia to provide for homeostatic expansion of the adoptively transferred, engineered T cell therapeutic product.

Condition or disease Intervention/treatment Phase
Non-Resectable Pancreatic Cancer Biological: BPX-601 Drug: Rimiducid Phase 1

Detailed Description:
This is a Phase I, single center, open-label, non-randomized, feasibility, safety and dose-finding study. The purpose of the clinical trial is to determine the safety of the administration of the anti-PSCA CAR T cells (BPX-601) in subjects with non-resectable pancreatic adenocarcinoma, followed by the evaluation of the safety of the rimiducid infusion after BPX-601 administration, and the persistence of the CAR-T cells over time after a single rimiducid infusion.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility and Safety Study of PSCA-Specific Chimeric Antigen Receptor Engineered T Cells (BPX-601) in Subjects With Non-Resectable Pancreatic Cancer
Study Start Date : November 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BPX-601 and Rimiducid (AP1903)
PSCA specific CAR modified autologous T cells and dimerizer agent which stimulates CAR
Biological: BPX-601
Autologous T cells genetically modified with retrovirus vector containing PSCA-specific CAR and an inducible MyD88/ Cluster Designation (CD)40 (iMC) co-stimulatory domain

Drug: Rimiducid
Dimerizer infusion to activate the iMC of the BPX-601 cells for improved persistence
Other Name: AP1903




Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) and/or recommended extension dose of BPX-601 measured by dose limiting toxicities (DLT)s [ Time Frame: 14 days post-treatment infusion ]
    recommended extension dose of BPX-601



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the pancreas with non-resectable disease. Subjects with mixed histology may be included if the predominant component is adenocarcinoma.
  • Tumor with positive PSCA expression.
  • Failed standard therapy (chemotherapy or surgery) or investigational therapy for non- resectable disease, or have documented refusal of standard treatments.
  • Tumor must be evaluable by CT scan (or MRI, if subject is allergic to CT contrast media).
  • Age ≥ 18 years.
  • If a female subject is of child-bearing potential, she must have a negative serum pregnancy test documented prior to administration of BPX-601.
  • If sexually active, the subject must agree to use contraception considered adequate and appropriate by the Investigator for 3 months after administration of BPX-601.
  • Life expectancy >12 weeks.
  • Signed informed consent.
  • Performance status: Karnofsky score > 60%.
  • Subjects must have adequate venous access for apheresis or agree to use of central line for apheresis collection.
  • Subject has adequate organ function as measured by:

    1. Cardiac: left ventricular ejection fraction at rest must be ≥ lower limit of institutional normal.
    2. Hematologic: i) White Blood Cell (WBC) ≥ 2,000/μl, ii) Absolute Neutrophil Count (ANC) ≥ 1,000/μl, iii) Platelets ≥ 50 x 10^3/μl, iv) Hemoglobin ≥ 9 g/dL.
    3. Hepatic: direct bilirubin ≤ 1.5 x upper limit of normal, or aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal.
    4. Renal: creatinine ≤ 1.5 x upper limit of normal.
    5. Pulmonary: forced expiratory volume (FEV) 1, forced vital capacity (FVC), diffusing capacity of lung for carbon monoxide (DLCO) ≥ 50% predicted (corrected for hemoglobin).

Exclusion Criteria:

  • Subjects with islet cell neoplasms.
  • Participation in any investigational drug study < 28 days prior to BPX-601 infusion.
  • Chemotherapy or immunotherapy < 2 weeks prior to BPX-601, other than salvage/lymphodepletion chemotherapy.
  • Active autoimmune disease requiring immunosuppressive therapy < 4 weeks prior to screening.
  • Treatment with systemic high dose prednisone of ≥ 0.5mg/kg/day or its equivalents and within 7 half-lives of the prescribed corticosteroid prior to the date of leukapheresis for BPX-601 infusion.
  • Uncontrolled bacterial, viral or fungal infection, or any medical condition determined by the Investigator to be a risk for enrolling on the protocol.
  • Known HIV, hepatitis B virus (HBV),hepatitis C virus (HCV) positivity or subject not meeting the selection criteria as defined for the Foundation for the Accreditation of Cell Therapy (FACT) and American Association of Blood Banks (AABB).
  • Positive serum or urine β human chorionic gonadotropin (HCG) test or breast-feeding.
  • Fertile men or women unwilling to use effective forms of birth control or abstinence for 3 months after BPX-601 administration.
  • Bovine product allergy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02744287


Contacts
Contact: Carlos Becerra, MD 214-818-8472

Locations
United States, Texas
Baylor Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Contact: Carlos Becerra, MD    214-818-8472      
Sponsors and Collaborators
Bellicum Pharmaceuticals
Investigators
Principal Investigator: Carlos Becerra, MD Baylor Health Care System

Responsible Party: Bellicum Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02744287     History of Changes
Other Study ID Numbers: BP-012
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Bellicum Pharmaceuticals:
Non Resectable Pancreatic Cancer
BPX-601
AP1903
CAR T
PSCA-CAR

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases