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Trial record 1 of 1 for:    BPX-601
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Safety and Activity of Autologous T Cells Engineered to Target PSCA on Tumor Cells in Selected Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT02744287
Recruitment Status : Recruiting
First Posted : April 20, 2016
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
Bellicum Pharmaceuticals

Brief Summary:
Participants with previously treated advanced solid tumors (pancreatic, stomach or prostate cancers) expressing high levels of prostate stem cell antigen (PSCA) will receive BPX-601 T cells. The participants' own T cells are modified to recognize PSCA tumor marker on cancer cells and target them.

Condition or disease Intervention/treatment Phase
Pancreatic Adenocarcinoma Gastric Adenocarcinoma Prostate Adenocarcinoma Biological: BPX-601 Drug: Rimiducid Phase 1

Detailed Description:

The goal of this study is to characterize the feasibility, safety, and clinical activity of PSCA-specific CAR-T cells, BPX-601, administered with rimiducid to subjects with previously treated, PSCA-positive advanced solid tumors (pancreatic, gastric/GEJ, prostate cancers). The CAR T cells have an inducible signaling domain (iMC) which functions as a molecular switch to enhance and control the activation and proliferation of the CAR T cells in the presence of the small molecule rimiducid.

The study will be comprised of multiple parts:

  • Part 1 (Phase 1): Cell dose escalation to identify the maximum dose of BPX-601 T cells (escalating doses from 1.25 x 10E6 cells/kg up to 5.0 x 10E6 cells/kg to be explored) administered with rimiducid (fixed single-dose at 0.4 mg/kg)
  • Parts 2 and 3 (Phase 2): Indication-specific dose expansion to assess the safety, pharmacodynamics (including BPX-601 T cell persistence), and clinical activity at the recommended dose identified in Part 1 in various PSCA-expressing solid tumors

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Feasibility, Safety, and Activity Study of PSCA-Specific Chimeric Antigen Receptor Engineered T Cells (BPX-601) in Subjects With Previously Treated Advanced Solid Tumors
Study Start Date : November 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

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

  2. Frequency and severity of treatment emergent adverse events (AEs) and serious AEs (SAEs) assessed for severity using NCI CTCAE v4.03 [ Time Frame: baseline to 1 year ]
    Incidences of AEs and SAEs- change in safety parameters from baseline



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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, Florida
Moffitt Cancer Center Not yet recruiting
Tampa, Florida, United States, 33612
Contact: Donna Evans    813-745-7238    Donna.Evans2@moffitt.org   
Principal Investigator: Dae Won Kim, MD         
United States, New York
Columbia University Medical Center Not yet recruiting
New York, New York, United States, 10032
Contact: Ana Serra    212-342-0248    as5713@cumc.columbia.edu   
Principal Investigator: Gulam Manji, MD         
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: September 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bellicum Pharmaceuticals:
prostate stem cell antigen
BPX-601
AP1903
CAR T
PSCA-CAR
Hormone-refractory prostate cancer

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms