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Safety and Activity Study of PSCA-Targeted CAR-T Cells (BPX-601) in Subjects With Selected Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT02744287
Recruitment Status : Recruiting
First Posted : April 20, 2016
Last Update Posted : April 26, 2021
Sponsor:
Information provided by (Responsible Party):
Bellicum Pharmaceuticals

Brief Summary:
The purpose of this study is to evaluate the safety and activity of BPX-601 CAR-T cells in participants with previously treated advanced solid tumors (pancreatic and prostate) expressing high levels of prostate stem cell antigen (PSCA). Participants' T cells are modified to recognize and target the PSCA tumor marker on cancer cells.

Condition or disease Intervention/treatment Phase
Metastatic Castration-resistant Prostate Cancer Metastatic Prostate Cancer Metastatic Pancreatic Ductal Adenocarcinoma Metastatic Pancreatic Cancer Metastatic Pancreatic Adenocarcinoma Biological: BPX-601 Drug: Rimiducid Phase 1 Phase 2

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 or prostate). BPX-601 CAR-T cells are genetically engineered to express a chimeric antigen receptor (CAR) to target the PSCA antigen and a rimiducid-inducible signaling domain which functions as a molecular "go-switch" to enhance activation and proliferation.

Phase 1: Cell dose escalation to identify the maximum dose of BPX-601 administered with single or repeat doses of rimiducid (fixed dose of 0.4 mg/kg per infusion).

Phase 2: Indication-specific dose expansion to assess the safety, pharmacodynamics (including BPX-601 persistence), and clinical activity at the recommended dose identified in Phase 1 in various PSCA-expressing solid tumors.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 151 participants
Allocation: Non-Randomized
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 : October 2022
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1: Phase 1 Dose Escalation
Participants with advanced pancreatic or prostate cancer will receive an intravenous infusion of BPX-601 followed by one or more intravenous infusions of rimiducid. Dose escalation of BPX-601 will continue until the recommended cell dose level is reached.
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 proliferation and persistence
Other Name: AP1903

Experimental: Arm 2: Phase 2 Dose Expansion
Participants with advanced pancreatic or prostate cancer will receive an intravenous infusion of BPX-601 at the recommended cell dose level followed by one or more intravenous infusions of rimiducid.
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 proliferation and persistence
Other Name: AP1903




Primary Outcome Measures :
  1. Dose Limiting Toxicity [ Time Frame: 4 weeks after first rimiducid infusion (i.e., Day 35) ]
    Incidence of dose limiting toxicity

  2. Treatment emergent adverse events (AEs) and serious AEs (SAEs) [ Time Frame: 180 days after BPX-601 treatment up to 15 years ]
    Number of participants with adverse events (AEs) and serious AEs (SAEs) assessed for severity using NCI CTCAE v4.03

  3. Maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) [ Time Frame: through Phase 1 completion, up to 5 years ]
    Identify the optimal dose of BPX-601 with rimiducid for Phase 2


Secondary Outcome Measures :
  1. Pharmacodynamics (PD) of BPX-601 [ Time Frame: up to 1 year after treatment ]
    Change from baseline in pharmacodynamic blood biomarkers - markers of BPX-601 CAR-T cells

  2. Antitumor activity of BPX-601 [ Time Frame: From the time of BPX-601 cell infusion until confirmed disease progression or death due to any cause, the start of new anticancer therapy, or withdrawal, whichever comes first, as assessed for up to 5 years after the last subject has been enrolled ]
    Percentage of subjects with objective response determined by the investigator according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or the Prostate Cancer Working Group 3 (PCWG3) criteria



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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:

  • Metastatic pancreatic cancer with tumor progression within 6 months of the most recent anti-cancer treatment and documented positive tumor expression of PSCA, and prior treatment with first or second-line therapy; or,
  • Metastatic castration-resistant prostate cancer (mCRPC), with progressive disease per PCWG3 criteria during or following the direct prior line of therapy.
  • Measurable disease per RECIST v1.1 at baseline; subjects with mCRPC with bone only metastases must have measurable PSA.
  • Age ≥18 years.
  • Life expectancy > 12 weeks.
  • ECOG 0-1
  • Adequate organ function.

Exclusion Criteria:

  • Pancreatic cancer with islet cell neoplasms or symptomatic/untreated coagulopathy.
  • Prostate cancer with unstable bone lesions or symptomatic/untreated coagulopathy, or history of > Grade 2 hematuria within the previous 6 months.
  • Prior CAR T cell or other genetically-modified T cell therapy. Prior treatment with an immune-based therapy for the treatment of prostate cancer, including cancer vaccine therapies are allowable.
  • Symptomatic, untreated, or actively progressing central nervous system metastases.
  • Impaired cardiac function or clinically significant cardiac disease.
  • Pregnant or breastfeeding.
  • Participant requires chronic, systemic steroid therapy.
  • Severe intercurrent infection.
  • Known HIV positivity.

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
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Contact: BPX-601 Study Team 832-384-1100 012mail@bellicum.com

Locations
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United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Dae Won Kim, MD         
United States, Georgia
Emory Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Mehmet Akce, MD         
United States, New Jersey
John Theurer Cancer Center, Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Martin Gutierrez, MD         
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Gulam Manji, MD         
Principal Investigator: Gulam Manji, MD         
Principal Investigator: Mark Stein, MD         
United States, Tennessee
Tennessee Oncology, PLLC Withdrawn
Nashville, Tennessee, United States, 37203
United States, Texas
Baylor Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Contact: Carlos Becerra, MD         
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Ecaterina Dumbrava, MD         
Sponsors and Collaborators
Bellicum Pharmaceuticals
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Responsible Party: Bellicum Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02744287    
Other Study ID Numbers: BP-012
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: April 26, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
castration-resistant prostate cancer
rimiducid
pancreatic cancer
PSCA
CRPC
mCRPC
PDAC
Additional relevant MeSH terms:
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Prostatic Neoplasms
Adenocarcinoma
Pancreatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases