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

Primary Purpose

Metastatic Castration-resistant Prostate Cancer, Metastatic Prostate Cancer

Status
Suspended
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BPX-601
Rimiducid
Sponsored by
Bellicum Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Castration-resistant Prostate Cancer focused on measuring prostate stem cell antigen, BPX-601, AP1903, CAR-T, PSCA-CAR, castration-resistant prostate cancer, rimiducid, prostate cancer, PSCA, CRPC, mCRPC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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:

  • 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.

Sites / Locations

  • Moffitt Cancer Center
  • Emory Winship Cancer Institute
  • Rush University Medical Center
  • University of Chicago Medicine
  • Karmanos Cancer Institute
  • University of Nebraska
  • John Theurer Cancer Center, Hackensack University Medical Center
  • Roswell Park Cancer Institute
  • Columbia University Medical Center
  • Duke University
  • Thomas Jefferson University
  • Baylor Sammons Cancer Center
  • The University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm 1: Phase 1 Dose Escalation

Arm 2: Phase 2 Dose Expansion

Arm Description

Participants with advanced 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.

Participants with advanced 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.

Outcomes

Primary Outcome Measures

Dose Limiting Toxicity
Incidence of dose limiting toxicity
Treatment emergent adverse events (AEs) and serious AEs (SAEs)
Number of participants with adverse events (AEs) and serious AEs (SAEs) assessed for severity using NCI CTCAE v4.03
Maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D)
Identify the optimal dose of BPX-601 with rimiducid for Phase 2

Secondary Outcome Measures

Pharmacodynamics (PD) of BPX-601
Change from baseline in pharmacodynamic blood biomarkers - markers of BPX-601 CAR-T cells
Antitumor activity of BPX-601
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

Full Information

First Posted
April 11, 2016
Last Updated
April 18, 2023
Sponsor
Bellicum Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02744287
Brief Title
Safety and Activity Study of PSCA-Targeted CAR-T Cells (BPX-601) in Subjects With Selected Advanced Solid Tumors
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 Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Suspended
Why Stopped
Due to a Dose Limiting Toxicity.
Study Start Date
November 2016 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bellicum Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 (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.
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 (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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Castration-resistant Prostate Cancer, Metastatic Prostate Cancer
Keywords
prostate stem cell antigen, BPX-601, AP1903, CAR-T, PSCA-CAR, castration-resistant prostate cancer, rimiducid, prostate cancer, PSCA, CRPC, mCRPC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
151 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Phase 1 Dose Escalation
Arm Type
Experimental
Arm Description
Participants with advanced 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.
Arm Title
Arm 2: Phase 2 Dose Expansion
Arm Type
Experimental
Arm Description
Participants with advanced 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.
Intervention Type
Biological
Intervention Name(s)
BPX-601
Intervention Description
Autologous T cells genetically modified with retrovirus vector containing PSCA-specific CAR and an inducible MyD88/Cluster Designation (CD)40 (iMC) co-stimulatory domain
Intervention Type
Drug
Intervention Name(s)
Rimiducid
Other Intervention Name(s)
AP1903
Intervention Description
Dimerizer infusion to activate the iMC of the BPX-601 cells for improved proliferation and persistence
Primary Outcome Measure Information:
Title
Dose Limiting Toxicity
Description
Incidence of dose limiting toxicity
Time Frame
4 weeks after first rimiducid infusion (i.e., Day 35)
Title
Treatment emergent adverse events (AEs) and serious AEs (SAEs)
Description
Number of participants with adverse events (AEs) and serious AEs (SAEs) assessed for severity using NCI CTCAE v4.03
Time Frame
180 days after BPX-601 treatment up to 15 years
Title
Maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D)
Description
Identify the optimal dose of BPX-601 with rimiducid for Phase 2
Time Frame
through Phase 1 completion, up to 5 years
Secondary Outcome Measure Information:
Title
Pharmacodynamics (PD) of BPX-601
Description
Change from baseline in pharmacodynamic blood biomarkers - markers of BPX-601 CAR-T cells
Time Frame
up to 1 year after treatment
Title
Antitumor activity of BPX-601
Description
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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: 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.
Facility Information:
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Emory Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
University of Nebraska
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
John Theurer Cancer Center, Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Baylor Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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