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 :
Suspended
(Due to a Dose Limiting Toxicity.)
First Posted : April 20, 2016
Last Update Posted : April 20, 2023
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Condition or disease | Intervention/treatment | Phase |
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Metastatic Castration-resistant Prostate Cancer Metastatic Prostate Cancer | Biological: BPX-601 Drug: Rimiducid | Phase 1 Phase 2 |
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.
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 |
Actual Study Start Date : | November 2016 |
Estimated Primary Completion Date : | October 2025 |
Estimated Study Completion Date : | February 2026 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm 1: Phase 1 Dose Escalation
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.
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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 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.
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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 |
- Dose Limiting Toxicity [ Time Frame: 4 weeks after first rimiducid infusion (i.e., Day 35) ]Incidence of dose limiting toxicity
- 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
- 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
- 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
- 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 |
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.

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
United States, Florida | |
Moffitt Cancer Center | |
Tampa, Florida, United States, 33612 | |
United States, Georgia | |
Emory Winship Cancer Institute | |
Atlanta, Georgia, United States, 30322 | |
United States, Illinois | |
Rush University Medical Center | |
Chicago, Illinois, United States, 60612 | |
University of Chicago Medicine | |
Chicago, Illinois, United States, 60637 | |
United States, Michigan | |
Karmanos Cancer Institute | |
Detroit, Michigan, United States, 48201 | |
United States, Nebraska | |
University of Nebraska | |
Omaha, Nebraska, United States, 68198 | |
United States, New Jersey | |
John Theurer Cancer Center, Hackensack University Medical Center | |
Hackensack, New Jersey, United States, 07601 | |
United States, New York | |
Roswell Park Cancer Institute | |
Buffalo, New York, United States, 14263 | |
Columbia University Medical Center | |
New York, New York, United States, 10032 | |
United States, North Carolina | |
Duke University | |
Durham, North Carolina, United States, 27705 | |
United States, Pennsylvania | |
Thomas Jefferson University | |
Philadelphia, Pennsylvania, United States, 19107 | |
United States, Texas | |
Baylor Sammons Cancer Center | |
Dallas, Texas, United States, 75246 | |
The University of Texas MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
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 20, 2023 |
Last Verified: | April 2023 |
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 |
prostate stem cell antigen BPX-601 AP1903 CAR-T PSCA-CAR castration-resistant prostate cancer |
rimiducid prostate cancer PSCA CRPC mCRPC |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms |
Genital Diseases, Male Genital Diseases Urogenital Diseases Prostatic Diseases Male Urogenital Diseases |