Metastatic Castration-resistant Prostate Cancer, Metastatic Prostate Cancer
Conditions
Keywords
prostate stem cell antigen, BPX-601, AP1903, CAR-T, PSCA-CAR, castration-resistant prostate cancer, rimiducid, prostate cancer, PSCA, CRPC, mCRPC
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
Former Sponsor Bellicum Pharmaceuticals Study ended prior to the start of Phase 2
Interventions
BIOLOGICALBPX-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
DRUGRimiducid
Dimerizer infusion to activate the iMC of the BPX-601 cells for improved proliferation and persistence
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Limiting Toxicity | 4 weeks after first rimiducid infusion (i.e., Day 35) | Incidence of dose limiting toxicity |
| Treatment emergent adverse events (AEs) and serious AEs (SAEs) | 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) | through Phase 1 completion, up to 5 years | Identify the optimal dose of BPX-601 with rimiducid for Phase 2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacodynamics (PD) of BPX-601 | 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 | 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 |
Countries
United States
Contacts
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed