Not provided
Not provided
Not provided
Not provided
Not provided
Due to a Dose Limiting Toxicity.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Former Sponsor Bellicum Pharmaceuticals
Study ended prior to the start of Phase 2
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Phase 1 Dose Escalation | Experimental | 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 2: Phase 2 Dose Expansion | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BPX-601 | Biological | Autologous T cells genetically modified with retrovirus vector containing PSCA-specific CAR and an inducible MyD88/Cluster Designation (CD)40 (iMC) co-stimulatory domain |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicity | Incidence of dose limiting toxicity | 4 weeks after first rimiducid infusion (i.e., Day 35) |
| 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 | 180 days after BPX-601 treatment up to 15 years |
| Maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) | Identify the optimal dose of BPX-601 with rimiducid for Phase 2 | through Phase 1 completion, up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics (PD) of BPX-601 | Change from baseline in pharmacodynamic blood biomarkers - markers of BPX-601 CAR-T cells | up to 1 year after treatment |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States | ||
| Emory Winship Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39737899 | Derived | Stein MN, Dumbrava EE, Teply BA, Gergis US, Guiterrez ME, Reshef R, Subudhi SK, Jacquemont CF, Senesac JH, Bayle JH, Scripture CD, Chatwal MS, Bilen MA, Stadler WM, Becerra CR. PSCA-targeted BPX-601 CAR T cells with pharmacological activation by rimiducid in metastatic pancreatic and prostate cancer: a phase 1 dose escalation trial. Nat Commun. 2024 Dec 30;15(1):10743. doi: 10.1038/s41467-024-53220-6. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Rimiducid | Drug | Dimerizer infusion to activate the iMC of the BPX-601 cells for improved proliferation and persistence |
|
|
| 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 |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| University of Chicago Medicine | Chicago | Illinois | 60637 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| University of Nebraska | Omaha | Nebraska | 68198 | United States |
| John Theurer Cancer Center, Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Duke University | Durham | North Carolina | 27705 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Baylor Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C423866 | AP 1903 reagent |
Not provided
Not provided
Not provided