Clinical trial · Interventional
Safety and Activity Study of PSCA-Targeted CAR-T Cells (BPX-601) in Subjects With Selected Advanced Solid Tumors
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to a Dose Limiting Toxicity.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
| Metastatic Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BPX-601 | Biological | — | UNRESOLVED |
| Rimiducid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1: Phase 1 Dose Escalation
- 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.
- interventionNames
- Biological: BPX-601
- Drug: Rimiducid
- type
- EXPERIMENTAL
- label
- Arm 2: Phase 2 Dose Expansion
- 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.
- interventionNames
- Biological: BPX-601
- Drug: Rimiducid
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDStein 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. PMID 39737899