Clinical trial · Interventional
P-PSMA-101 CAR-T Cells in the Treatment of Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Advanced Salivary Gland Cancers (SGC)
A Phase 1 Dose Escalation and Expanded Cohort Study of P-PSMA-101 in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Advanced Salivary Gland Cancers (SGC)
NCT04249947CI-TRIAL-00086119terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study closed
Summary
Brief summary (as posted)
An open-label, multi-center, single and cyclic ascending dose study of P-PSMA-101 autologous CAR-T cells in patients with mCRPC and SGC.
Conditions
Conditions (17)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acinic Cell Tumor | Acinar Cell Neoplasm | ALIAS | 0.90 |
| Adenoid Cystic Carcinoma | Adenoid Cystic Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Genital Neoplasms, Male | — | UNRESOLVED | — |
| Metastatic Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
| Mucoepidermoid Carcinoma | Mucoepidermoid Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Neoplasms by Histologic Type | — | UNRESOLVED | — |
| Neoplasms by Site | Neoplasm by Site | ONTOLOGY_EXACT | 0.98 |
| Neoplasms, Prostate | Prostate Neoplasm | ONTOLOGY_EXACT |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| P-PSMA-101 CAR-T cells | Biological | — | UNRESOLVED |
| Rimiducid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- P-PSMA-101 CAR-T cells (Single Dose - Part 1a)
- description
- Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following conditioning chemotherapy regimen A. Rimiducid may be administered as indicated.
- interventionNames
- Biological: P-PSMA-101 CAR-T cells
- Drug: Rimiducid
- type
- EXPERIMENTAL
- label
- P-PSMA-101 CAR-T cells (Multiple Dose - Part 1b)
- description
- Cyclic administration of ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following conditioning chemotherapy regimen A. Rimiducid may be administered as indicated.
- interventionNames
- Biological: P-PSMA-101 CAR-T cells
- Drug: Rimiducid
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects ≥18 years of age * Must have a confirmed diagnosis of mCRPC or SGC * Must have measurable disease by RECIST 1.1 or bone only metastases with measurable PSA (≥1 ng/mL) (mCRPC subjects only) * Must have progressed by PCWG3 and/or RECIST 1.1 (mCRPC subjects only) * Must be willing to practice birth control from screening and for 2 years after the last administration of P-PSMA-101 * Must have adequate vital organ function within pre-determined parameters * Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 Exclusion Criteria: * Has inadequate venous access and/or contraindications to leukapheresis * Has an active second malignancy in addition to mCRPC or SGC, excluding low-risk neoplasms such as non-metastatic basal cell or squamous cell skin carcinoma * Has a history of or active autoimmune disease * Has a history of significant central nervous system (CNS) disease, such as stroke or epilepsy * Has an active systemic (viral, bacterial or fungal) infection * Has received anti-cancer medications (excluding GnRH targeted therapies) within 2 weeks of the time of initiating conditioning chemotherapy * Has received immunosuppressive medications (including anti-cancer medications) within 2 weeks of initiating leukapheresis and/or expected to require them while enrolled in the study * Has received systemic corticosteroid therapy within 2 weeks of either the required leukapheresis or is expected to require it during the course of the study * Has CNS metastases or symptomatic CNS involvement * Has a history of significant ocular disease * Has a history of significant liver disease or active liver disease * Has liver metastases (\<5 lesions and maximum diameter \</= 2.5 cm permitted) * Has a history of or known predisposition to HLH or MAS
References
Publications (0)
Data not yet available
No reference posted for this study.