Table 3.
Active trials with bispecific T cell engagers (BiTEs) and CAR-T cells in advanced PCa.
| Short trial Title | Trial Phase |
Estimated Enrolment (pts) |
Experimental Therapy | Disease Stage | Required Pretreatment | Primary Endpoint | NCT Number |
|---|---|---|---|---|---|---|---|
| Safety, Tolerability, Pharmacokinetics, and Efficacy of Acapatamab in Subjects With mCRPC | 1 | 288 | Acapatamab, acapatamab + Pembrolizumab, acapatamab + Etanercept Prophylaxis, acapatamab + Cytochrome P450 Cocktail |
mCRPC | ADT, taxane | Safety and tolerability | NCT03792841 |
| A Study of Tarlatamab (AMG 757) in Participants with Neuroendocrine Prostate Cancer | 1b | 60 | Tarlatamab (AMG 757) | Neuroendocrine prostate cancer | 1 line of prior systemic treatment | Safety and tolerability | NCT04702737 |
| Study of AMG 509 in Subjects with Metastatic Castration-Resistant Prostate Cancer | 1 | 110 | AMG 509 | mCRPC | Prior NHA, taxane | Safety and tolerability | NCT04221542 |
| Safety and Efficacy of Therapies for Metastatic Castration-Resistant Prostate Cancer (mCRPC) | 1/2 | 159 | Acapatamab + Enzalutamide, Acapatamab + Abiraterone, Acapatamab + AMG 404 |
mCRPC | Safety and tolerability | NCT04631601 | |
| Study with Bispecific Antibody Engaging T cells, in Patients with Progressive Cancer Diseases With Positive PSCA Marker | 1 | 24 | GEM3PSCA | PSCA expressing cancer including prostate carcinoma | Progressive Disease After Standard Systemic Therapy | MTD Incidence and intensity of AEs DLT |
NCT03927573 |
| CART-PSMA-TGFβRDN Cells for Castrate-Resistant Prostate Cancer | 1 | 18 | CART-PSMA-TGFβRDN | mCRPC | At least 1 NHA | Safety and tolerability | NCT03089203 |
| P-PSMA-101 CAR-T Cells in the Treatment of Subjects With mCRPC and Advanced Salivary Gland Cancers | 1 | 60 | P-PSMA-101 Rimiducid (safety switch activator) may be administered as indicated |
mCRPC | Safety, DLT, efficacy RECIST 1.1 and PCWG3 | NCT04249947 | |
| PSCA-CAR T Cells in Treating Patients with PSCA + mCRPC | 1 | 33 | Autologous Anti-PSCA-CAR-4-1BB/TCRzeta-CD19t-expressing T-lymphocytes | mCRPC | At least 1 NHA | Safety and tolerability Define recommended phase 2 dose |
NCT03873805 |
| Safety and Activity Study of PSCA-Targeted CAR-T Cells (BPX-601) in Subjects with Selected Advanced Solid Tumors | 1/2 | 151 | 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 Rimiducid: Dimerizer infusion to activate the iMC of the BPX-601 cells for improved proliferation and persistence |
mCRPC among others | MTD and/or recommended extension dose of BPX-601 measured by DLT | NCT02744287 | |
| A Study of JNJ-75229414 for Metastatic Castration-Resistant Prostate Cancer Participant | 1 | 60 | KLK2 CAR-T Cells (JNJ-75229414) | mCRPC | At least 1 NHA or one prior chemotherapy | Number and severity of AE, DLT | NCT05022849 |
| Dose-Escalating Trial with UniCAR02-T Cells and PSMA Target Module (TMpPSMA) in Patients with Progressive Disease After Standard Systemic Therapy in Cancers With Positive PSMA Marker | 1 | 35 | UniCAR02-T Cells and PSMA Target Module (TMpPSMA) | mCRPC | Systemic standard therapies | Safety and tolerability, MTD, DLT | NCT04633148 |
Abbreviations: MTD: maximum tolerated dose, AE: adverse event; DLT: dose-limiting toxicity.