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Bhasin et al. J Transl Genet Genom 2024;8:55-76 https://dx.doi.org/10.20517/jtgg.2023.46 Page 65

Table 2. Immuno-oncology clinical trials in prostate cancer
Trial ID Phase Target Drug Indication Primary endpoint
NCT00836654 II/III EpCAM (BiTE) Catumaxomab (removab) Malignant ascites + EpCAM- DLT, AE profile, ORR
positive tumors
NCT00635596 I EpCAM (BiTE) Solitomab (AMG110/MT110) Relapsed/refractory solid DLT, AE profile
tumors
NCT01723475 I PSMA (BiTE) Pasotuxizumab (AMG212/BAY2010 mCRPC MTD, DLT, AE profile
112)
NCT03792841 I PSMA (BiTE) Acapatamab (AMG160 (HLE)) mCRPC DLT, AE profile
NCT04631601 I/II PSMA (BiTE) Acapatamab (AMG160 (HLE)) mCRPC DLT, AE profile
NCT02262910 I PSMA (BiTE) ES414 (MOR209/APVO411) mCRPC MTD, DLT
NCT03577028 I PSMA (BiTE) HPN424 mCRPC DLT, ORR
NCT03926013 I PSMA (BiTE) JNJ-63898081 (JNJ-081) mCRPC DLT, AE profile
NCT05441501 I PSMA (BiTE) JNJ-80038114 mCRPC DLT, AE profile
NCT04104607 I PSMA (BiTE) CC-1 mCRPC AE profile
NCT04077021 I PSMA (BiTE) CCW702 mCRPC DLT, AE profile, ORR
NCT05125016 I/II PSMA (BiTE) REGN4336 mCRPC DLT, AE profile, ORR
NCT03972657 I/II PSMA (BiTE) REGN5678 mCRPC, clear cell RCC MTD, DLT, AE profile,
ORR
NCT04740034 I PSMA (BiTE) AMG340 (TNB585) mCRPC MTD, DLT, AE profile
NCT06095089 I PSMA/KLK2 (BiTE) JNJ-87189401 + JNJ-78278343 mCRPC DLT, AE profile, ADA
development, ORR,
NCT05369000 I/IIa PSMA (gammabody LAVA-1207 mCRPC DLT, AE profile
BiTE)
NCT04839991 I PSMA CB307 mCRPC MTD, DLT, AE profile
(Trispecific T-cell
enhancer BiTE)
NCT04227275 I/IIa PSMA (CAR-T) CAR-T PSMA-TGF RDN cells mCRPC DLT, AE profile, ORR
NCT01140373 I PSMA (CAR-T) Autologous anti- PSMA CAR-T cells mCRPC DLT, AE profile
NCT03089203 I PSMA (CAR-T) CAR-T PSMA-TGF RDN cells mCRPC AE profile, T-cell
expansion
NCT04249947 I PSMA (CAR-T) P-PSMA-101 CAR-T cells mCRPC DLT, AE profile, ORR
NCT04429451 I/II PSMA (CAR-T) 4SCAR-PSMA T-cells PSMA positive tumors DLT, AE profile
NCT04633148 I PSMA (CAR-T) UniCAR02 T-cells mCRPC MTD, DLT, AE profile
NCT04768608 I PSMA/PD1 (CAR-T) PD1-PSMA CAR-T cells mCRPC DLT, AE profile
NCT05354375 I PSMA (CAR-T) Anti-PSMA CAR-T cells mCRPC DLT, AE profile, ORR
NCT05489991 I/II PSMA (CAR-T) TmPSMA-02 (dual armored CAR-T mCRPC DLT, AE profile, ORR
cells)
NCT05656573 I PSMA (CAR-T) Anti-PSMA CAR-T cells mCRPC DLT, AE profile
NCT03692663 I PSMA (CAR- NK) Anti-PSMA CAR mCRPC DLT, AE profile
NK cells (TABP EIC)
NCT04053062 I PSMA (CAR-T) LIGHT-PSMA-CAR-T mCRPC AE profile
NCT03927573 I PSCA (BITE) GEM3PSCA Prostate cancer, NSCLC, renal MTD, DLT, AE profile
cancer
NCT03873805 I PSCA (CAR-T) Autologous anti- PSCA-CAR4- mCRPC DLT, AE profile
1BB/TCRzeta- CD19t-expressing T-
lymphocytes
NCT05805371 I PSCA (CAR-T) Autologous anti- PSCA-CAR-4- mCRPC DLT, AE profile
1BB/TCRzeta- CD19t-expressing T-
lymphocytes
NCT05732948 I PSCA/PSMA/P D-1 Anti-PD-1/silent PSMA/PSCA targeted mCRPC DLT, AE profile
(CAR-T) T-cells
NCT02744287 I/II PSCA (CAR-T) BPX-601 mCRPC MTD, DLT, AE profile
NCT04432649 I/II B7-H3 (CAR-T) 4SCAR-276 Recurrent/Refractory B7-H3- AE profile
positive solid tumors
NCT05515185 I B7-H3 (CAR-T) Anti-B7-H3 CAR-T cells Recurrent/Refractory B7-H3- Unknown
positive solid tumors