CART-PSMA- TGFβRDN cells / Gilead - LARVOL DELTA

CART-PSMA-TGFβRDN Cells for Castrate-Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=23 | Active, not recruiting | Sponsor: University of Pennsylvania | Recruiting ➔ Active, not recruiting

Enrollment closed • Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • TGFB1

A Study of CART-PSMA-TGFβRDN in Patients With Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=16 | Terminated | Sponsor: Tmunity Therapeutics | N=50 ➔ 16 | Trial completion date: Nov 2036 ➔ Nov 2022 | Active, not recruiting ➔ Terminated; Based on the safety events and evidence of biologic activity without sustained clinical responses the Sponsor finds the risk/benefit analysis unfavorable for patients and has terminated the study.

CAR T-Cell Therapy • Enrollment change • Metastases • Trial completion date • Trial termination • Gastrointestinal Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Analyses of severe immune-mediated toxicity in patients with advanced mCRPC treated with a PSMA-targeted armored CAR T-cells (SITC 2022) - P1 | "Background We previously reported preliminary safety and efficacy results from a multi-center Phase 1 trial of CART-PSMA-TGFβRDN T-cells (TmPSMA-01; NCT04227275 ) in patients (pts) with metastatic castration resistant prostate cancer (mCRPC)...Knowledge gained from these studies supported the development of a next-generation PSMA-targeting CAR, TmPSMA-02, to improve safety while maintaining anti-tumor activity and will be explored in a multi-center, Ph1/2 trial for pts with mCRPC...The clinical study protocol and the informed consent form (ICF) were both reviewed and approved by the properly chartered IRBs and Independent Ethics Committee before the study commenced. Patients enrolled in the study underwent the appropriate Screening procedures only after providing the appropriate written consent using the approved ICF for this study."

CAR T-Cell Therapy • Clinical • Oncology • Prostate Cancer • CD2 • CSF2 • IL18 • IL2 • IL6 • TGFB1

Safety and early efficacy results from a phase 1, multicenter trial of PSMA-targeted armored CAR T cells in patients with advanced mCRPC. (ASCO-GU 2022) - P1 | "Clinical Trial Registry Number: NCT04227275 Background: CART-PSMA-02 is a multi-center, open-label, phase 1 trial evaluating the safety and feasibility of CART-PSMA-TGFßRDN T-cells (PSMA-CART) in patients (pts) with metastatic castration resistant prostate cancer (mCRPC)... This is a 3+3 dose escalation study to determine the recommended phase 2 dose and schedule of PSMA-CART cells following lymphodepleting chemotherapy (LD) with cyclophosphamide and fludarabine...The trial continued with a modified dose of 0.7-1x108 and the incorporation of prophylactic anakinra (100mg SC daily x7 doses)... PSMA-CART has shown preliminary evidence of biological activity in the absence of clear indications of on-target/off-tumor toxicity. The exact mechanisms driving the severe immune-mediated toxicities in this study are currently unclear. While this study has been closed to further enrollment, ongoing research efforts are aimed at exploring patient specific factors, tumor..."

CAR T-Cell Therapy • Clinical • P1 data • Genito-urinary Cancer • Prostate Cancer • CXCL9 • IL1B • IL2 • IL6

CART-PSMA-TGFβRDN Cells for Castrate-Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=19 | Recruiting | Sponsor: University of Pennsylvania | Active, not recruiting ➔ Recruiting | Trial completion date: Dec 2022 ➔ Dec 2038 | Trial primary completion date: Sep 2022 ➔ Sep 2038

Enrollment open • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • TGFB1

CART-PSMA-TGFβRDN Cells for Castrate-Resistant Prostate Cancer (clinicaltrials.gov) - P1; N=18; Active, not recruiting; Sponsor: University of Pennsylvania; Trial completion date: Sep 2021 ➔ Dec 2022; Trial primary completion date: Sep 2021 ➔ Sep 2022

Clinical • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • TGFB1

[VIRTUAL] PSMA targeted armored chimeric antigen receptor (CAR) T-cells in patients with advanced mCRPC: A phase I experience. (ASCO 2021) - P1 | " This is a 3+3 dose escalation study to determine the recommended phase 2 dose and schedule of CART-PSMA-TGFβRDN cells following lymphodepleting chemotherapy with cyclophosphamide and fludarabine...Ferritin levels peaked at 56,974 ng/ml (baseline 2,903 ng/mL) despite aggressive immunosuppressive therapy including tocilizumab, dexamtheasone and anakinra... Initial data indicates a unique immune toxicity profile and the potential for anti-tumor activity in mCRPC pts treated with CART-PSMA-TGFβRDN . Modified immune toxicity management could lead to identification of a manageable safety profile and therapeutically active dose."

Clinical • P1 data • Anemia • CNS Disorders • Fatigue • Genito-urinary Cancer • Hematological Disorders • Inflammation • Oncology • Prostate Cancer • Solid Tumor • Thrombocytopenia • CD19 • CSF2 • IFNG • IL10 • IL6 • TGFB1 • TNFA

A Study of CART-PSMA-TGFβRDN in Patients With Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - P1; N=50; Recruiting; Sponsor: Tmunity Therapeutics; Active, not recruiting ➔ Recruiting

Clinical • Enrollment open • Gastrointestinal Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CYP17A1

CART-PSMA- TGFβRDN cells: Initiation of P2 trial for mCRPC in Q4 2021 (Tmunity Therapeutics, 39th Annual J.P. Morgan Healthcare Conference (Virtual Meeting))

New P2 trial • Oncology • Prostate Cancer

CART-PSMA- TGFβRDN cells: Initiation of P2 trial for mCRPC in Q4 2021 (Tmunity Therapeutics, 39th Annual J.P. Morgan Healthcare Conference (Virtual Meeting))

New P2 trial • Oncology • Prostate Cancer

CART-PSMA-TGFβRDN Cells for Castrate-Resistant Prostate Cancer (clinicaltrials.gov) - P1; N=18; Active, not recruiting; Sponsor: University of Pennsylvania; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study of CART-PSMA-TGFβRDN in Patients With Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - P1; N=50; Active, not recruiting; Sponsor: Tmunity Therapeutics; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Gastrointestinal Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CYP17A1

CART-PSMA-TGFβRDN Cells for Castrate-Resistant Prostate Cancer (clinicaltrials.gov) - P1; N=18; Recruiting; Sponsor: University of Pennsylvania; Trial primary completion date: Sep 2020 ➔ Sep 2021

Clinical • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor