gene-modified anti-CEA T cells / Roger Williams Medical Center, Sorrento - LARVOL DELTA

HITM-SIR: Phase Ib trial of CAR-T hepatic artery infusions and selective internal radiation therapy for liver metastases (AACR 2017) - "In the previous Hepatic Immunotherapy for Metastases (HITM) phase I study we demonstrated the safety and biologic activity of anti-CEA CAR-T cell hepatic artery infusions (HAI). Following this phase Ib trial, the recommended phase 2 dose for anti-CEA CAR-T HITM infusions is 1010 cells with or without SIRT. The favorable safety profile and evidence of biologic activity indicate that CAR-T HITM infusions should be further studied in a phase 2 trial."

CAR T-Cell Therapy • Clinical • P1 data • P2/3 data • P3 data • Biosimilar • Immunology • Oncology

CAR-T Intraperitoneal Infusions for CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites (IPC) (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Sorrento Therapeutics, Inc. | N=18 ➔ 0 | Active, not recruiting ➔ Withdrawn

CAR T-Cell Therapy • Enrollment change • Trial withdrawal • Breast Cancer • Colorectal Cancer • Embryonal Tumor • Gastric Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Peritoneal Cancer • Solid Tumor • CEACAM5

Study of Anti-CEA CAR-T + Chemotherapy VS Chemotherapy Alone in Patients With CEA+Pancreatic Cancer & Liver Metastases (clinicaltrials.gov) - P2b | N=0 | Withdrawn | Sponsor: Sorrento Therapeutics, Inc. | N=167 ➔ 0 | Not yet recruiting ➔ Withdrawn

CAR T-Cell Therapy • Enrollment change • Trial withdrawal • Gastrointestinal Cancer • Hepatology • Lung Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CEACAM5

AntiCEA_CART: Phase 1b Study of CAR2Anti-CEA CAR-T Cell Hepatic Infusions for Pancreatic Carcinoma Patients With CEA+ Liver Metastases (clinicaltrials.gov) - P1b | N=2 | Terminated | Sponsor: Sorrento Therapeutics, Inc. | Trial completion date: Feb 2022 ➔ Jun 2021 | Active, not recruiting ➔ Terminated | Trial primary completion date: Feb 2021 ➔ Jun 2021; Limited enrollment.

CAR T-Cell Therapy • Trial completion date • Trial primary completion date • Trial termination • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

HITM-SURE: CAR-T Hepatic Artery Infusions or Pancreatic Venous Infusions for CEA-Expressing Liver Metastases or Pancreas Cancer (clinicaltrials.gov) - P1; N=5; Completed; Sponsor: Roger Williams Medical Center; Active, not recruiting ➔ Completed; Trial completion date: Feb 2021 ➔ Sep 2021

Trial completion • Trial completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CEACAM5 • MRI

HITM-SURE: Phase Ib CAR-T hepatic artery infusion trial for stage IV adenocarcinoma using PressureEnabled Drug Delivery technology (SITC 2018) - P1; "Trial Registration NCT02850536; Background Prior Hepatic Immunotherapy for Metastases (HITM) phase I/Ib studies demonstrated the safety and biologic activity of anti-CEA CAR-T cell hepatic artery infusions (HAI) for CEA+ liver metastases (LM). The median OS compares favorably with prior HITM studies and presently approved second/third line regimens. Final results will inform design and device choice for larger studies."

IO biomarker • P1 data • PD(L)-1 Biomarker • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Pancreatic Cancer • Solid Tumor

HITM: CEA-Expressing Liver Metastases Safety Study of Intrahepatic Infusions of Anti-CEA Designer T Cells (clinicaltrials.gov) - P1; N=8; Completed; Sponsor: Roger Williams Medical Center; Recruiting ➔ Completed

Clinical • Trial completion • Oncology • CEACAM5 • MRI

Study of Anti-CEA CAR-T + Chemotherapy VS Chemotherapy Alone in Patients With CEA+Pancreatic Cancer & Liver Metastases (clinicaltrials.gov) - P2b; N=167; Not yet recruiting; Sponsor: Sorrento Therapeutics, Inc.; Initiation date: Nov 2019 ➔ Nov 2021

Clinical • Trial initiation date • Gastrointestinal Cancer • Hepatology • Lung Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CEACAM5

HITM-SURE: CAR-T Hepatic Artery Infusions or Pancreatic Venous Infusions for CEA-Expressing Liver Metastases or Pancreas Cancer (clinicaltrials.gov) - P1; N=5; Active, not recruiting; Sponsor: Roger Williams Medical Center; Trial completion date: Dec 2019 ➔ Aug 2020

Trial completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CEACAM5 • MRI

Study of Anti-CEA CAR-T + Chemotherapy VS Chemotherapy Alone in Patients With CEA+Pancreatic Cancer & Liver Metastases (clinicaltrials.gov) - P2b; N=167; Not yet recruiting; Sponsor: Sorrento Therapeutics, Inc.

Clinical • New P2b trial • Gastrointestinal Cancer • Hepatology • Lung Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CEACAM5

HITM-SURE: CAR-T Hepatic Artery Infusions or Pancreatic Venous Infusions for CEA-Expressing Liver Metastases or Pancreas Cancer (clinicaltrials.gov) - P1; N=5; Recruiting; Sponsor: Roger Williams Medical Center; Trial completion date: Dec 2017 ➔ Aug 2018; Trial primary completion date: Dec 2017 ➔ Aug 2018

Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CEACAM5 • MRI

HITM-SURE: CAR-T Hepatic Artery Infusions or Pancreatic Venous Infusions for CEA-Expressing Liver Metastases or Pancreas Cancer (clinicaltrials.gov) - P1; N=5; Active, not recruiting; Sponsor: Roger Williams Medical Center; Recruiting ➔ Active, not recruiting

Enrollment closed • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CEACAM5 • MRI

HITM-SIR: CAR-T Hepatic Artery Infusions and Sir-Spheres for Liver Metastases (clinicaltrials.gov) - P1; N=8; Active, not recruiting; Sponsor: Roger Williams Medical Center; Trial completion date: Sep 2017 ➔ Jan 2019

Trial completion date • Hepatology • Oncology • CEACAM5 • MRI

HITM-SURE: CAR-T Hepatic Artery Infusions or Pancreatic Venous Infusions for CEA-Expressing Liver Metastases or Pancreas Cancer (clinicaltrials.gov) - P1; N=5; Active, not recruiting; Sponsor: Roger Williams Medical Center; Trial completion date: Aug 2018 ➔ Dec 2019; Trial primary completion date: Aug 2018 ➔ Dec 2018

Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CEACAM5 • MRI

HITM-SIR: CAR-T Hepatic Artery Infusions and Sir-Spheres for Liver Metastases (clinicaltrials.gov) - P1; N=8; Completed; Sponsor: Roger Williams Medical Center; Active, not recruiting ➔ Completed; Trial completion date: Jan 2019 ➔ Jun 2018

Trial completion • Trial completion date • Hepatology • Oncology • CEACAM5 • MRI

HITM-SIR: CAR-T Hepatic Artery Infusions and Sir-Spheres for Liver Metastases (clinicaltrials.gov) - P1; N=8; Active, not recruiting; Sponsor: Roger Williams Medical Center; Recruiting ➔ Active, not recruiting; Trial primary completion date: Sep 2016 ➔ Dec 2016

Enrollment closed • Trial primary completion date • Hepatology • Oncology • CEACAM5 • MRI

HITM-SURE: CAR-T Hepatic Artery Infusions or Pancreatic Venous Infusions for CEA-Expressing Liver Metastases or Pancreas Cancer (clinicaltrials.gov) - P1; N=5; Not yet recruiting; Sponsor: Roger Williams Medical Center

New P1 trial • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CEACAM5 • MRI

HITM-SURE: CAR-T Hepatic Artery Infusions or Pancreatic Venous Infusions for CEA-Expressing Liver Metastases or Pancreas Cancer (clinicaltrials.gov) - P1; N=5; Not yet recruiting; Sponsor: Roger Williams Medical Center; Initiation date: Aug 2016 ➔ Dec 2016

Trial initiation date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CEACAM5 • MRI

HITM-SURE: CAR-T Hepatic Artery Infusions or Pancreatic Venous Infusions for CEA-Expressing Liver Metastases or Pancreas Cancer (clinicaltrials.gov) - P1; N=5; Recruiting; Sponsor: Roger Williams Medical Center; Not yet recruiting ➔ Recruiting; Trial primary completion date: Aug 2017 ➔ Dec 2017

Enrollment open • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CEACAM5 • MRI

HITM-SIR: CAR-T Hepatic Artery Infusions and Sir-Spheres for Liver Metastases (clinicaltrials.gov) - P1; N=8; Active, not recruiting; Sponsor: Roger Williams Medical Center; Trial primary completion date: Dec 2016 ➔ Sep 2017

Trial primary completion date • Hepatology • Oncology • CEACAM5 • MRI

HITM-SIR: CAR-T Hepatic Artery Infusions and Sir-Spheres for Liver Metastases (clinicaltrials.gov) - P1; N=6; Recruiting; Sponsor: Roger Williams Medical Center; Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology • Oncology • CEACAM5 • MRI

HITM-SIR: CAR-T Hepatic Artery Infusions and Sir-Spheres for Liver Metastases (clinicaltrials.gov) - P1; N=6; Not yet recruiting; Sponsor: Roger Williams Medical Center

New P1 trial • Hepatology • Oncology • CEACAM5 • MRI

HITM-SIR: CAR-T Hepatic Artery Infusions and Sir-Spheres for Liver Metastases (clinicaltrials.gov) - P1; N=6; Recruiting; Sponsor: Roger Williams Medical Center; Trial primary completion date: Mar 2016 ➔ Sep 2016

Trial primary completion date • Hepatology • Oncology • CEACAM5 • MRI

HITM-SURE: CAR-T Hepatic Artery Infusions or Pancreatic Venous Infusions for CEA-Expressing Liver Metastases or Pancreas Cancer (clinicaltrials.gov) - P1; N=5; Active, not recruiting; Sponsor: Roger Williams Medical Center; Trial completion date: Aug 2020 ➔ Feb 2021

Trial completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CEACAM5 • MRI

CAR-T Intraperitoneal Infusions for CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites (IPC) (clinicaltrials.gov) - P1; N=18; Active, not recruiting; Sponsor: Sorrento Therapeutics, Inc.; Trial completion date: Sep 2020 ➔ Mar 2021; Trial primary completion date: Sep 2020 ➔ Dec 2020

Clinical • Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Embryonal Tumor • Gastric Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Peritoneal Cancer • Solid Tumor • MRI