C-13-60 / Chongqing Precision Biotech - LARVOL DELTA

Phase I trial of hypoxia-responsive CEA CAR-T cell therapy in patients with heavily pretreated solid tumor via intraperitoneal or intravenous transfusion. (ASCO 2024) - P1 | "The CEA CAR-T cell therapy had acceptable toxicity via I.P. or I.V. infusion. We have observed a promising antitumor potential by I.P. infusion and a prolonged tumor remission in high-dose group. Further investigation is needed to highlight these findings and the corresponding mechanisms."

CAR T-Cell Therapy • Clinical • P1 data • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Immunology • Lung Cancer • Mucositis • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Hypoxia-responsive CEA CAR-T cells therapy for relapsed or refractory non-small cell lung cancer: A single-arm, open-label, phase I trial. (ASCO 2025) - "A single infusion of hypoxia-responsive CEA CAR-T demonstrated promising efficacy and manageable safety in r/r NSCLC. The findings highlight the potential role of specific NK cell states and immune interactions in the therapeutic effects of CEA CAR-T therapy. Clinical response at different doses.Data are n (%)."

CAR T-Cell Therapy • Clinical • IO biomarker • P1 data • Infectious Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD8 • HLA-DRB1

PBC039: A Clinical Study of CEA-targeted CAR-T in the Treatment of CEA-positive Advanced Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=58 | Completed | Sponsor: Weijia Fang, MD | Recruiting ➔ Completed | N=110 ➔ 58 | Trial completion date: Dec 2027 ➔ Jun 2026 | Trial primary completion date: Dec 2027 ➔ Jun 2026

Enrollment change • IO biomarker • Trial completion • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastric Cancer • Oncology • Solid Tumor

Safety and Efficacy of CEA-targeted CAR-T for CEA-positive Advanced Malignant Solid Tumors (clinicaltrials.gov) - P1/2 | N=17 | Completed | Sponsor: Chongqing Precision Biotech Co., Ltd | Recruiting ➔ Completed | N=60 ➔ 17

Enrollment change • Trial completion • Colon Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Oncology • Pancreatic Cancer • Rectal Cancer • Solid Tumor

Safety and Efficacy of CEA-Targeted CAR-T Therapy for Relapsed/Refractory CEA+ Cancer (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: Chongqing Precision Biotech Co., Ltd | N=40 ➔ 0 | Recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Breast Cancer • Colorectal Cancer • Estrogen Receptor Positive Breast Cancer • Gastric Cancer • Liver Cancer • Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: Chongqing Precision Biotech Co., Ltd | Recruiting ➔ Completed

IO biomarker • Trial completion • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Oncology • Pancreatic Cancer • Solid Tumor

PBC039: A Clinical Study of CEA-targeted CAR-T in the Treatment of CEA-positive Advanced Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=110 | Recruiting | Sponsor: Weijia Fang, MD | Completed ➔ Recruiting | N=43 ➔ 110 | Trial completion date: Jun 2024 ➔ Dec 2027 | Trial primary completion date: Jun 2024 ➔ Dec 2027

Enrollment change • Enrollment open • IO biomarker • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastric Cancer • Oncology • Solid Tumor

Hypoxia-responsive CEA-targeted CAR T cells in CEA-positive solid tumors through intraperitoneal or intravenous infusion: a phase 1 trial. (PubMed, Nat Cancer) - P1 | "The predefined safety endpoint was met. PC13 demonstrated manageable toxicity and promising efficacy, supporting further investigations."

Journal • P1 data • Oncology • Solid Tumor • CEACAM5

CEA CAR-T Therapy After Cytoreduction in Colorectal Cancer Patients With Peritoneal Metastases (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

New P1 trial • Colorectal Cancer • Oncology • Solid Tumor

PBC102: A Study of CEA-Targeted CAR-T Therapy in Patients With CEA-Positive Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

New P1 trial • Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

CEA-Targeted CAR-T Therapy in CEA-Positive Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=108 | Recruiting | Sponsor: Chongqing Precision Biotech Co., Ltd

New P1 trial • Colon Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Lung Cancer • Oncology • Pancreatic Cancer • Rectal Cancer • Solid Tumor

Intraperitoneal administration of anti-CEA CAR-T cells as an effective treatment for colorectal cancer–derived peritoneal carcinomatosis in a preclinical model (ESCP 2025) - "Conclusion Our study indicates that intraperitoneal administration of CAR-T cells provides an effective, safe, and prolonged anti-tumor activity providing protection against tumor recurrence, and a robust route for colorectal PC therapy with metastasis in intraperitoneal and extraperitoneal organs. This route is superior even without PC."

CAR T-Cell Therapy • Preclinical • Colorectal Cancer • Hematological Malignancies • Oncology • Peritoneal Cancer • Solid Tumor

Study of CEA Targeting CAR-T (PTC13) in the Treatment of CEA-Positive Advanced Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Weijia Fang, MD | N=50 ➔ 18

Enrollment change • IO biomarker • Colorectal Cancer • Gastric Cancer • Oncology • Pancreatic Cancer • Solid Tumor

HYPOXIA-RESPONSIVE CEA CAR-T CELLS THERAPY FOR RELAPSED STAGE IV NON-SMALL CELL LUNG CANCER: A SINGLE-ARM, OPEN-LABEL, PHASE I TRIAL (EHA 2025) - P1/2 | "A single infusion of hypoxia-responsive CEA CAR-T demonstrated promising efficacy and manageable safety in relapsed stage IV NSCLC. The findings highlight the potential role of specific NK cell states and immune interactions in the therapeutic effects of CEA CAR-T therapy."

CAR T-Cell Therapy • Clinical • IO biomarker • Metastases • P1 data • Inherited Retinal Dystrophy • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ophthalmology • Solid Tumor • DUSP1 • HLA-C • HLA-DRB1 • HSPB1 • TGFB1

CAR-T Therapy Targeting CEA in Advanced CEA-Positive Lung Cancer (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Chongqing Precision Biotech Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • IO biomarker • Lung Cancer • Oncology • Solid Tumor

CAR-T Therapy Targeting CEA in Advanced CEA-Positive Lung Cancer (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Chongqing Precision Biotech Co., Ltd

IO biomarker • New P1 trial • Lung Cancer • Oncology • Solid Tumor

PBC039: A Clinical Study of CEA-targeted CAR-T in the Treatment of CEA-positive Advanced Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=43 | Completed | Sponsor: Weijia Fang, MD | Active, not recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Jun 2024

IO biomarker • Trial completion • Trial completion date • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

Study of CEA Targeting CAR-T in the Treatment of CEA-Positive Advanced Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Weijia Fang, MD | N=72 ➔ 50

Enrollment change • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

PBC039: A Clinical Study of CEA-targeted CAR-T in the Treatment of CEA-positive Advanced Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=60 | Active, not recruiting | Sponsor: Weijia Fang, MD | Recruiting ➔ Active, not recruiting | Trial completion date: May 2025 ➔ Dec 2025

Enrollment closed • IO biomarker • Trial completion date • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CEACAM5

Study of CEA Targeting CAR-T in the Treatment of CEA-Positive Advanced Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: Weijia Fang, MD

New P1 trial • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CEACAM5

A Clinical Trial of CEA Targeting CAR-T for CEA Positive Advanced Lung Cancer (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Chongqing Precision Biotech Co., Ltd

IO biomarker • New P1 trial • Lung Cancer • Oncology • Solid Tumor

Intraperitoneal administration of carcinoembryonic antigen-directed chimeric antigen receptor T cells is a robust delivery route for effective treatment of peritoneal carcinomatosis from colorectal cancer in pre-clinical study. (PubMed, Cytotherapy) - "Taken together, our data suggest that i.p. administration of CAR T cells may be a robust delivery route for effective treatment of cancer."

CAR T-Cell Therapy • Journal • Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Hematological Disorders • Hematological Malignancies • Hepatology • Oncology • Pancreatic Cancer • Peritoneal Cancer • Solid Tumor • CEACAM5 • PSCA

Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Chongqing Precision Biotech Co., Ltd | Trial completion date: Sep 2024 ➔ Sep 2025 | Trial primary completion date: Sep 2023 ➔ Sep 2024

IO biomarker • Metastases • Trial completion date • Trial primary completion date • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CEACAM5

Clinical Study of CEA Targeting Chimeric Antigen Receptor T Lymphocytes（CAR-T） for CEA Positive Advanced Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Chongqing Precision Biotech Co., Ltd

Metastases • New P1 trial • Biliary Cancer • Breast Cancer • Cholangiocarcinoma • Colon Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Hepatology • Lung Cancer • Oncology • Pancreatic Cancer • Rectal Cancer • Solid Tumor

Hypoxia-responsive CAR-T cells exhibit reduced exhaustion and enhanced efficacy in solid tumors. (PubMed, Cancer Res) - "Furthermore, 5H1P-CEA CAR-T cells exhibited decreased T cell exhaustion and improved T cell phenotype in vivo. In patient-derived xenograft models, hypoxia-responsive CAR-T cells induced more durable antitumor activity than their conventional counterparts. Overall, this study provides an approach to limit CAR expression to the hypoxic tumor microenvironment that could help to enhance CAR-T cell efficacy and safety in solid tumors."

CAR T-Cell Therapy • IO biomarker • Journal • Oncology • Solid Tumor