NCT05028933

IMC001 for Clinical Research on Advanced Digestive System Malignancies

Autologous T Cells Modified by Chimeric Antigen Receptor Targeting EpCAM for Clinical Research on Advanced Digestive System Malignancies

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A Phase I Clinical Study of Autologous T cells modified with chimeric antigen receptor targeting EpCAM ( EPCAM CAR-T) in Patients with malignant tumors of the digestive system (including advanced gastric cancer, colorectal cancer, liver cancer and pancreatic cancer) .

Detailed description

This is a phase I open-label, single and multiple infusion, dose escalation/cohort expansion study to evaluate the safety, cell pharmacokinetics, and preliminary efficacy of EPCAM CAR-T, infused intravenously in subjects who have been diagnosed with advanced malignant tumors of the digestive system (including advanced gastric cancer, colorectal cancer, liver cancer and pancreatic cancer) and refractory or intolerant to current standard systemic treatment. Primary objectives: •To evaluate the safety and tolerability of EPCAM CAR-T infused intravenously at escalating doses in patients with advanced malignant tumors of the digestive system. Secondary objectives: 1. The treatment of EpCAM CAR-T for patients with advanced digestive system malignancies, according to the dose-limiting toxicity and clinical response, including Possible side effects, determine the maximum tolerated dose (MTD), extended recommended dose (RDE) and/or recommended phase II dose (RP2D). 2. Assess the correlation between the pharmacodynamic (PD) biomarkers of IMC001 and clinical efficacy; EpCAM CAR-T expands and persists in vivo Correlation between sexual and pharmacodynamic (PD) biomarkers and adverse events. 3. To evaluate the preliminary anti-tumor efficacy of EpCAM CAR-T in patients with advanced digestive system malignancies. According to the evaluation criteria for the efficacy of solid tumors (RECIST) Version V.1.1, Evaluation Criteria for Efficacy of Immunotherapy for Solid Tumors (iRECIST), using objective response rate(ORR), duration of remission (DOR), disease control rate (DCR) and progression-free survival (PFS) description preliminary Anti-tumor activity. 4. The incidence of treatment-related adverse events. Exploratory purpose: 1. Assess changes in immune status of EPCAM CAR-T treatment. 2. Assess the change of CTC in the peripheral blood of patients and the clearance effect of CAR-T cell treatment on CTC.

Conditions

• Advanced Hepatocellular Carcinoma
• Advanced Colorectal Cancer
• Advanced Gastric Cancer
• Advanced Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	EPCAM CAR-T	Pretreatment with fludarabine and cyclophosphamide EpCAM CAR-T Cells infusion

Timeline

• Start date: 2021-09-30
• Primary completion: 2024-12-30
• Completion: 2024-12-31
• First posted: 2021-08-31
• Last updated: 2024-02-12

Locations

2 sites across 1 country: China