NCT03247309

TCR-engineered T Cells in Solid Tumors (ACTengine IMA201-101)

Phase 1 Study Evaluating Genetically Modified Autologous T Cells Expressing a T-cell Receptor Recognizing a Cancer/Germline Antigen in Patients With Recurrent and/or Refractory Solid Tumors (ACTengine® IMA201-101)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Immatics US, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study purpose is to establish the safety and tolerability of IMA201 in patients with solid tumors that express melanoma-associated antigen 4 and/or 8 (MAGEA4/8).

Detailed description

SCREENING: Patient eligibility will be determined by HLA (human leukocyte antigen) screening and the biomarkers screening. If the patient is eligible, white blood cells will be taken during leukapheresis for the manufacture of the IMA201 product. MANUFACTURING: IMA201 product will be made from the patient's white blood cells. TREATMENT: Lymphodepletion with cyclophosphamide and fludarabine will occur in the days before the IMA201 infusion to improve the duration of time that IMA201 stays in the body. After IMA201 infusion, a low dose of IL-2 will be given twice daily for a period of time. Patients will be closely monitored for safety and for a total of 3 years post IMA201 infusion.

Conditions

• Solid Tumor
• Cancer
• Recurrent Solid Tumors
• Refractory Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	IMA201 Product	The cell dose will be based on viable CD3+CD8+ HLA-Dextramer+ cells per body surface area (BSA) as defined by the Mosteller formula.
DIAGNOSTIC_TEST	IMADetect®	IMADetect® is developed as a companion diagnostic to aid in selecting patients with relapsed and/or refractory solid cancers who might be eligible for enrollment in clinical trials with investigational IMA201 therapy. IMADetect® is intended for investigational use only.

Timeline

• Start date: 2018-12-19
• Primary completion: 2023-04-20
• Completion: 2023-09-18
• First posted: 2017-08-11
• Last updated: 2025-02-04

Locations

5 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated drug study
• FDA-regulated device study