Spots Global Cancer Trial Database for TCR-engineered T Cells in Solid Tumors (ACTengine IMA201-101)

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Trial Identification

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

Official Title: 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)

Study ID: NCT03247309

Conditions

Solid Tumor

Cancer

Recurrent Solid Tumors

Refractory Solid Tumors

Interventions

IMA201 Product

IMADetect®

Study Description

Brief 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.