Spots Global Cancer Trial Database for TCR-engineered T Cells in Solid Tumors: IMA202-101

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Trial Identification

Brief Title: TCR-engineered T Cells in Solid Tumors: IMA202-101

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® IMA202-101)

Study ID: NCT03441100

Conditions

Interventions

IMA202 Product

IMADetect®

Study Description

Brief Summary: The study purpose is to establish the safety and tolerability of IMA202 product in patients with solid tumors that express melanoma-associated antigen 1 (MAGEA1).

Detailed Description: SCREENING: Patient eligibility will be determined by HLA (human leukocyte antigen) screening and a biopsy for biomarker screening. If the patient is eligible, white blood cells will be taken during leukapheresis for the manufacture of the IMA202 product. MANUFACTURING: IMA202 product will be made from the patient's white blood cells. TREATMENT: Lymphodepletion with cyclophosphamide and fludarabine will occur in the days before the IMA202 product infusion to improve the duration of time that IMA202 product stays in the body. The patient will be admitted to the hospital during the treatment. After the IMA202 product 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 IMA202 infusion.