TCR-engineered T Cells in Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 16
Summary
- Conditions
- Cancer
- Recurrent Cancer
- Refractory Cancer
- Solid Tumor, Adult
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 IMA203 product. MANUFACTURING: IMA203 product will be made fr...
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 IMA203 product. MANUFACTURING: IMA203 product will be made from the patient's white blood cells. TREATMENT: Lymphodepletion with cyclophosphamide and fludarabine will occur in the days before the IMA203 product infusion to improve the duration of time that IMA203 product stays in the body. The patient will be admitted to the hospital during the T-cell infusion. After the IMA203 product infusion, a low dose of IL-2 will be given subcutaneously twice daily for 14 days. In group 2, atezolizumab will be administered every 4 weeks. Patients will be monitored closely throughout the study. The treatment and observation phase ends 3 years post infusion.
Tracking Information
- NCT #
- NCT03686124
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Apostolia Tsimberidou, M.D., Ph.D. MDACC, Houston, TX Study Director: Cedrik Britten, M.D. Immatics US, Inc.
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