Trials / Completed
CompletedNCT03441100
TCR-engineered T Cells in Solid Tumors: IMA202-101
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® IMA202-101)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IMA202 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. |
| DEVICE | 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. IMADetect® is intended for investigational use only. |
Timeline
- Start date
- 2019-05-02
- Primary completion
- 2022-06-17
- Completion
- 2023-03-17
- First posted
- 2018-02-22
- Last updated
- 2025-02-04
Locations
6 sites across 2 countries: United States, Germany
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03441100. Inclusion in this directory is not an endorsement.