TCR-engineered T Cells in Solid Tumors (ACTengine)
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|ClinicalTrials.gov Identifier: NCT03686124|
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : April 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Refractory Cancer Recurrent Cancer Solid Tumor, Adult Cancer||Biological: IMA203 Product Device: IMADetect||Phase 1|
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 treatment.
After the IMA203 product infusion, a low dose of IL-2 will be given subcutaneously twice daily for 14 days.
Since this study involves gene therapy, patients will be monitored throughout the study and for up to a total of 15 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Study Evaluating Genetically Modified Autologous T Cells Expressing a T-cell Receptor Recognizing a Cancer/Germline Antigen in Patients With Relapsed and/or Refractory Solid Tumors (ACTengine IMA203-101)|
|Estimated Study Start Date :||May 2019|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2035|
Experimental: IMA203 Product
Biological: IMA203 Product
Four dose levels (DL) of IMA203 product will be evaluated. The cell dose will be based on viable CD3+CD8+ HLA-Dextramer+ cells per body surface area (BSA) as defined by the Mosteller formula
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 Immatics clinical trials. IMADetect is intended for investigational use only.
- Number of subjects with dose-limiting toxicity (DLT) [ Time Frame: 3 weeks ]
- Number of treatment-emergent adverse events [ Time Frame: up to 12 months ]
- Number of treatment-emergent adverse events of special interest [ Time Frame: up to 12 months ]
- Number of treatment-emergent serious adverse events [ Time Frame: up to 12 months ]
- Recommended Phase 2 Dose (RP2D) [ Time Frame: end of accrual, approximately 12 months ]
- Frequency of TCR engineered T cells within blood T cells [ Time Frame: Up to 12 months ]
- Duration of tumor response [ Time Frame: up to 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03686124
|Contact: Jorge Rivas, M.D.||firstname.lastname@example.org|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Apostolia Tsimberidou, M.D., Ph.D.|
|Principal Investigator:||Apostolia Tsimberidou, M.D., Ph.D.||MDACC, Houston, TX|