TCR-engineered T Cells in Solid Tumors (ACTengine IMA201-101) (ACTengine)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03247309|
Recruitment Status : Recruiting
First Posted : August 11, 2017
Last Update Posted : September 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor Cancer Head and Neck Squamous Cell Carcinoma Non-small Cell Lung Cancer||Biological: IMA201 Product Diagnostic Test: IMA_Detect||Phase 1|
SCREENING: Patient eligibility will be determined by HLA (human leukocyte antigen) screening and the main 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 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 Recurrent and/or Refractory Solid Tumors (ACTengine® IMA201-101)|
|Actual Study Start Date :||December 19, 2018|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2024|
Experimental: IMA201 Product
Biological: IMA201 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.
Diagnostic Test: IMA_Detect
IMA_Detect 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 with investigational IMA201 therapy. IMA_Detect is intended for investigational use only.
- Incidence of adverse events (AE) [ Time Frame: up to 3 years post-treatment ]
- Duration of infused T cells over time (Persistence of T cells) [ Time Frame: up to 3 years post-treatment ]
- Tumor response per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 and immune-related RECIST (irRECIST) [ 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): NCT03247309
|Contact: Jorge Rivas, M.D., Ph.D.||email@example.com|
|United States, New York|
|Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Contact 212-342-5162 firstname.lastname@example.org|
|Principal Investigator: Ran Reshef, MD|
|United States, Pennsylvania|
|University of Pittsburgh Medical Center||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15232|
|Contact: Jason Luke, M.D.|
|Principal Investigator: Jason Luke, M.D.|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Study Director:||Cedrik Britten, M.D.||Immatics, US|