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 : December 29, 2021
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor Cancer Recurrent Solid Tumors Refractory Solid Tumors||Biological: IMA201 Product Diagnostic Test: IMADetect®||Phase 1|
SCREENING: Patient eligibility will be determined by HLA (human leukocyte antigen) screening and the 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 :||22 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: 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 with investigational IMA201 therapy. IMADetect® is intended for investigational use only.
- Incidence of adverse events (AE) [ Time Frame: up to 3 years post-treatment ]
- Determination of the maximum tolerated dose (MTD) [ Time Frame: until 21 days 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.||firstname.lastname@example.org|
|United States, Illinois|
|University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Michael Bishop, MD 773-702-9297 email@example.com|
|Principal Investigator: Michael Bishop, MD|
|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. 412-623-6132 email@example.com|
|Principal Investigator: Jason Luke, M.D.|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Active, not recruiting|
|Houston, Texas, United States, 77030|
|Universitätsklinikum Bonn, Venusberg-Campus 1||Recruiting|
|Bonn, North Rhine-Westphalia, Germany, 53127|
|Contact +49(0)228-287-17233 firstname.lastname@example.org|
|Contact +49 (0)151 44048451|
|Principal Investigator: Tobias Holderried, MD, PhD|
|Universitätsklinikum Carl Gustav Carus, Fetscherstr. 74||Recruiting|
|Dresden, Saxony, Germany, 01307|
|Contact: Martin Wermke, MD, PhD +49 (0)351 458 7566 Martin.Wermke@uniklinikum-dresden.de|
|Principal Investigator: Martin Wermke, MD, PhD|
|Hamburg, Germany, 20246|
|Contact +49 (0)40 7410 - 52960 email@example.com|
|Contact +49 +49 (0)40 7410 - 52960|
|Principal Investigator: Carsten Bokemeyer, MD, PhD|
|Study Director:||Cedrik Britten, MD, PhD||Immatics US, Inc.|