TCR-engineered T Cells in Solid Tumors: IMA202-101 (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: NCT03441100|
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : September 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor, Adult Cancer Hepatocellular Carcinoma Hepatocellular Cancer Nonsmall Cell Lung Cancer Liver Cancer Lung Cancer||Drug: IMA202 Product Device: 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 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.
|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® IMA202-101)|
|Actual Study Start Date :||May 2, 2019|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2024|
Experimental: Experimental: IMA202 Product
Drug: IMA202 Product
Four dose levels (DL) of IMA202 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.
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. IMA_Detect is intended for investigational use only.
- Incidence of adverse events (AE) [ Time Frame: up to 3 years post treatment ]
- 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): NCT03441100
|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|
|Contact: Apostolia Tsimberidou, M.D.,Ph.D.|
|Würzburg, Bavaria, Germany, 97080|
|Contact +49 931 201 0|
|Contact +49 931 201 40953|
|Principal Investigator: Manik Chatterjee, MD, PhD|
|Universitätsklinikum Bonn - Medizinische Klinik III||Recruiting|
|Bonn, North Rhine-Westphalia, Germany, 53127|
|Contact +49 (0) 228 2870|
|Contact +49 228 287 17233|
|Principal Investigator: Tobias Holderried, MD, PhD|
|Universitätsklinikum C.-G.-Carus Dresden||Recruiting|
|Dresden, Saxony, Germany, 01307|
|Contact +49 351 458 7566|
|Principal Investigator: Martin Wermke, MD, PhD|
|Study Director:||Cedrik Britten, M.D.||Immatics US, Inc.|
|Principal Investigator:||Apostolia Tsimberidou, M.D., Ph.D.||M.D. Anderson Cancer Center|