TCR-engineered T Cells in Solid Tumors With Emphasis on NSCLC and HNSCC (ACTengine) (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 : October 22, 2019
|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 Diagnostic Test: ACT-HLA||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.
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 Having Solid Tumors Including But Not Limited to Non-small Cell Lung Cancer or Head and Neck Squamous Cell Carcinoma (ACTengineIMA201-101)|
|Actual Study Start Date :||December 19, 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2033|
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.
Diagnostic Test: ACT-HLA
An assay used to determine whether a patient is positive for the allele HLA-A*02:01 or not, and thus is eligible for treatment with an ACTengine adoptive T-cell product.
- Incidence of adverse events (AE) [ Time Frame: up to 15 years post-treatment ]During treatment and treatment observation phases and long term gene safety follow up, AE and SAE will be captured per CTCAE v4.0. AEs and SAEs will be summarized.
- Duration of infused T cells over time (Persistence of T cells) [ Time Frame: Up to 12 months ]Blood samples will be collected at selected time points (pre- and post-IMA201 treatment at set time points) to assess the persistence of IMA201 T-cells in the blood.
- Incidence of infused T cells (Functionality of T cells) [ Time Frame: Up to 12 months ]
- Success Rates of T cell generation (Feasibility of ACTengine approach) [ Time Frame: This endpoint can be evaluated after production of the last patient's specific T-cell product, i.e. after release of the last patient's cell product. Approximately 10 months ]
- Number of subjects with Clinical response [ Time Frame: 12 weeks and 24 weeks post IMA201 infusion ]
- Levels of Blood biomarkers [ Time Frame: until the end of the trial, up to 15 years from last patient treatment ]
- Levels of Tumor biomarkers [ Time Frame: until the end of the trial, up to 15 years from last patient treatment ]
- Rate of successful biomarker tests for tumor samples collected [ Time Frame: This can be evaluated after last patient's enrollment, approximately 12 months ]
- Percentages of patients expressing individual targets [ Time Frame: This can be evaluated after last patient's enrollment, approximately 10 months after start of trial. ]
- Concordance of HLA-A*02:01 Determination assay [ Time Frame: This can be evaluated after last patient's enrollment, approximately 10 months after start of trial. ]
- Overall Survival (OS) will be assessed. [ Time Frame: until the end of the trial, up to 15 years from last patient treatment. ]
- Progression Free Survival (PFS) will be assessed. [ Time Frame: until the end of the trial, up to 15 years from last patient treatment. ]
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, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Study Director:||Stephen Eck, M.D., Ph.D.||Immatics, US|