TCR-engineered T Cells in Solid Tumors Including NSCLC and HCC Patients (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 21, 2018
Last Update Posted : October 5, 2018
|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.
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 I Trial Evaluating Genetically Modified Autologous T Cells Expressing a T-cell Receptor Recognizing a Cancer/Germline Antigen in Patients With Solid Tumors Including But Not Limited to NSCLC or HCC|
|Estimated Study Start Date :||October 2018|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||June 2033|
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.
- Number of subjects with dose-limiting toxicity (DLT) and adverse events (AE) [ Time Frame: 6 months to 18 months ]
- Assessment of tumor responses and progression based on RECIST 1.1 and immune-related RECIST (irRECIST). [ Time Frame: 12 and 24 weeks after the infusion of IMA202 product ]
- Success rate of IMA202 product generation [ Time Frame: 12 months ]
- Duration of infused IMA202 product over time [ Time Frame: 12 months ]
- Incidence of infused IMA202 product [ Time Frame: 12 months ]
- Blood based assessment to evaluate the mechanisms of action of IMA202 product [ Time Frame: 24 months ]
- Blood based assessment to evaluate the pharmacodynamics of IMA202 product [ Time Frame: 24 months ]
- Assessment of tumor biomarker expression levels [ Time Frame: 24 months ]
- Assessment of T-cell infiltration [ Time Frame: 24 months ]
- Rate of successful biomarker tests for tumor samples collected [ Time Frame: 24 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: Rebecca Griffith-Eskewemail@example.com|
|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, Inc.|