ACTolog in Patients With Solid Cancers (ACTolog)
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|ClinicalTrials.gov Identifier: NCT02876510|
Recruitment Status : Recruiting
First Posted : August 23, 2016
Last Update Posted : July 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cancer Solid Tumor||Drug: Fludarabine Drug: Cyclophosphamide Biological: IMA101 product Biological: Recombinant human interleukin-2 Diagnostic Test: IMA_Detect||Phase 1|
SCREENING: Patient eligibility will be determined by HLA (human leukocyte antigen) and the main biomarkers screening. If the patient is eligible, white blood cells will be taken during leukapheresis for the manufacture of the IMA101 product.
MANUFACTURE: IMA101 product will be made from the patient's white blood cells. TREATMENT: IMA101 product will be administered to the patient intravenously after a lymphodepleting pre-conditioning with chemotherapy (fludarabine and cyclophosphamide).
Low-dose IL-2 will be self-administered twice daily after IMA101 product for a period of time.
Patients will be monitored closely throughout the study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Adoptive Cellular Therapy Trial With Endogenous CD8+ T-cells (ACTolog; IMA101) in Patients With Relapsed and/or Refractory Solid Cancers|
|Actual Study Start Date :||June 30, 2017|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||September 2019|
Other Name: Fludarabine monophosphate
Other Name: Cytoxan
Biological: IMA101 product
i.v. infusion of IMA101 product(s).
Biological: Recombinant human interleukin-2
Low dose IL-2 Infusion for two weeks
Diagnostic Test: IMA_Detect
IMA_Detect is a laboratory test that is part of screening used to determine the mRNA expression of ACTolog target source genes in tumor biopsies from solid tumors. IMA_Detect is intended for investigational use only.
- Incidence of adverse events (Safety and tolerability) [ Time Frame: Until end of trial, appr. 2 years ]
- Incidence of successfully manufactured personalized T-cell products per patient (Feasibility of the ACTolog process) [ Time Frame: Until end of trial, appr. 2 years ]
- Peripheral T-cell persistence (assessment of frequency of T-cells over time) [ Time Frame: Until end of trial, appr. 2 years ]
- T-cell functionality as assessed by cellular immunomonitoring [ Time Frame: Until end of trial, appr. 2 years ]
- Incidence of clinical responders [ Time Frame: Until end of trial, appr. 2 years ]
- Description of overall survival (OS) [ Time Frame: Until end of trial, appr. 2 years ]
- Description of progression-free survival (PFS) [ Time Frame: Until end of trial, appr. 2 years ]
- Determine and report the success rate of completely evaluable results of IMA_Detect from all biopsies collected [ Time Frame: Until end of trial, appr. 2 years ]
- Biobanking for tumor and RNA samples for future IMA_Detect validation studies [ Time Frame: Until the end of the trial, appr. 2 years ]
- Biomarker assessment (Descriptive reporting of cellular, serum and tumor biomarker as well as clinical parameters) • Description of effector functions of antigen specific T cells within PBMCs [ Time Frame: Until end of trial, appr. 2 years ]
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): NCT02876510
|Contact: Rebecca Griffith-Eskewemail@example.com|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Apostolia M. Tsimberidou, M.D., Ph.D.|
|Study Director:||Hong Ma, M.D.||Immatics US, Inc.|