ACTolog in Patients With Solid Cancers (ACTolog)
|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: NCT02876510|
Recruitment Status : Recruiting
First Posted : August 23, 2016
Last Update Posted : February 8, 2018
In the IMA101-101 study, patients with relapsed and/or refractory solid cancers will be treated with autologous CD8+ T-cell products (IMA101) specific for novel targets from the ACTolog warehouse that have been identified by the XPRESIDENT target discovery platform.
ACTolog is an actively personalized immunotherapy approach in cancer treatment. The ACTolog clinical trial IMA101-101 is a first-in-human trial for the ACTolog concept for patients with advanced stage solid cancers.
The goal of this clinical research study is to learn about the safety of giving IMA101 to patients with advanced cancer. IMA101 is made with T cells (a type of immune cell) that are grown in the laboratory. Researchers also want to learn if IMA101 can help to control the disease.
|Condition or disease||Intervention/treatment||Phase|
|Cancer Solid Tumor||Drug: Fludarabine Drug: Cyclophosphamide Biological: IMA101 T-cell product Biological: Recombinant human interleukin-2 Diagnostic Test: IMA_Detect||Phase 1|
First, patients will enter the screening process.
Screening part 1: Patients may enter the screening procedure when presenting with recurrent/progressing and/or refractory solid cancers when one line of established therapy remains. ACTolog treatment will be applied, if no established treatment is available or treatment is no longer warranted or refused by the patient. During the screening procedures, an HLA test and other medical exams will be done. Only HLA-A*02:01 positive patients can benefit from ACTolog's IMA101 treatment.
Screening part 2: If the patient is HLA-A*02:01 positive and all other initial eligibility criteria are met, a tumor biopsy will then be performed and tested by an investigational diagnostic assay called IMA_Detect. The collected tumor material will be tested for the expression of biomarker targets. At least one of the biomarkers must be positive because expression of these biomarkers indicates the presence of the target structures on the tumor cells against which the study drug will be directed.
If the tumor has none of the specific biomarkers tested by IMA_Detect, the patient will not be eligible for the treatment portion of the study. No further study tests will be done. Only if the patient's tumor has one or more specific biomarkers, and is deemed eligible, may the patient enter the manufacturing phase.
Patients who were biomarker negative in other Immatics' trials, but tested positive for at least one ACTolog biomarker by IMA_Detect may enter screening in order to avoid a new tumor biopsy and repeated biomarker testing.
Manufacturing Phase: During production of the patient's T-cell product, the patient will receive anti-cancer therapy. The leukapheresis product will be made into one to four ACTolog products and frozen until infusion.
Treatment Phase: If the last established therapy option is no longer warranted or refused by the patient, IMA101 T-cell 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 after IMA101 T-cells for 14 days.
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 :||February 28, 2019|
|Estimated Study Completion Date :||August 31, 2019|
Other Name: Fludarabine monophosphate
Other Name: Cytoxan
Biological: IMA101 T-cell 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: Hong Ma, M.D.||firstname.lastname@example.org|
|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.|