MAGE-A4ᶜ¹º³²T for Multi-Tumor
|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: NCT03132922|
Recruitment Status : Recruiting
First Posted : April 28, 2017
Last Update Posted : February 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Urinary Bladder Cancer Melanoma Head and Neck Cancer Ovarian Cancer Non-Small Cell Lung Cancer Esophageal Cancer Gastric Cancer Synovial Sarcoma Myxoid Round Cell Liposarcoma||Genetic: Autologous genetically modified MAGE-A4ᶜ¹º³²T cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Dose Escalation, Multi-tumor Study to Assess the Safety, Tolerability and Antitumor Activity of Genetically Engineered MAGE-A4ᶜ¹º³²T in HLA-A2+ Subjects With MAGE-A4 Positive Tumors|
|Actual Study Start Date :||May 15, 2017|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2035|
|Experimental: Autologous genetically modified MAGE-A4ᶜ¹º³²T cells||
Genetic: Autologous genetically modified MAGE-A4ᶜ¹º³²T cells
Infusion of autologous genetically modified MAGE-A4ᶜ¹º³²T on Day 1
- Number of subjects with adverse events (AE), including serious adverse events (SAEs). [ Time Frame: 3.5 years ]Determine if treatment with autologous genetically modified T cells (MAGE-A4ᶜ¹º³²T) is safe and tolerable through laboratory assessments including chemistry, hematology and coagulation.
- Determining dose limiting toxicities (DLT) and optimally tolerated dose range [ Time Frame: 3.5 years ]Evaluate DLTs and toxicity assessment using NCI CTCAE.
- Evaluation of persistence of genetically modified T cells. [ Time Frame: 3.5 years ]Evaluation of persistence of genetically modified T cells in the periphery.
- Measurement of RCL in genetically modified T cells. [ Time Frame: 3.5 years ]Evaluation of RCL in subject PBMCs using PCR-based assay.
- Proportion of subjects with a confirmed Complete Response (CR) and/or Partial Response (PR). [ Time Frame: 3.5 years ]Evaluation of the efficacy of the treatment by assessment of the Overall Response Rate according to RECIST v1.1
- Interval between the date of first T cell infusion dose and first documented evidence of CR or PR. [ Time Frame: 3.5 years ]Evaluation of the efficacy of the treatment by assessment of time to first response.
- Interval between the date of first documented evidence of CR or PR until first documented disease progression or death due to any cause. [ Time Frame: 3.5 years ]Evaluation of the efficacy of the treatment by assessment of duration of response.
- Interval between the date of first documented evidence of stable disease (SD) until first documented disease progression or death due to any cause. [ Time Frame: 3.5 years ]Evaluation of the efficacy of the treatment by assessment of duration of stable disease.
- Interval between the date of first T cell infusion and the earliest date of disease, progression or death due to any cause [ Time Frame: 3.5 years ]Evaluation of the efficacy of the treatment by assessment of progression-free survival.
- Interval between the date of first T cell infusion and date of death due to any cause. [ Time Frame: 3.5 years ]Evaluation of the efficacy of the treatment by assessment of overall survival.
- Number and % of subjects having any Long Term Follow Up Adverse Events (AEs) [ Time Frame: 15 years post last treatment (infusion) ]
- New occurrence of any malignancy
- New occurrence or exacerbation of a pre-existing neurologic disorder
- New occurrence or exacerbation of a prior rheumatologic or other autoimmune disorder
- New occurrence of a hematologic disorder
- New occurrence of any opportunistic and/or serious infections
- New occurrence of any unanticipated illness and/or hospitalization deemed related to gene modified cell therapy
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): NCT03132922
|United States, Florida|
|University of Miami||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Nathalie Luis 305-243-7648 email@example.com|
|Contact: Michelle Munevar|
|Principal Investigator: Brian Slomovitz, MD|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Michelle Landeau 314-747-7997 firstname.lastname@example.org|
|Contact: Cheryl Callahan|
|Principal Investigator: Brian Van Tine, M.D.|
|United States, New York|
|Roswell Park Cancer Institute||Recruiting|
|Buffalo, New York, United States, 14263|
|Contact: Amy Whitworth, BSN 716-845-8409 Amy.Whitworth@roswellpark.org|
|Contact: Dawn DePaolo|
|Principal Investigator: Kunle Odunsi, MD, PhD|
|United States, Pennsylvania|
|Fox Chase Cancer Center||Recruiting|
|Philadelphia, Pennsylvania, United States, 19111|
|Contact: Anthony Olszanski, MD, RPh Anthony.Olszanski@FCCC.edu|
|Principal Investigator: Anthony Olszanski, MD, RPh|
|United States, Tennessee|
|Tennessee Oncology - Sarah Cannon Research Institute||Recruiting|
|Nashville, Tennessee, United States, 37203|
|Contact: Matt Walker 615-339-4214 email@example.com|
|Principal Investigator: Melissa Johnson, MD|
|United States, Texas|
|M.D. Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Danxia Ke 713-792-4384 firstname.lastname@example.org|
|Principal Investigator: David Hong, MD|
|Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M5G1X6|
|Contact: Marcus Butler, MD 416-946-4501 ext 5485 TIP@uhn.ca|
|Principal Investigator: Marcus Butler, MD|