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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03132922|
Recruitment Status : Active, not recruiting
First Posted : April 28, 2017
Last Update Posted : August 10, 2022
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|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 Gastroesophageal Junction||Genetic: Autologous genetically modified MAGE-A4ᶜ¹º³²T cells Radiation: Autologous genetically modified MAGE-A4c1032T cells combined with low dose radiation||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||52 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 2032|
|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
|Experimental: Radiation Sub-Study: Autologous genetically modified MAGE-A4c1||
Radiation: Autologous genetically modified MAGE-A4c1032T cells combined with low dose radiation
Up to 10 subjects will be considered for Radiation sub-study. Radiation with an intensity of 1.4Gy for 5 days before infusion of MAGE-A4c1032T cells
- 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
- MAGE-A4c1032T cell trafficking in tumor lesion(s). [ Time Frame: 3.5 years ]Evaluation of post-infusion T-cell trafficking in irradiated vs non-irradiation lesions
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Subject is ≥18 to 75 years of age at the time of signing the study informed consent.
- Subject has histologically confirmed diagnosis of any one of the indicated tumor types
- Subject is HLA-A*02 positive. (This determination will be made under screening protocol ADP-0000-001).
- Subject's tumor shows expression of the MAGE-A4 RNA or protein. (This determination will be made under screening protocol ADP-0000-001).
- Adequate organ function as indicated in the study protocol
- Subject has measurable disease according to RECIST v1.1 criteria prior to lymphodepletion
- Subject meets disease-specific requirements per protocol
7. Subject has anticipated life expectancy > 6 months prior to leukapheresis and >3 months prior to lymphodepletion.
- Subject does not express appropriate HLA-A genotype
- Subject is receiving excluded therapy/treatment per protocol
- Subject has symptomatic CNS metastases.
- Subject has any other active malignancy besides the tumor under study within 3 years prior to Screening. Subject has uncontrolled intercurrent illness.
- Subject has active infection with HIV, HBV, HCV or HTLV
- Subject is pregnant or breastfeeding.
Additional Exclusion Criteria for the Radiation Substudy:
- Subject does not meet eligibility criteria for the main study (ADP-0044-001).
- Subject does not have at least one target lesion amenable to radiation.
- Certain radiation therapy within 6 months of clinical trial are an exclusion.
- Metastatic disease impinging on the spinal cord or threatening spinal cord compression.
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|
|Miami, Florida, United States, 33136|
|Moffitt Cancer Center|
|Tampa, Florida, United States, 33612|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Saint Louis, Missouri, United States, 63112|
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|United States, North Carolina|
|Duke University Medical Center, Duke Cancer Institute|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Ohio State University Wexner Medical Center|
|Columbus, Ohio, United States, 43210|
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111|
|United States, Tennessee|
|Tennessee Oncology - Sarah Cannon Research Institute|
|Nashville, Tennessee, United States, 37203|
|United States, Texas|
|M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Princess Margaret Cancer Centre|
|Toronto, Ontario, Canada, M5G1X6|
|Principal Investigator:||David Hong, MD||M.D. Anderson Cancer Center|
|Other Study ID Numbers:||
|First Posted:||April 28, 2017 Key Record Dates|
|Last Update Posted:||August 10, 2022|
|Last Verified:||August 2022|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
T Cell Therapy
SPEAR T Cell
T Cell Receptor
Squamous, adenosquamous, adenocarcinoma or large cell NSCLC
Squamous or adenocarcinoma esophageal cancer
Urinary Bladder Neoplasms
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms, Connective and Soft Tissue
Digestive System Neoplasms
Digestive System Diseases
Head and Neck Neoplasms
Urinary Bladder Diseases
Neoplasms, Adipose Tissue
Neoplasms, Connective Tissue