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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03132922
Other study ID # ADP-0044-001/RSS
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date May 15, 2017
Est. completion date September 2032

Study information

Verified date January 2024
Source Adaptimmune
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will investigate the safety and tolerability of MAGE-A4ᶜ¹º³²T cell therapy in subjects who have the appropriate HLA-A2 tissue marker and whose urinary bladder, melanoma, head and neck, ovarian, non-small cell lung, esophageal, gastric, synovial sarcoma, or myxoid/round call liposarcoma (MRCLS) tumor has the MAGE-A4 protein expressed. This study will take a subject's T cells and give them a T cell receptor protein that recognizes and attacks the tumors. This study has a substudy component that will investigate the safety and tolerability of MAGE-A4c1032T cell therapy in combination with low dose radiation in up to 10 subjects.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 71
Est. completion date September 2032
Est. primary completion date December 27, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. Subject is =18 to 75 years of age at the time of signing the study informed consent. 2. Subject has histologically confirmed diagnosis of any one of the indicated tumor types 3. Subject is HLA-A*02 positive. (This determination will be made under screening protocol ADP-0000-001). 4. Subject's tumor shows expression of the MAGE-A4 RNA or protein. (This determination will be made under screening protocol ADP-0000-001). 5. Adequate organ function as indicated in the study protocol 6. Subject has measurable disease according to RECIST v1.1 criteria prior to lymphodepletion 7. Subject meets disease-specific requirements per protocol 7. Subject has anticipated life expectancy > 6 months prior to leukapheresis and >3 months prior to lymphodepletion. Exclusion Criteria: 1. Subject does not express appropriate HLA-A genotype 2. Subject is receiving excluded therapy/treatment per protocol 3. Subject has symptomatic CNS metastases. 4. Subject has any other active malignancy besides the tumor under study within 3 years prior to Screening. Subject has uncontrolled intercurrent illness. 5. Subject has active infection with HIV, HBV, HCV or HTLV 6. 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.

Study Design


Intervention

Genetic:
Autologous genetically modified MAGE-A4?¹º³²T cells
Infusion of autologous genetically modified MAGE-A4?¹º³²T on Day 1
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

Locations

Country Name City State
Canada Princess Margaret Cancer Centre Toronto Ontario
United States Roswell Park Cancer Institute Buffalo New York
United States Ohio State University Wexner Medical Center Columbus Ohio
United States Duke University Medical Center, Duke Cancer Institute Durham North Carolina
United States M.D. Anderson Cancer Center Houston Texas
United States University of Miami Miami Florida
United States Tennessee Oncology - Sarah Cannon Research Institute Nashville Tennessee
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States Washington University Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Moffitt Cancer Center Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Adaptimmune

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other MAGE-A4c1032T cell trafficking in tumor lesion(s). Evaluation of post-infusion T-cell trafficking in irradiated vs non-irradiation lesions 3.5 years
Primary Number of subjects with adverse events (AE), including serious adverse events (SAEs). Determine if treatment with autologous genetically modified T cells (MAGE-A4?¹º³²T) is safe and tolerable through laboratory assessments including chemistry, hematology and coagulation. 3.5 years
Primary Determining dose limiting toxicities (DLT) and optimally tolerated dose range Evaluate DLTs and toxicity assessment using NCI CTCAE. 3.5 years
Primary Evaluation of persistence of genetically modified T cells. Evaluation of persistence of genetically modified T cells in the periphery. 3.5 years
Primary Measurement of RCL in genetically modified T cells. Evaluation of RCL in subject PBMCs using PCR-based assay. 3.5 years
Secondary Proportion of subjects with a confirmed Complete Response (CR) and/or Partial Response (PR). Evaluation of the efficacy of the treatment by assessment of the Overall Response Rate according to RECIST v1.1 3.5 years
Secondary Interval between the date of first T cell infusion dose and first documented evidence of CR or PR. Evaluation of the efficacy of the treatment by assessment of time to first response. 3.5 years
Secondary Interval between the date of first documented evidence of CR or PR until first documented disease progression or death due to any cause. Evaluation of the efficacy of the treatment by assessment of duration of response. 3.5 years
Secondary Interval between the date of first documented evidence of stable disease (SD) until first documented disease progression or death due to any cause. Evaluation of the efficacy of the treatment by assessment of duration of stable disease. 3.5 years
Secondary Interval between the date of first T cell infusion and the earliest date of disease, progression or death due to any cause Evaluation of the efficacy of the treatment by assessment of progression-free survival. 3.5 years
Secondary Interval between the date of first T cell infusion and date of death due to any cause. Evaluation of the efficacy of the treatment by assessment of overall survival. 3.5 years
Secondary Number and % of subjects having any Long Term Follow Up Adverse Events (AEs) 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
15 years post last treatment (infusion)
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