Ovarian Cancer Clinical Trial
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
Verified date | January 2024 |
Source | Adaptimmune |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Adaptimmune |
United States, Canada,
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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