Autologous genetically modified MAGE-A4ᶜ¹º³²T cells: Infusion of autologous genetically modified MAGE-A4ᶜ¹º³²T on Day 1
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
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Adverse Events (AE) Including Serious Adverse Events (SAE) — From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years). An AE was defined as any untoward medical occurrence in a clinical study participant who received a pharmaceutical product, regardless of causality. An AE was , therefore, any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with AEs (including SAEs) are presented.
Peak Persistence — From afamitresgene autoleucel infusion up to 18 months post-infusion Peak persistence of afamitresgene autoleucel cells was reported as vector copy numbers per microgram of genomic DNA from peripheral blood mononuclear cell (PBMC).
Replication Competent Lentivirus (RCL) — From afamitresgene autoleucel infusion to 3 months post-infusion The presence of RCL was assessed by quantitative polymerase chain reaction (qPCR) targeting a segment of the vesicular stomatitis virus glycoprotein (VSV-G) coding sequence.
Trial sites (11)
Facility
City
Region
Status
University of Miami
Miami
Florida
Moffitt Cancer Center
Tampa
Florida
Washington University School of Medicine
St Louis
Missouri
Washington University
St Louis
Missouri
Roswell Park Cancer Institute
Buffalo
New York
Duke University Medical Center, Duke Cancer Institute
Durham
North Carolina
Ohio State University Wexner Medical Center
Columbus
Ohio
Fox Chase Cancer Center
Philadelphia
Pennsylvania
Tennessee Oncology - Sarah Cannon Research Institute
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.