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Clinical Trials in the USA / NCT03132922
Active, not recruiting Phase 1

MAGE-A4ᶜ¹º³²T for Multi-Tumor

NCT03132922 · tracked via the Priya Life Science USA tracker
Sponsor
USWM CT, LLC
Phase
Phase 1
Started
2017-05-15
Last updated
2026-06-04

Condition(s) studied

Urinary Bladder CancerMelanomaHead and Neck CancerOvarian CancerNon-Small Cell Lung CancerEsophageal CancerGastric CancerSynovial SarcomaMyxoid Round Cell LiposarcomaGastroesophageal Junction

Investigational drug(s) / intervention(s)

Autologous genetically modified MAGE-A4ᶜ¹º³²T cellsAutologous genetically modified MAGE-A4c1032T cells combined with low dose radiation

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)

FacilityCityRegionStatus
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 Nashville Tennessee
M.D. Anderson Cancer Center Houston Texas
Princess Margaret Cancer Centre Toronto Ontario

More USWM CT, LLC trials in the USA

SPEARHEAD-3 Pediatric Study Recruiting
Adoptive Cell Therapy Long-term Follow-up (LTFU) Study Enrolling by invitation
Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma Active, not recruiting
Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Solid Tumors Active, not recruiting
ADP-A2M4CD8 as Monotherapy or in Combination With Either Nivolumab or Pembrolizumab in HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS) Active, not recruiting

Other trials for the same condition

Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors Recruiting
A Study of Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for Adult Patients With Operable Non-Small Cell Lung Cancer (NSCLC) Active, not recruiting
SPEARHEAD-3 Pediatric Study Recruiting
Evorpacept (ALX148) in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04) Active, not recruiting
Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy for EGFRmt Non-small Cell Lung Cancer (IZABRIGHT-Lung02) Recruiting
Official registry record

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.

View NCT03132922 on ClinicalTrials.gov ↗ ← All trials in the USA