NCT03132922 · REGISTRY CONDITION SEARCH

MAGE-A4ᶜ¹º³²T for Multi-Tumor

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1
Status at capture: ACTIVE NOT RECRUITING
Registry last update: 2026-06-04

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Adverse Events (AE) Including Serious Adverse Events (SAE)

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outcome · POSTED

Peak Persistence

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outcome · POSTED

Replication Competent Lentivirus (RCL)

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outcome · POSTED

Overall Response Rate (ORR)

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outcome · POSTED

Best Overall Response (BOR)

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outcome · POSTED

Time to Response (TTR)

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outcome · POSTED

Duration of Response (DoR)

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outcome · POSTED

Duration of Stable Disease (DoSD)

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outcome · POSTED

Progression Free Survival (PFS)

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outcome · POSTED

Overall Survival (OS)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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.
healthy Volunteers: false
maximum Age: 75 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

intervention Names
Genetic: Autologous genetically modified MAGE-A4ᶜ¹º³²T cells
label
Autologous genetically modified MAGE-A4ᶜ¹º³²T cells
type
EXPERIMENTAL
intervention Names
Radiation: Autologous genetically modified MAGE-A4c1032T cells combined with low dose radiation
label
Radiation Sub-Study: Autologous genetically modified MAGE-A4c1
type
EXPERIMENTAL

interventions

arm Group Labels
Autologous genetically modified MAGE-A4ᶜ¹º³²T cells
description
Infusion of autologous genetically modified MAGE-A4ᶜ¹º³²T on Day 1
name
Autologous genetically modified MAGE-A4ᶜ¹º³²T cells
type
GENETIC
arm Group Labels
Radiation Sub-Study: Autologous genetically modified MAGE-A4c1
description
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
name
Autologous genetically modified MAGE-A4c1032T cells combined with low dose radiation
type
RADIATION

Study design

allocation

NON_RANDOMIZED

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 71
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Adverse Events (AE) Including Serious Adverse Events (SAE)
time Frame
From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years).
description
Peak persistence of afamitresgene autoleucel cells was reported as vector copy numbers per microgram of genomic DNA from peripheral blood mononuclear cell (PBMC).
measure
Peak Persistence
time Frame
From afamitresgene autoleucel infusion up to 18 months post-infusion
description
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.
measure
Replication Competent Lentivirus (RCL)
time Frame
From afamitresgene autoleucel infusion to 3 months post-infusion

secondary Outcomes

description
ORR, defined as the proportion of participants with Best Overall Response (BOR) of confirmed completed response (CR) or partial response (PR) among participants with measurable disease at Baseline. The ORR was based on the assessment of response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by local radiologist. Participants with unknown or missing response were treated as non-responders.
measure
Overall Response Rate (ORR)
time Frame
From afamitresgene autoleucel infusion until disease progression/recurrence (up to 3.2 years)
description
BOR was defined as the best response recorded from the date of T-cell infusion until disease progression. Response categories from best to worst were, confirmed CR, confirmed PR, stable disease (SD), progressive disease (PD), and not evaluable (NE) (per RECIST v1.1)
measure
Best Overall Response (BOR)
time Frame
From afamitresgene autoleucel infusion until disease progression/recurrence (up to 3.2 years)
description
TTR was defined as the interval between the date of the first T-cell infusion and the earliest date of the first documented confirmed CR or confirmed PR.
measure
Time to Response (TTR)
time Frame
From afamitresgene autoleucel infusion until first documented confirmed CR or PR
description
DoR was measured from the first CR/PR (whichever was first recorded) until the first date of progressive disease.
measure
Duration of Response (DoR)
time Frame
From initial confirmed response (DR or PR) until PD or censored date. is defined as all participants who had not experienced the event of interest (i.e. ongoing, event free) at the time of the data cut off (used for the analysis).
description
DoSD was defined as the time from the date of T-cell infusion to the first date of the radiological PD. This analysis of DoSD only applied to participants with BOR as confirmed CR, confirmed PR, or confirmed SD.
measure
Duration of Stable Disease (DoSD)
time Frame
From date of afamitresgene autoleucel infusion to first date of radiological PD or censored date
description
PFS was defined as the time from the date of the first T-cell infusion to the first date of the radiological PD or death date (due to any reason), whichever event was earlier.
measure
Progression Free Survival (PFS)
time Frame
From afamitresgene autoleucel infusion until first documented PD or death due to any cause, whichever comes first, or censored date.
description
OS was defined as the time from the date of afamitresgene autoleucel infusion to the date of death (due to any reason).
measure
Overall Survival (OS)
time Frame
From afamitresgene autoleucel infusion until death due to any reason or censored date From afamitresgene autoleucel infusion until death due to any reason or censored date

Full study description

brief 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.

Source references

references

citation
Hong DS, Van Tine BA, Biswas S, McAlpine C, Johnson ML, Olszanski AJ, Clarke JM, Araujo D, Blumenschein GR Jr, Kebriaei P, Lin Q, Tipping AJ, Sanderson JP, Wang R, Trivedi T, Annareddy T, Bai J, Rafail S, Sun A, Fernandes L, Navenot JM, Bushman FD, Everett JK, Karadeniz D, Broad R, Isabelle M, Naidoo R, Bath N, Betts G, Wolchinsky Z, Batrakou DG, Van Winkle E, Elefant E, Ghobadi A, Cashen A, Grand'Maison A, McCarthy P, Fracasso PM, Norry E, Williams D, Druta M, Liebner DA, Odunsi K, Butler MO. Autologous T cell therapy for MAGE-A4+ solid cancers in HLA-A*02+ patients: a phase 1 trial. Nat Med. 2023 Jan;29(1):104-114. doi: 10.1038/s41591-022-02128-z. Epub 2023 Jan 9.
pmid
36624315
type
DERIVED
citation
Sanderson JP, Crowley DJ, Wiedermann GE, Quinn LL, Crossland KL, Tunbridge HM, Cornforth TV, Barnes CS, Ahmed T, Howe K, Saini M, Abbott RJ, Anderson VE, Tavano B, Maroto M, Gerry AB. Preclinical evaluation of an affinity-enhanced MAGE-A4-specific T-cell receptor for adoptive T-cell therapy. Oncoimmunology. 2019 Nov 24;9(1):1682381. doi: 10.1080/2162402X.2019.1682381. eCollection 2020.
pmid
32002290
type
DERIVED

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice