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Synovial SarcomaPhase 1/2NCT05642455

SPEARHEAD-3 Pediatric Study

A Phase 1/2 study testing Afamitresgene autoleucel in people with Synovial Sarcoma and Malignant Peripheral Nerve Sheath Tumor (MPNST), run by USWM CT, LLC at 10 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a pediatric basket study to investigate the safety and efficacy of afamitresgene autoleucel in HLA-A*02 eligible and MAGE-A4 positive subjects aged 2-17 years of age with advanced cancers. Read more about this study

Who is it for?
Ages 2 to 21 years
What is being tested?
Afamitresgene autoleucel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
10 sitesUnited States
Study dates
1 Sep 2023to 30 Jul 2038
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Subject has histologically confirmed diagnosis of any one of the following cancers: (A) Synovial Sarcoma (SS), (B) MPNST, (C) Neuroblastoma, or (D) Osteosarcoma (OS).
  • Age:
  • Synovial Sarcoma: 2 to 17 years (B) MPNST, Neuroblastoma and Osteosarcoma: 2 to 21 years
  • Body weight ≥ 10 kg
  • Must have previously received a systemic chemotherapy
  • Measurable disease prior to lymphodepletion according to RECIST v1.1 (or INCR, 2017 Neuroblastoma only).
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  • HLA-A*02 positive
  • Tumor shows MAGE-A4 expression confirmed by central laboratory.
  • Performance Status:
  • Subjects ≥16: Eastern Cooperative Oncology Group (ECOG) 0 or 1 (B) Subjects 2 to 16: Lansky score ≥ 80
  • Subject has anticipated life expectancy of greater than 3 months in the opinion of the investigator.

Who cannot join

  • Positive for HLA-A*02:05 in either allele; or any A*02 having same protein sequence as HLA-A*02:05
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide.
  • History of autoimmune or immune mediated disease
  • Known central nervous system (CNS) metastases.
  • Other prior malignancy that is not considered by the Investigator to be in complete remission
  • Clinically significant cardiovascular disease
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  • Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or human T cell leukemia virus
  • Pregnant or breastfeeding
  • Experiencing ongoing rapid disease progression that in the opinion of the Investigator significantly increases the subjects risk associated with treatment.

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

10 sites in 1 country

United States10 sites, 10 recruiting

  • National Institutes of Health

    Bethesda, Maryland, 20892

    Jessica Lake, 240-858-7789, Jessica.lake@nih.gov

    John Glod, MD

    Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 10065

    Alyssa Giammanco, 617-632-3027, dfbchpedicelltherapy@dfci.harvard.edu

    Natalie Collins, MD

    Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

    Brian Turpin, DO, 513-636-2799, cancer@cchmc.org

    Brian Turpin, DO

    Recruiting

  • Duke University School of Medicine

    Durham, North Carolina, 27710

    Kris Mahadeo, MD, 919-668-1180, kris.mahadeo@duke.edu

    Kris Mahadeo, MD

    Recruiting

  • University of Wisconsin Cancer Center

    Madison, Wisconsin, 53715

    Jenny Weiland, BS, 608-890-8070, pedshemoncresearch@g-groups.wisc.edu

    Christian Capitini, MD

    Recruiting

  • Memorial Sloan Kettering Kids

    New York, New York, 10065

    Fiorella Iglesias Cardenas, MD, 212-639-6649, iglesiaf@mskcc.org

    Fiorella Iglesias Cardenas, MD

    Recruiting

  • Stanford University

    Palo Alto, California, 94305

    Amy Li, 650-788-6811, ali4@stanford.edu

    Sneha Ramakrishna, MD

    Recruiting

  • Children's Hospital of Philedephia

    Philadelphia, Pennsylvania, 19104

    Shelby Brizzolara-Dove, BS, 267-425-5544, CancerTrials@chop.edu

    Theodore Laetsch, MD

    Recruiting

  • Seattle Children's Hospital

    Seattle, Washington, 98105

    CBDC Intake, 206-987-2106, cbdcintake@seattlechildrens.org

    Mark Fluchel, MD

    Recruiting

  • Washington University

    St Louis, Missouri, 63110

    Tina Primeau, BA, 314-454-2147, tprimeau@wustl.edu

    Catie Knoerle, BA, 314-747-1828, knoerlec@wustl.edu

    Recruiting

Other trials in United States

About this study

Official title: A Phase 1/2 Open Label, Basket Study to Assess the Safety, Tolerability and Anti-Tumor Activity of Afamitresgene Autoleucel in Pediatric Subjects With MAGE-A4 Positive Tumors

This is a pediatric basket study to investigate the safety and efficacy of afamitresgene autoleucel in HLA-A*02 eligible and MAGE-A4 positive subjects aged 2-17 years of age with advanced cancers.

Being tested
Afamitresgene autoleucel
Medical subject headings
Sarcoma, Synovial, Neurofibrosarcoma, Neuroblastoma, Osteosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Afamitresgene autoleucelGenetic

    Single infusion of afamitresgene autoleucel Dose: For subjects ≥10 kg to <40 kg: starting dose of 0.025 - 0.200 x 10'9 transduced cells/kg. For subjects ≥40 kg 1.0x109 to 10x109 transduced by a single intravenous infusion

Study groups in NCT05642455
Study groupRoleWhat they receive
Afamitresgene autoleucelExperimentalNot described
Receives: Genetic: Afamitresgene autoleucel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence, duration, and severity of Treatment Emergent Adverse Events as assessed by Investigator Evaluation.

    Determination of incidence, severity and duration of adverse events

    • Incidence of dose limiting toxicities DLTs
    • AEs including serious adverse events (SAEs)
    • Incidence, severity, and duration of the AEs of special interest
    • Replication competent lentivirus (RCL)
    • T-cell clonality and insertional oncogenesis (IO)

    Measured: 3.5 years

Secondary outcomes (8)

  1. Efficacy: Objective response rate (ORR) assessed by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (or by International Neuroblastoma Response Criteria [INRC] 2017 in Neuroblastoma subjects)

    ORR is defined as incidence of complete responses or partial responses as assessed by RECIST v1.1 or INRC, 2017

    Measured: 3.5 years

  2. Time to response (TTR)

    For patients who are observed to respond to afamitresgene autoleucel in the time from date of infusion to achieve a partial response or complete response (TTR) is assessed

    Measured: 3.5 years

  3. Duration of Response (DoR)

    For patients who are observed to respond to afamitresgene autoleucel the DoR is the date of initial response (including confirmation) from date of infusion up until disease progression

    Measured: 3.5 years

  4. Best overall response (BOR)

    BOR is assessed by the investigator per RECIST V1.1 or INCR, 2017 (for Neuroblastoma subjects)

    Measured: 3.5 years

  5. Progression Free Survival (PFS)

    PFS is assessed by the investigator from date of infusion of ADP-A2M4 up until the date of disease progression per RECIST v1.1 or death.

    Measured: 3.5 years

  6. Overall Survival (OS)

    OS is assessed from date of infusion of ADP-A2M4 up until the date of patient death.

    Measured: 15 years

  7. Characterize the in vivo cellular pharmacokinetics (PK) profile of afamitresgene autoleucel by evaluation of PBMC samples for peak persistence.

    Obtain PBMC samples for the evaluation of peak persistence of afamitresgene autoleucel.

    Measured: 3.5 years

  8. Development and validation of an invitro diagnostic (IVD) assay for the screening of tumor antigen expression for regulatory approval.

    Retention of additional tumor tissue during Pre-Screening to enable development and validation of a MAGE-A4 antigen expression companion diagnostic (CDx) assay.

    Measured: 3.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2022
  2. Study start1 Sep 2023
  3. Primary completion1 Oct 2026 (estimated)
  4. Study completion30 Jul 2038 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05642455
Sponsor's protocol ID
ADP-0044-004
Status last verified
Feb 2026
First submitted
7 Nov 2022
Last updated
11 Aug 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Afamitresgene autoleucel in people with Synovial Sarcoma and Malignant Peripheral Nerve Sheath Tumor (MPNST), run by USWM CT, LLC at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence, duration, and severity of Treatment Emergent Adverse Events as assessed by Investigator Evaluation. (time frame: 3.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05642455.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.

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SPEARHEAD-3 Pediatric Study (NCT05642455) | AzTrials