Recruiting

Phase 1

Phase 2

SPEARHEAD-3SPEARHEAD-3 Pediatric Study

Sponsor:

USWM CT, LLC

Code:

NCT05642455

Conditions

Synovial Sarcoma

Malignant Peripheral Nerve Sheath Tumor (MPNST)

Neuroblastoma (NBL)

Osteosarcoma

Eligibility Criteria

Sex: All

Age: 2 - 21

Healthy Volunteers: Not accepted

Interventions

Afamitresgene autoleucel

Study Details

Brief 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.

Conditions

Synovial Sarcoma

Malignant Peripheral Nerve Sheath Tumor (MPNST)

Neuroblastoma (NBL)

Osteosarcoma

Study ID

NCT05642455

Start date

Sep 1, 2023

Status verified date

Feb, 2026

Completion date

Jul 30, 2038

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 2 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria:

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:

(A) 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).
HLA-A\*02 positive
Tumor shows MAGE-A4 expression confirmed by central laboratory.
Performance Status:

(A) 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.

Exclusion Criteria:

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
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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Afamitresgene autoleucel

Interventions

Afamitresgene autoleucel

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

Primary outcome measure

Incidence, duration, and severity of Treatment Emergent Adverse Events as assessed by Investigator Evaluation. [ Time Frame: 3.5 years ]

Central Contacts and Locations

Locations

Stanford University

Recruiting

Palo Alto, California, United States, 94305

Contacts

Amy Li

650-788-6811 ali4@stanford.edu

Principal Investigator:

Sneha Ramakrishna, MD

National Institutes of Health

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

Jessica Lake

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

Principal Investigator:

John Glod, MD

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 10065

Contacts

Alyssa Giammanco

617-632-3027 dfbchpedicelltherapy@dfci.harvard.edu

Principal Investigator:

Natalie Collins, MD

Washington University

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Tina Primeau, BA

314-454-2147 tprimeau@wustl.edu

Catie Knoerle, BA

314-747-1828 knoerlec@wustl.edu

Principal Investigator:

Amy Armstrong, MD

Memorial Sloan Kettering Kids

Recruiting

New York, New York, United States, 10065

Contacts

Fiorella Iglesias Cardenas, MD

212-639-6649 iglesiaf@mskcc.org

Principal Investigator:

Fiorella Iglesias Cardenas, MD

Duke University School of Medicine

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Kris Mahadeo, MD

919-668-1180 kris.mahadeo@duke.edu

Principal Investigator:

Kris Mahadeo, MD

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Brian Turpin, DO

513-636-2799 cancer@cchmc.org

Principal Investigator:

Brian Turpin, DO

Children's Hospital of Philedephia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Shelby Brizzolara-Dove, BS

267-425-5544 CancerTrials@chop.edu

Principal Investigator:

Theodore Laetsch, MD

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

CBDC Intake

206-987-2106 cbdcintake@seattlechildrens.org

Principal Investigator:

Mark Fluchel, MD

University of Wisconsin Cancer Center

Recruiting

Madison, Wisconsin, United States, 53715

Contacts

Jenny Weiland, BS

608-890-8070 pedshemoncresearch@g-groups.wisc.edu

Principal Investigator:

Christian Capitini, MD

More Information

Sponsor

USWM CT, LLC

Last update posted

Aug 11, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by USWM CT, LLC on 2026-08-11.