SPEARHEAD-3 Pediatric Study

Part of paid clinical trials in Palo Alto, California.

Sponsor
USWM CT, LLC
Study ID
NCT05642455
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Malignant Peripheral Nerve Sheath Tumor (MPNST)
  • Neuroblastoma (NBL)
  • Osteosarcoma
  • Synovial Sarcoma

Eligibility Criteria

Sex
ALL
Age
2 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Afamitresgene autoleucel — GENETIC
    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 Details

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.

Key Dates

Start date
Sep 1, 2023
Status verified
Feb 2026
Primary completion
Oct 1, 2026
Completion
Jul 30, 2038

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Afamitresgene autoleucel

Primary Outcome Measure

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

Locations (10)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94305
Amy Li
[email protected]
650-788-6811
Sneha Ramakrishna, MD (PRINCIPAL_INVESTIGATOR)
National Institutes of HealthBethesdaMaryland20892
Kane Kaosaard
[email protected]
301-204-9057
John Glod, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts10065
Natalie Collins, MD (PRINCIPAL_INVESTIGATOR)
Washington UniversitySt LouisMissouri63110
Tina Primeau, BA
[email protected]
314-454-2147
Catie Knoerle, BA
[email protected]
314-747-1828
Amy Armstrong, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering KidsNew YorkNew York10065
Fiorella Iglesias Cardenas, MD
[email protected]
212-639-6649
Fiorella Iglesias Cardenas, MD (PRINCIPAL_INVESTIGATOR)
Duke University School of MedicineDurhamNorth Carolina27710
Kris Mahadeo, MD
[email protected]
919-668-1180
Kris Mahadeo, MD (PRINCIPAL_INVESTIGATOR)
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Brian Turpin, DO
[email protected]
513-636-2799
Brian Turpin, DO (PRINCIPAL_INVESTIGATOR)
Children's Hospital of PhiledephiaPhiladelphiaPennsylvania19104
Shelby Brizzolara-Dove, BS
[email protected]
267-425-5544
Theodore Laetsch, MD (PRINCIPAL_INVESTIGATOR)
Seattle Children's HospitalSeattleWashington98105
Mark Fluchel, MD (PRINCIPAL_INVESTIGATOR)
University of Wisconsin Cancer CenterMadisonWisconsin53715
Jenny Weiland, BS
[email protected]
608-890-8070
Christian Capitini, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Stanford University· Palo Alto, CANational Institutes of Health· Bethesda, MDDana Farber Cancer Institute· Boston, MAWashington University· St Louis, MOMemorial Sloan Kettering Kids· New York, NYDuke University School of Medicine· Durham, NC

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