SPEARHEAD-3 Pediatric Study

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age2-21
SponsorUSWM CT, LLC

About this trial

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.

Eligibility criteria

Qualifiers

Subject has histologically confirmed diagnosis of any one of the following cancers: (A) Synovial Sarcoma (SS), (B) MPNST, (C) Neuroblastoma, or (D) Osteosarcoma (OS).

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Afamitresgene autoleucel

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators