SPEARHEAD-3 Pediatric Study

Sponsor: Adaptimmune

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05642455

Patient View

The SPEARHEAD-3 Pediatric Study evaluates the safety and efficacy of afamitresgene autoleucel in HLA-A*02 and MAGE-A4 positive subjects aged 2-21 with advanced cancers. Eligible participants must weigh ≥10 kg, have specific cancer types, prior chemotherapy, measurable disease, and good performance status. The intervention involves a single infusion of transduced cells, with dosage based on body weight.

Patient Parameters

Program Overview

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 2-21 years of age with advanced cancers

Eligibility Criteria

Inclusion Criteria

  • Age 2-21 years
  • Body weight ≥ 10 kg
  • Subject has histologically confirmed diagnosis of any one of the following cancers: (A) Synovial Sarcoma, (B) MPNST, (C) Neuroblastoma, or (D) Osteosarcoma
  • Must have previously received a systemic chemotherapy
  • Measurable disease 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: ECOG 0-1 or Lansky Score ≥ 80

Exclusion Criteria

  • 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

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