SPEARHEAD-3 Study for Children and Young Adults

Sponsor: Adaptimmune

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05642455

Provider View

This clinical trial is exploring the safety and effectiveness of a new treatment called afamitresgene autoleucel for children and young adults aged 2 to 21 with certain advanced cancers. The study is for those who have specific genetic markers and cancer types.

Patient Parameters

Program Overview

The SPEARHEAD-3 study is designed to test a new treatment, afamitresgene autoleucel, in children and young adults aged 2 to 21 who have advanced cancers. The study focuses on patients who have specific genetic markers, including HLA-A*02 and MAGE-A4, and aims to determine if the treatment is safe and effective for these patients.

Eligibility Criteria

Inclusion Criteria

  • Aged between 2 and 21 years old.
  • Weigh at least 10 kg (about 22 pounds).
  • Diagnosed with one of the following cancers: Synovial Sarcoma, MPNST, Neuroblastoma, or Osteosarcoma.
  • Have received chemotherapy treatment before.
  • Have a tumor that can be measured by standard medical criteria.
  • Test positive for the HLA-A*02 genetic marker.
  • Tumor shows MAGE-A4 expression, confirmed by a central lab.
  • Have a good performance status, meaning they are active and able to carry out daily activities.

Exclusion Criteria

  • Have the HLA-A*02:05 genetic marker or similar.
  • Have had allergic reactions to similar drugs like fludarabine or cyclophosphamide.
  • Have a history of autoimmune or immune-related diseases.
  • Have cancer that has spread to the brain or spinal cord.
  • Have another type of cancer that is not in complete remission.
  • Have significant heart disease.
  • Have active infections like HIV, hepatitis B, hepatitis C, or human T cell leukemia virus.
  • Are pregnant or breastfeeding.

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