SPEARHEAD-3 Pediatric Study

Description

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

Conditions

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

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Study Overview

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Study Details

Study 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

A Phase 1/2 Open Label, Basket Study to Assess the Safety, Tolerability and Anti-Tumor Activity of Afamitresgene Autoleucel in Pediatric Subjects With MAGE-A4 Positive Tumors

SPEARHEAD-3 Pediatric Study

Condition
Synovial Sarcoma
Intervention / Treatment

-

Contacts and Locations

Palo Alto

Stanford University, Palo Alto, California, United States, 94305

Aurora

University of Colorado, Aurora, Colorado, United States, 80045,

Bethesda

National Institue of Health, Bethesda, Maryland, United States, 80292

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 10065

Saint Louis

Washington University, Saint Louis, Missouri, United States, 63110

New York

Memorial Sloan Kettering Kids, New York, New York, United States, 10065

Durham

Duke University School of Medicine, Durham, North Carolina, United States, 27710

Cincinnati

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States, 45229

Philadelphia

Children's Hospital of Philedephia, Philadelphia, Pennsylvania, United States, 19104

Seattle

Seattle Children's Hospital, Seattle, Washington, United States, 98105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

2 Years to 21 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Adaptimmune,

Fiorella Iglesias Cardenas, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Kids

Study Record Dates

2038-07-30