Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05642455 | RECRUITING | Synovial Sarcoma

SPEARHEAD-3 Pediatric Study
Sponsor:

Adaptimmune

Brief Summary:

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.

Condition or disease

Synovial Sarcoma

Malignant Peripheral Nerve Sheath Tumor (MPNST)

Neuroblastoma (NBL)

Osteosarcoma

Intervention/treatment

Afamitresgene autoleucel

Phase

PHASE1

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2023-09-01
Estimated Primary Completion Date : 2026-10-01
Estimated Study Completion Date : 2038-07-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 2 Years to 21 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Subject has histologically confirmed diagnosis of any one of the following cancers: (A) Synovial Sarcoma (SS), (B) MPNST, (C) Neuroblastoma, or (D) Osteosarcoma (OS).
  • * Age
    • (A) Synovial Sarcoma: 2 to 17 years (B) MPNST, Neuroblastoma and Osteosarcoma: 2 to 21 years
    • * 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).
    • * HLA-A\*02 positive
    • * Tumor shows MAGE-A4 expression confirmed by central laboratory.
    • * Performance Status
      • (A) Subjects ≥16: Eastern Cooperative Oncology Group (ECOG) 0 or 1 (B) Subjects 2 to 16: Lansky score ≥ 80
      • • Subject has anticipated life expectancy of greater than 3 months in the opinion of the investigator.
      Exclusion Criteria
      • * 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.
      • * 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
      • * Experiencing ongoing rapid disease progression that in the opinion of the Investigator significantly increases the subjects risk associated with treatment.
SPEARHEAD-3 Pediatric Study

Location Details

NCT05642455

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Stanford University

Palo Alto, California, United States, 94305

RECRUITING

United States, Maryland

National Institutes of Health

Bethesda, Maryland, United States, 20892

NOT YET RECRUITING

United States, Massachusetts

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 10065

RECRUITING

United States, Missouri

Washington University

St Louis, Missouri, United States, 63110

NOT YET RECRUITING

United States, New York

Memorial Sloan Kettering Kids

New York, New York, United States, 10065

NOT YET RECRUITING

United States, North Carolina

Duke University School of Medicine

Durham, North Carolina, United States, 27710

RECRUITING

United States, Ohio

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

RECRUITING

United States, Pennsylvania

Children's Hospital of Philedephia

Philadelphia, Pennsylvania, United States, 19104

NOT YET RECRUITING

United States, Washington

Seattle Children's Hospital

Seattle, Washington, United States, 98105

RECRUITING

United States, Wisconsin

University of Wisconsin Cancer Center

Madison, Wisconsin, United States, 53715