RECRUITING

SPEARHEAD-3 Pediatric Study

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 2-17 years of age with advanced cancers.

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

Quick Facts

Study Start:2023-09-01

Study Completion:2038-07-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05642455

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.

Ages Eligible for Study:2 Years to 21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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: * 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:	* 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.

Inclusion Criteria

Exclusion 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:
* 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:

* 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.

Contacts and Locations

Principal Investigator

Fiorella Iglesias Cardenas, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Kids

Study Locations (Sites)

Stanford University

Palo Alto, California, 94305

United States

National Institutes of Health

Bethesda, Maryland, 20892

United States

Dana Farber Cancer Institute

Boston, Massachusetts, 10065

United States

Washington University

Saint Louis, Missouri, 63110

United States

Memorial Sloan Kettering Kids

New York, New York, 10065

United States

Duke University School of Medicine

Durham, North Carolina, 27710

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

United States

Children's Hospital of Philedephia

Philadelphia, Pennsylvania, 19104

United States

Seattle Children's Hospital

Seattle, Washington, 98105

United States

University of Wisconsin Cancer Center

Madison, Wisconsin, 53715

United States

Collaborators and Investigators

Sponsor: Adaptimmune

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-01

Study Completion Date2038-07-30

Study Record Updates

Study Start Date2023-09-01

Study Completion Date2038-07-30

Terms related to this study

Additional Relevant MeSH Terms

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