SPEARHEAD-3 Pediatric Study

Adaptimmune

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Osteosarcoma

Neuroblastoma (NBL)

Malignant Peripheral Nerve Sheath Tumor (MPNST)

Synovial Sarcoma

Treatments

Genetic: Afamitresgene autoleucel

Study type

Interventional

Funder types

Industry

Identifiers

NCT05642455

ADP-0044-004

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

2 to 21 years old

Volunteers

No Healthy Volunteers

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.