Back to search results

SPEARHEAD-3 Pediatric Study for Advanced Cancers

This study is looking at the safety and effectiveness of a treatment called afamitresgene autoleucel for children and young adults with certain advanced cancers. These cancers include Synovial Sarcoma, Malignant Peripheral Nerve Sheath Tumor (MPNST), Neuroblastoma, or Osteosarcoma. You might be able to join if you are between 2 and 21 years old (depending on your specific cancer type), weigh at least 10 kg, and have already received chemotherapy. The main goal is to see how safe the treatment is by tracking any side effects over 3.5 years. This study is currently unclear on its recruitment status and plans to enroll 20 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 20 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 3.5 years to assess treatment side effects.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05642455

SPEARHEAD-3 Pediatric Study

Recruiting
PHASE1Ages 2–21InterventionalTreatment
USWM CT, LLC
~20 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:Afamitresgene autoleucel

At a glance

Recruiting sites
10 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence, duration, and severity of Treatment Emergent Adverse Events as assessed by Investigator Evaluation.
Measured over 3.5 years

Conditions

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

Explore related trials

Malignant Peripheral Nerve Sheath TumorNeuroblastomaOsteosarcomaSolid NeoplasmSynovial SarcomaHLA Class I Histocompatibility Antigen, A-2 Alpha ChainMelanoma-Associated Antigen 4

Where it's being run

10 sites across 10 states
California1
Maryland1
Massachusetts1
Missouri1
New York1
North Carolina1
Ohio1
Pennsylvania1

Study leadership

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

Who to contact

Amy Li
[email protected]
650-788-6811
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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:

Exclusion

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.

What this trial measures

  • Incidence, duration, and severity of Treatment Emergent Adverse Events as assessed by Investigator Evaluation.3.5 years

    Determination of incidence, severity and duration of adverse events * Incidence of dose limiting toxicities DLTs * AEs including serious adverse events (SAEs) * Incidence, severity, and duration of the AEs of special interest * Replication competent lentivirus (RCL) * T-cell clonality and insertional oncogenesis (IO)