NCT05642455 SPEARHEAD-3 Pediatric Study
| NCT ID | NCT05642455 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | USWM CT, LLC |
| Condition | Synovial Sarcoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2023-09-01 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Fiorella Iglesias Cardenas, MD
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Kids
Frequently Asked Questions
Who can join the NCT05642455 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 21 Years, studying Synovial Sarcoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05642455 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05642455 currently recruiting?
Yes, NCT05642455 is actively recruiting participants. Visit ClinicalTrials.gov or contact USWM CT, LLC to inquire about joining.
Where is the NCT05642455 trial being conducted?
This trial is being conducted at Palo Alto, United States, Bethesda, United States, Boston, United States, St Louis, United States and 6 additional locations.
Who is sponsoring the NCT05642455 clinical trial?
NCT05642455 is sponsored by USWM CT, LLC. The principal investigator is Fiorella Iglesias Cardenas, MD at Memorial Sloan Kettering Kids. The trial plans to enroll 20 participants.