Trial NCT05642455
SPEARHEAD-3 Pediatric Study
- Phase
- Phase 1/2
- Sponsor
- USWM CT, LLC
- Conditions
- Synovial Sarcoma; Malignant Peripheral Nerve Sheath Tumor (MPNST); Neuroblastoma (NBL); Osteosarcoma
- Ages
- 2–21 years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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 yearsAge
* 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 ≥ 80Performance status
• 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.Brain metastases
* Other prior malignancy that is not considered by the Investigator to be in complete remissionPrior malignancy
* Clinically significant cardiovascular diseaseCardiac
* Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or human T cell leukemia virusHIV
* Pregnant or breastfeedingPregnancy
* Experiencing ongoing rapid disease progression that in the opinion of the Investigator significantly increases the subjects risk associated with treatment.
Restrictions found (7)
- AgeOutrightinclusion
age 2 to 17 years (SS); 2 to 21 years (MPNST, neuroblastoma, osteosarcoma)
Show in the text - Brain metastasesOutrightexclusionShow in the text
- CardiacConditionalexclusionShow in the text
- HIVOutrightexclusionShow in the text
- Performance statusOutrightinclusion
ECOG 0 or 1 (≥16 years); Lansky ≥ 80 (2 to 16 years)
Show in the text - PregnancyOutrightexclusionShow in the text
- Prior malignancyConditionalexclusionShow in the text
Recruiting in Massachusetts
- Dana Farber Cancer Institute · Boston, Suffolk County