SPEARHEAD-3 Study for Children and Young Adults
Sponsor: Adaptimmune
Sponsor score: 60
ClinicalTrials ID:NCT05642455
This clinical trial is exploring the safety and effectiveness of a new treatment called afamitresgene autoleucel for children and young adults aged 2 to 21 with certain advanced cancers. The study is for those who have specific genetic markers and cancer types.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The SPEARHEAD-3 study is designed to test a new treatment, afamitresgene autoleucel, in children and young adults aged 2 to 21 who have advanced cancers. The study focuses on patients who have specific genetic markers, including HLA-A*02 and MAGE-A4, and aims to determine if the treatment is safe and effective for these patients.
Eligibility Criteria
Inclusion Criteria
- Aged between 2 and 21 years old.
- Weigh at least 10 kg (about 22 pounds).
- Diagnosed with one of the following cancers: Synovial Sarcoma, MPNST, Neuroblastoma, or Osteosarcoma.
- Have received chemotherapy treatment before.
- Have a tumor that can be measured by standard medical criteria.
- Test positive for the HLA-A*02 genetic marker.
- Tumor shows MAGE-A4 expression, confirmed by a central lab.
- Have a good performance status, meaning they are active and able to carry out daily activities.
Exclusion Criteria
- Have the HLA-A*02:05 genetic marker or similar.
- Have had allergic reactions to similar drugs like fludarabine or cyclophosphamide.
- Have a history of autoimmune or immune-related diseases.
- Have cancer that has spread to the brain or spinal cord.
- Have another type of cancer that is not in complete remission.
- Have significant heart disease.
- Have active infections like HIV, hepatitis B, hepatitis C, or human T cell leukemia virus.
- Are pregnant or breastfeeding.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Stanford University | 94305 | Palo Alto | California |
| University of Colorado | 80045, | Aurora | Colorado |
| National Institutes of Health | 20892 | Bethesda | Maryland |
| Dana Farber Cancer Institute | 10065 | Boston | Massachusetts |
| Washington University | 63110 | Saint Louis | Missouri |
| Memorial Sloan Kettering Kids | 10065 | New York | New York |
| Duke University School of Medicine | 27710 | Durham | North Carolina |
| Cincinnati Children's Hospital Medical Center | 45229 | Cincinnati | Ohio |
| Children's Hospital of Philedephia | 19104 | Philadelphia | Pennsylvania |
| Seattle Children's Hospital | 98105 | Seattle | Washington |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.