OncoMatch/Clinical Trials/NCT06803875
Study of hALK.CAR T Cells for Patients With Relapsed/Refractory High-risk Neuroblastoma
Is NCT06803875 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Autologous hALK.CAR T cells for relapsed neuroblastoma.
Treatment: Autologous hALK.CAR T cells — This Phase 1/2 trial aims to determine the safety and feasibility of administration of autologous chimeric antigen receptor (CAR) T cells targeting the human Anaplastic Lymphoma Kinase (ALK) receptor in pediatric subjects with relapsed or refractory neuroblastoma (NB). The trial will be conducted in two phases: Phase 1 will determine the maximum tolerated dose (MTD) of autologous hALK.CAR T cells using a 3+3 dose escalation design. Phase 2 will be an expansion phase to determine rates of response to hALK.CAR T cells.
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroblastoma
Prior therapy
Cannot have received: CAR-T cell therapy or other gene-modified immune-effector cell therapy
Exception: eligible if >8 weeks from infusion, fully recovered from toxicities, and documented lack of persistence of the product
Patients who have received prior CART-cell or other gene-modified immune-effector cell therapy, are not eligible unless they are >8 weeks from time of infusion, have fully recovered from any associated toxicities and have documented lack of persistence of the product
Lab requirements
Blood counts
Kidney function
Liver function
Adequate organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Boston Children's Hospital · Boston, Massachusetts
- Dana-Farber Cancer Institute · Boston, Massachusetts
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