Phase I Study of Autologous T Lymphocytes Expressing GD2-specific Chimeric Antigen and Constitutively Active IL-7 Receptors for the Treatment of Patients With Relapsed or Refractory Neuroblastoma and Other GD2 Positive Solid Cancers(GAIL-N)
The GAIL-N trial, sponsored by Baylor College of Medicine, focuses on a novel gene therapy approach using autologous T lymphocytes engineered to express GD2-specific CAR and IL-7 receptors for treating relapsed or refractory neuroblastoma and other GD2-positive solid tumors. Given the lack of standard treatment options for these patient populations, the potential market for GD2-targeted therapies is significant. The competitive landscape includes existing CAR T-cell therapies and emerging immunotherapies targeting similar pathways. Successful outcomes could position this therapy as a leading option in a niche but critical segment of oncology, particularly for pediatric cancers. Diligence should focus on the trial's safety profile, efficacy data, and potential for regulatory approval, as well as the scalability of T-cell manufacturing processes.
Indication: Relapsed Neuroblastoma
Modality: gene therapy
Target: GD2-specific Chimeric Antigen Receptor (CAR) and Constitutively Active IL-7 Receptors
Sponsor: Baylor College of Medicine
Source URL: ClinicalTrials.gov
Source updated: Detailed source ingestion pending
Ingested: Jul 02, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by target_normalized: GD2-specific Chimeric Antigen Receptor (CAR) and Constitutively Active IL-7 Receptors
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Condition raw: Relapsed Neuroblastoma, Refractory Neuroblastoma, Relapsed Osteosarcoma, Relapsed Ewing Sarcoma, Relapsed Rhabdomyosarcoma, Uveal Melanoma, Phyllodes Breast Tumor
Condition normalized: Relapsed Neuroblastoma, Refractory Neuroblastoma, Relapsed Osteosarcoma, Relapsed Ewing Sarcoma, Relapsed Rhabdomyosarcoma, Uveal Melanoma, Phyllodes Breast Tumor
Modality raw: gene therapy
Modality normalized: gene therapy
Target raw: GD2-specific Chimeric Antigen Receptor (CAR) and Constitutively Active IL-7 Receptors
Target normalized: GD2-specific Chimeric Antigen Receptor (CAR) and Constitutively Active IL-7 Receptors