Clinical trial · Interventional
A Phase I/II Study Of Immunization With Lymphotactin And Interleukin 2 Gene Modified Neuroblastoma Tumor Cells
A Phase I/II Study Of Immunization With Lymphotactin And Interleukin 2 Gene Modified Neuroblastoma Tumor Cells After High-Dose Chemotherapy And Autologous Stem Cell Rescue In Patients With High Risk Neuroblastoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators intend to test the safety, and immunologic and clinical efficacy of a combination of 2 allogeneic neuroblastoma tumor cell line vaccines, one of which has been genetically modified to secrete the cytokine/chemokine combination of IL-2 and lymphotactin, in patients undergoing chemotherapy for newly diagnosed, high risk neuroblastoma who receive single autologous stem cell rescue as consolidation therapy. This protocol will be carried out as a Phase I/IIa study to evaluate the safety and toxicity of adding a previously unstudied, unmodified, irradiated neuroblastoma cell line (SKNLP) to a studied, safe dose of a gene modified, IL-2/Lptn secreting neuroblastoma cell line SJNB-JF-IL2/Lptn to be given as a vaccine to patients diagnosed with high risk neuroblastoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SNJB-JF-IL2 and SJNB-JF-Lptn + Dose Level 1 SKNLP | Biological | — | UNRESOLVED |
| SNJB-JF-IL2 and SJNB-JF-Lptn + Dose Level 2 SKNLP | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose Level 1
- description
- SNJB-JF-IL2 and SJNB-JF-Lptn + Dose Level 1 SKNLP
- interventionNames
- Biological: SNJB-JF-IL2 and SJNB-JF-Lptn + Dose Level 1 SKNLP
- type
- EXPERIMENTAL
- label
- Dose Level 2
- description
- SNJB-JF-IL2 and SJNB-JF-Lptn + Dose Level 2 SKNLP
- interventionNames
- Biological: SNJB-JF-IL2 and SJNB-JF-Lptn + Dose Level 2 SKNLP
Primary outcomes (1)
- measure
- Evaluate the safety of repeated immunization with gene-modified, IL-2/lymphotactin secreting SJNB-JF-IL2 and SJNB-JF-Lptn cells co-administered with the unmodified SKNLP neuroblastoma cell line.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: Age \<21 years at time of diagnosis Histological proof of high-risk neuroblastoma at diagnosis Anticipating single autologous stem cell rescue following high dose consolidation chemotherapy Meet all eligibility criteria for high dose chemotherapy with stem cell rescue per institutional standard Signed informed consent Patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom. HIV negative Exclusion Criteria: Patients must not be currently receiving any investigational agents or have received any tumor vaccines within the previous six months Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Pregnant HIV-positive patients regardless of treatment status
References
Publications (0)
Data not yet available