Clinical trial · Interventional
Using Gene Modified Neuroblastoma Cells for the Treatment of Relapsed/Refractory Neuroblastoma
Phase I Study of Chemokine and Cytokine Gene Modified Autologous Neuroblastoma Cells for Treatment of Relapsed/Refractory Neuroblastoma Using an Adenoviral Vector (CYCHE)
- 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)
This research study is designed to determine the safety and dosage of special cells that may make a patients own immune system fight the cancer. To do this we will put two special genes into cancer cells taken from the patients body. The genes we put in make the cancer cells produce lymphotactin, a natural substance that attracts immune system cells to the cancer, and IL-2 a natural substance that may help the immune system kill cancer cells. Some of these cells will then be put back in the patient's body. Studies of cancers in animals and in cancer cells that are grown in laboratories suggest that substances like lymphotactin and IL-2 help the body kill cancer cells. A treatment similar to this has been used in ten children previously and similar treatments are being used in adults with other cancers. The purpose of this study is to learn the side effects and safe 'dosage' of these special cells.
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 |
|---|---|---|---|
| Gene Modified Neuroblastoma Cells | Genetic | — | UNRESOLVED |
| Skin Biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gene Modified Neuroblastoma Cells
- description
- Gene modified neuroblastoma cells given as 4 subcutaneous injections over 5 weeks
- interventionNames
- Procedure: Skin Biopsy
- Genetic: Gene Modified Neuroblastoma Cells
Primary outcomes (2)
- measure
- To determine the safety of up to four subcutaneous (SC) injections of autologous neuroblastoma cells which have been genetically modified by adenoviral vectors to secrete lymphotactin (Lptn) and Interleukin-2 (IL-2).
- timeFrame
- 2 months
- measure
- To determine the safety of up to eight (total) of these injections in patients who have received the first four injections without unacceptable toxicity and have evidence of stable disease or better after receiving these injections.
- timeFrame
- 6 months
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
* All patients under 21 years of age at diagnosis with recurrent, advanced stage neuroblastoma. * Patients must have a life expectancy of at least 8 weeks. * Patients must have recovered from the toxic effects of all prior chemotherapy before entering this study, and have an absolute lymphocyte and neutrophil count of \>500/mm3 each. * Patients must not be currently receiving any investigational agents or have not received any tumor vaccines within the previous six weeks. * Patients must not be HIV-positive. * Patients must have bilirubin \<1.5 mg%. * Patients must have creatinine \<1.5 mg/dl. * Patients must have ECOG performance status of 0-2. * Patients must have autologous transduced neuroblastoma cells available that are demonstrably producing \>150 pg IL-2/106 cells/24 hr and are secreting Lptn. * Patients or legal guardians must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects. Patients or their guardians will be given a copy of the consent form. * Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 3 months after the study is concluded. The male partner should use a condom.
References
Publications (0)
Data not yet available