Clinical trial · Interventional
Study of Donor Derived, Multi-virus-specific, Cytotoxic T-Lymphocytes for Relapsed/Refractory Neuroblastoma
Phase I Study of Donor Derived,Gene Modified, Multi-virus-specific, Cytotoxic T-Lymphocytes Redirected to GD2 for Relapsed/Refractory Neuroblastoma Post-allo Stem Cell Transplantation With Submyeloblative Conditioning
- 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 is a single-center, investigator-initiated, single-arm, pilot study of post-allogeneic transplant, adoptive immunotherapy for the treatment of patients with relapsed/refractory neuroblastoma expressing the mesenchymal tumor marker GD2. Three patients will be treated. The study will focus on the safety and efficacy of allogeneic, donor derived viral specific cytotoxic T-lymphocytes, retrovirally transduced to express a chimeric antigen receptor specific for disialoganglioside, GD2, expressed on 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GD2 CAR modified Tri-virus specific cytotoxic t-cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GD2 CAR modified Tri-virus CTL infusion
- description
- A single infusion of 2x10e6 cells per meter squared was performed 30 to 120 days following allogeneic stem cell transplant.
- interventionNames
- Biological: GD2 CAR modified Tri-virus specific cytotoxic t-cells
Primary outcomes (3)
- measure
- Number of Participants With Immediate and Short Term Toxicity of Infusion Over 8 Weeks
- timeFrame
- Post infusion week 8
- description
- Immediate: Patients were monitored following infusion to assess for toxicity related to infusion. Potential toxicities related to cellular therapy infusions, such as allergic reaction to the cellular product or cryopreservation media, hemolytic reactions, volume overload, and hemodynamic instability, were monitored. Short Term: Patients were monitored for 8 weeks for short term toxicity related to infusion. Such adverse reactions monitored were acute graft versus host disease and cytokine release syndrome.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Months
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: * Allogeneic transduced tV-CTLs with \>15% expression of 14g2a.zeta chimeric antigen receptor * Patient or responsible person must be able to understand and sign a permission/assent or consent form for infusion * Age 18 months through 17 years at time of relapse/progression * Life expectancy \>8weeks * Karnofsky score 60% or greater if 10 yrs old or older. Lansky score 60% or greater if under 10 yrs old * Patient must be HIV negative * ANC \>500 * Pulse ox\>90% on room air * AST/ALT/direct bili \<5x upper limit of normal * Recovered from toxic effects of all prior chemotherapy * Absence of human/anti-mouse antibody (HAMA) (patients who have received prior therapy with murine antibodies) * \>50% donor engraftment Exclusion Criteria: * Patient pregnant or lactating or refuses birth control methods * HIV positive * Uncontrolled intercurrent infection * Renal failure (creatinine clearance \<40ml/min/1.73m2) * Active hepatitis or cirrhosis with bilirubin, AST, ALT \>5xnormal * Rapidly progressive disease * Currently receiving any investigational drugs * Tumor potentially causing airway obstruction * Cardiomegaly or bilateral pulmonary infiltrates on CXR * Receiving \>0.25mg/kg/day methylprednisolone or equivalent systemic steroid. Topical steroid therapy is acceptable * Receiving more than one lymphocyte inhibiting agent (ex. Tacrolimus/CSA and MMF or other similar agent * Patients relapsing or progressing before the age of 18 months from Stage I/II disease, and/or those who, in the opinion of their oncologist, may benefit from further conventional therapy * Donor lymphocyte infusion in last 28 days * Evidence of GvHD greater than or equal to grade 2
References
Publications (0)
Data not yet available