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Die klinische Studie NCT07502287 (DUAL-NK-NB) für Rückfälliges Neuroblastom, Therapieresistentes Neuroblastom, Hochrisiko-Neuroblastom, Ganglioneuroblastom ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
Dual-Target GD2/B7-H3 CAR-NK Cells for Pediatric Relapsed or Refractory Neuroblastoma (DUAL-NK-NB) Phase 1, Phase 2 36 Pädiatrisch
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT07502287 (DUAL-NK-NB) untersucht Behandlung im Zusammenhang mit Rückfälliges Neuroblastom, Therapieresistentes Neuroblastom, Hochrisiko-Neuroblastom, Ganglioneuroblastom. Diese interventionsstudie der Phase 1 Phase 2 hat den Status offene rekrutierung und startete am 2. März 2026. Es ist geplant, 36 Teilnehmer aufzunehmen. Durchgeführt von Beijing Biotech wird der Abschluss für 17. Juni 2028 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 30. März 2026 aktualisiert.
Kurzbeschreibung
This illustrative Phase 1/Phase 2 study tests allogeneic dual-target GD2/B7-H3 (CD276) CAR-NK cells in children and young adults with relapsed or refractory neuroblastoma. After lymphodepletion, participants receive IV CAR-NK cells;Part A defines the RP2D and Part B estimates preliminary activity
Ausführliche Beschreibung
The investigational product in this example is a cord blood-derived allogeneic NK-cell therapy engineered to express a dual-target CAR recognizing GD2 and B7-H3, supported by IL-15 to improve short-term persistence and equipped with an inducible safety switch. The study is designed as a multicenter Phase 1/Phase 2 protocol: Part A uses a standard 3+3 dose-escalation approach across predefined dose levels, and Part B ...Mehr anzeigen
Offizieller Titel
A Phase 1/Phase 2, Open-Label Study of BiomarkerInformed, Allogeneic Dual-Target GD2/B7-H3 (CD276) CAR-NK Cells in Children and Young Adults With Relapsed or Refractory Neuroblastoma
Erkrankungen
Rückfälliges NeuroblastomTherapieresistentes NeuroblastomHochrisiko-NeuroblastomGanglioneuroblastomWeitere Studien-IDs
- DUAL-NK-NB
- EB-CARNK-CRC-103
NCT-Nummer
Studienbeginn (tatsächlich)
2026-03-02
Zuletzt aktualisiert
2026-03-30
Studienende (vorauss.)
2028-06-17
Geplante Rekrutierung
36
Studientyp
Interventionsstudie
PHASE
Phase 1
Phase 2
Phase 2
Status
Offene Rekrutierung
Stichwörter
pediatric neuroblastoma
CAR-NK
GD2
B7-H3
CD276
dual-targeting
relapsed/refractory
allogeneic
solid tumor immunotherapy
cell therapy
biomarkerinformed design
CAR-NK
GD2
B7-H3
CD276
dual-targeting
relapsed/refractory
allogeneic
solid tumor immunotherapy
cell therapy
biomarkerinformed design
Primäres Ziel
Behandlung
Zuteilungsmethode
Nicht zutreffend
Interventionsmodell
Einarmige Studie
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellEB-DTNB-NK Participants receive protocol-defined fludarabine/cyclophosphamide lymphodepletion followed by intravenous allogeneic dual-target GD2/B7-H3 CAR-NK cells on Day 0 at the assigned dose level or RP2D. Additional doses on Days 7 and 14 are permitted if predefined safety criteria are met and there is no prohibitive toxicity or rapid progression. | EB-DTNB-NK Allogeneic, cord blood-derived NK cells engineered with a dual-target CAR recognizing GD2 and B7-H3 (CD276), with IL-15 support and an inducible safety switch; administered intravenously on Day 0 with optional repeat dosing on Days 7 and 14 if tolerated. Fludarabin Lymphodepleting chemotherapy administered before CAR-NK infusion according to the protocol-defined conditioning regimen. Cyclophosphamide Lymphodepleting chemotherapy administered before CAR-NK infusion according to the protocol-definedb conditioning regimen. |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Incidence of dose-limiting toxicities (DLTs) after first CARNK infusion, using protocol-defined DLT criteria. | 28 days | |
Incidence and severity of treatment-emergent adverse events | Incidence and severity of treatment-emergent adverse events, including CRS and ICANS, graded using CTCAE v5.0 and ASTCT consensus criteria. | 12 months |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Objective response rate by revised International Neuroblastoma Response Criteria (rINRC). | 12 months | |
Duration of response among responders | 24 months | |
Progression-free survival | 12 months | |
Overall survival | 24 months |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Kind, Erwachsene
Mindestalter
12 Months
Zugelassene Geschlechter
Alle
- Age 12 months to 21 years at consent/assent.
- Histologically confirmed neuroblastoma or ganglioneuroblastoma with relapsed, refractory, progressive, or persistent high-risk disease for which no curative standard option is available.
- Measurable or evaluable disease according to revised International Neuroblastoma Response Criteria (rINRC), including MIBG-avid disease, CT/MRI-evaluable soft-tissue disease, and/or bone marrow disease.
- Tumor material available for central assessment of GD2 and B7-H3 expression; at least one target must be positive.
GD2 is treated as the core target and B7-H3 as the complementary target for correlative target-prioritization analyses.
- Prior exposure to standard neuroblastoma therapy, including anti-GD2-based therapy, unless contraindicated, unavailable, or declined for a documented medical reason.
- Lansky or Karnofsky performance score >= 50.
- Life expectancy >= 8 weeks.
- Recovery from clinically significant acute toxicities of prior therapy and protocol-defined washout from chemotherapy, biologics, radiation, and prior cell therapy.
- Adequate organ function: hematologic, renal, hepatic, cardiac, and pulmonary function considered sufficient by protocoldefined laboratory and clinical thresholds.
- Negative pregnancy test for patients of childbearing potential and agreement to use effective contraception during the protocol-defined period.
- Written informed consent from parent/legal guardian and assent from the participant when appropriate.
- Active uncontrolled infection, including bacteremia, uncontrolled viral infection, or invasive fungal disease.
- Pregnancy or breastfeeding.
- Active grade >= 2 graft-versus-host disease, or systemic immunosuppression for treatment/prevention of graft-versushost disease within the protocol-defined washout period after prior allogeneic transplant.
- Symptomatic or unstable central nervous system disease requiring urgent medical intervention.
- Prior genetically modified cellular therapy within the protocol-defined washout window, or unresolved clinically significant toxicity from prior cell therapy.
- Active autoimmune disease requiring systemic immunosuppressive therapy.
- Clinically significant uncontrolled cardiovascular, pulmonary, hepatic, renal, or neurologic disorder that would increase study risk.
- Known hypersensitivity to fludarabine, cyclophosphamide, study-product components, or supportive-care medications required by the protocol.
- Known uncontrolled HIV infection or uncontrolled hepatitis B or C.
- Any medical, psychosocial, or logistical condition that, in the investigator's judgment, would make study participation unsafe or would impair protocol adherence.
Beijing BiotechZentrale Studienkontakte
Kontakt: Seni S Lu, Phd, +86 13076790030, [email protected]
1 Studienstandorte in 1 Ländern
Guangdong
Peking University Shenzhen Hospital, Shenzhen, Guangdong, 518036, China
Zhen J Peng, Phd, Kontakt, +86 13076790039, [email protected]
Offene Rekrutierung