Dual-Target GD2/B7-H3 CAR-NK Cells for Pediatric Relapsed or Refractory Neuroblastoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12-21
SponsorBeijing Biotech
About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- EB-DTNB-NK
- Fludarabine
- Cyclophosphamide
Treatment groups
36 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov