Safety, Tolerability, and Preliminary Efficacy of [211At]MABG in Patients With Relapsed or Refractory Neuroblastoma

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age1-100
SponsorSichuan University

About this trial

Fractionated dosing of \[211At\]MABG Radiotherapy in Relapsed/Refractory Neuroblastoma

Eligibility criteria

Qualifiers

Patients diagnosed with MIBG avid lesions, high-risk neuroblastoma per the Revised International Neuroblastoma Response Criteria (Revised INRC), with refractory, relapsed, or progressive disease.

All measurable soft tissue lesions must be MIBG-avid.

Age ≥ 1 year at enrollment.

Lansky performance status ≥ 50%.

Disqualifiers

Antibody-based immunotherapy within fewer than 5 half-lives or 30 days (whichever is shorter), or who have not yet recovered from adverse effects of any biologic therapy.

Treatment with [¹³¹I]MIBG or Lu177 targeted radionuclide therapy less than 3 months of last administration.

Autologous stem cell transplant <12 weeks, or Allogeneic stem cell transplant <4 months (patients >4 months post-transplant must be free of active GVHD).

Radiotherapy within 2 weeks prior to the first study dose (However, patients with a single-site irradiation that remains MIBG avid may be enrolled.) or extensive-field radiotherapy (e.g., craniospinal, whole abdomen, whole lung, or >50% of bone marrow area) within 12 weeks prior to the first study dose.

Trial design

Treatments tested in this trial

  • [211At]MABG

Treatment groups

10 Participants
are divided into 1 treatment group

Sponsors and collaborators