XCancer

Phase 1, Open-label, Dose-escalation Trial With CD38-SADA:177 Lu-DOTA Drug Complex in Subjects With Relapsed or Refractory Non-Hodgkin Lymphoma

Description:

Patients with non-Hodgkin Lymphoma will be treated with CD38-SADA:177Lu-DOTA complex (The IMP is a two-step radioimmunotherapy, delivered as two separate products CD38-SADA and 177Lu-DOTA) to establish optimal and safe therapeutic doses and dosing schedule of CD38-SADA, and 177Lu-DOTA.

Sponsor:

Y-mAbs Therapeutics, Inc.

Phase:

Phase 1

Government Study Link:

NCT05994157 - Click here to see study on

ClinicalTrials.gov

DOTA

Isotope(s):
Target(s):
  • No Explicit Target
Ligand Class: Small Molecules
Chelator: DOTA
Inclusion
  • Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
  • Target population must have relapsed, progressive or refractory non-hodgkin lymphoma and be ineligible for or have exhausted standard therapeutic options that may prolong survival
  • The subject must have fluoro-deoxyglucose (FDG)-avid lymphoma with measurable disease
  • CD38 positive tumor at most recent biopsy (new or archival) documented at central laboratory
Exclusion
  • \>40% lymphoma bone marrow involvement
  • Autologous stem cell transplantation within 42 days prior to the first dose of CD38-SADA
  • Treatment with approved CAR-T within 100 days prior to the first dose of CD38-SADA
  • Systemic chemotherapy, radiotherapy, immunotherapy, or major surgery administered within 3 weeks (for nitrosoureas within 6 weeks) prior to the first dose of CD38-SADA
  • Primary central nervous system lymphoma or known central nervous system involvement with lymphoma
  • Radioimmunotherapy within 100 days prior to the first dose of CD38-SADA