Clinical Trial · NCT05994157

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

Overview

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

ClinicalTrials.gov

NCT05994157

Drug / Compound

DOTA

Isotope(s):

Target(s):

No Explicit Target

Ligand Class: Small Molecules

Chelator: DOTA

Eligibility

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