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

Stopped early · Phase 1

Conditions studied: Non-hodgkin Lymphoma

In brief

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.

Key facts

Study ID

NCT05994157

Run by

Y-mAbs Therapeutics

People needed

1

Starts

2025-04-21

Expected to finish

2025-10-15

Last updated by the study team

2026-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
• Each subject must sign an ICF indicating that he or she understands the purpose of, and procedures required for the trial and is willing to participate in the trial.

You may not qualify if…

• Primary central nervous system lymphoma or known central nervous system involvement with lymphoma
• Systemic chemotherapy, radiotherapy, immunotherapy, or major surgery administered within 3 weeks (for nitrosoureas within 6 weeks) prior to the first dose of CD38-SADA
• Radioimmunotherapy within 100 days prior to the first dose of CD38-SADA
• 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
• >40% lymphoma bone marrow involvement

Where it is running

• HonorHealth — Scottsdale, Arizona, United States
• City of Hope — Duarte, California, United States
• Corewell Health-BAMF Health — Grand Rapids, Michigan, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Stony Brook Cancer Center — Stony Brook, New York, United States
• East Carolina University Leo W. Jenkins Cancer Center — Greenville, North Carolina, United States

Full record on ClinicalTrials.gov

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