Status:
RECRUITING
Phase 1, Open-label, Dose-escalation Trial with CD38-SADA:177 Lu-DOTA Drug Complex in Subjects with Relapsed or Refractory Non-Hodgkin Lymphoma
Lead Sponsor:
Y-mAbs Therapeutics
Conditions:
Non-hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 establis...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05994157
Start Date
February 1 2025
End Date
January 1 2028
Last Update
January 29 2025
Active Locations (6)
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1
HonorHealth
Scottsdale, Arizona, United States, 85258
2
City of Hope
Duarte, California, United States, 91010
3
Corewell Health-BAMF Health
Grand Rapids, Michigan, United States, 49503
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065