Phase 1, Open-label, Dose-escalation Trial with CD38-SADA:177 Lu-DOTA Drug Complex in Subjects with Relapsed or Refractory Non-Hodgkin Lymphoma
Phase 1
Recruiting
- Conditions
- Non-hodgkin Lymphoma
- Registration Number
- NCT05994157
- Lead Sponsor
- Y-mAbs Therapeutics
- 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 establish optimal and safe therapeutic doses and dosing schedule of CD38-SADA, and 177Lu-DOTA.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Tumor imaging and occurrence of dose limiting toxicities (DLT) during the DLT evaluation period (Part A) 4 weeks Occurrence of dose limiting toxicities during the DLT evaluation period (Part B) 4 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
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