Phase 1, Open-label, Dose-escalation Trial with CD38-SADA:177 Lu-DOTA Drug Complex in Subjects with Relapsed or Refractory Non-Hodgkin Lymphoma
NCT ID: NCT05994157
Last Updated: 2025-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
30 participants
INTERVENTIONAL
2025-02-28
2028-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CD38-SADA:177Lu-DOTA Complex
CD38-SADA:177Lu-DOTA Complex
The IMP is a two-step radioimmunotherapy, delivered as two separate products CD38-SADA and 177Lu-DOTA. Both will be administered as an IV infusions.
Interventions
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CD38-SADA:177Lu-DOTA Complex
The IMP is a two-step radioimmunotherapy, delivered as two separate products CD38-SADA and 177Lu-DOTA. Both will be administered as an IV infusions.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Y-mAbs Therapeutics
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Other Identifiers
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1201
Identifier Type: -
Identifier Source: org_study_id
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