Non Hodgkin Lymphoma Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT05994157

Recruitment Status:

Not yet recruiting

Sponsor:

Y-mAbs Therapeutics

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There are 6 Locations for this study

See Locations Near You

HonorHealth
Scottsdale Arizona, 85258, United States
City of Hope
Duarte California, 91010, United States
Corewell Health-BAMF Health
Grand Rapids Michigan, 49503, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Stony Brook Cancer Center
Stony Brook New York, 11794, United States
East Carolina University Leo W. Jenkins Cancer Center
Greenville North Carolina, 27834, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT05994157

Recruitment Status:

Not yet recruiting

Sponsor:


Y-mAbs Therapeutics

How clear is this clinincal trial information?

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