Treatment for relapsed or refractory non-Hodgkin lymphoma using a new drug complex

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

This study is testing a new drug treatment for people with relapsed or hard-to-treat non-Hodgkin lymphoma to see if it can safely help them fight their cancer.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Y-mAbs Therapeutics (industry)
• Drugs / interventions: CAR-T, chemotherapy, immunotherapy
• Locations: 6 sites (Scottsdale, Arizona and 5 other locations)
• Trial ID: NCT05994157 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and optimal dosing of a new drug complex, CD38-SADA:177Lu-DOTA, in patients with relapsed or refractory non-Hodgkin lymphoma. The approach involves a two-step radioimmunotherapy, where patients receive two separate products to target their cancer. The study aims to establish effective therapeutic doses and a dosing schedule for this innovative treatment. Participants must have measurable disease and a CD38 positive tumor, and they will be monitored for safety and efficacy throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are individuals with relapsed, progressive, or refractory non-Hodgkin lymphoma who have exhausted standard treatment options.

Not a fit: Patients with primary central nervous system lymphoma or those who have received recent systemic therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with limited treatment choices for non-Hodgkin lymphoma.

How similar studies have performed: While this approach is innovative, similar studies using radioimmunotherapy have shown promise in treating other types of lymphoma.

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

Where this trial is running

Scottsdale, Arizona and 5 other locations

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

Study contacts

• Study coordinator: Joris Wilms

Conditions: Non-hodgkin Lymphoma