Experimental lymphoma therapy tested in tiny early trial
NCT ID NCT05994157
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This phase 1 trial tested a two-step radioimmunotherapy (CD38-SADA and 177Lu-DOTA) in patients with relapsed or refractory non-Hodgkin lymphoma. The goal was to find safe doses and dosing schedules. Only 1 participant was enrolled, and the study was terminated early, so no conclusions about effectiveness can be drawn.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CD38-SADA and 177Lu-DOTA (two-step radioimmunotherapy)
- What this could lead to
- If it works, this could point toward a new treatment option for patients with hard-to-treat non-Hodgkin lymphoma.
- What could go wrong
- This was a very early, small phase 1 trial with only 1 participant, and it was terminated early. It is unclear if the approach is safe or effective, and it may not work in larger groups.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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1 person
The number who actually took part.
- Started
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Apr 2025
- Finished
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Oct 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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City of Hope
Duarte, California, 91010, United States
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Corewell Health-BAMF Health
Grand Rapids, Michigan, 49503, United States
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East Carolina University Leo W. Jenkins Cancer Center
Greenville, North Carolina, 27834, United States
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HonorHealth
Scottsdale, Arizona, 85258, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Stony Brook Cancer Center
Stony Brook, New York, 11794, United States
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