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NCT07225439 · ClinicalTrials.gov registry record · Phase 1
Rituximab (Rtx) + Tafasitamab in Combination With Allogeneic NK Cells for Treatment of Relapsed/Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL)
A Phase 1 study, sponsored by Paolo Caimi, MD.
- Not yet
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT07225439: Clinical Trial Phase 1 study, sponsored by Paolo Caimi, MD.
NCT07225439 is a Phase 1 study that has not yet begun recruiting, run by Paolo Caimi, MD. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07225439, a Phase 1 study, has not yet begun recruiting, sponsored by Paolo Caimi, MD.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
This research study is for people who have relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL) that has not responded to two or more lines of therapy. The purpose of this study is to identify the recommended dose of allogeneic NK cells in combination with IL-2, Tafasitamab and Rituximab for the treatment of relapsed or refractory B-cell non-Hodgkin's lymphoma. NK cells are an investigational (experimental) treatment which means they are not approved by the Food and Drug Administration (FDA). NK cells are a type of lymphocyte that's part of the body's natural immune system, and they can kill cancer cells by creating pores in the cancer cell membranes and inducing apoptosis (programmed cell death). Participants in this study will receive lymphodepleting chemotherapy, as well as Allogeneic NK cells, Tafasitamab and Interleukin-2 (IL-2) by an intravenous (IV) infusion. Participants are expected to complete one cycle, and they may be eligible to complete a second cycle of the same regiment if they have stable disease, partial or complete remission at the end of the first cycle. Participants will be in this study for about 12 months.
Primary Outcome
Non hematologic AEs will be measured during cycle 1 (first 28 days) and hematologic AEs will be measured during the first 42 days for all dose levels. DLTs are graded for severity by the Common Terminology Criteria for Adverse Events v5.0 (CTCAEv5.0) criteria.
Interventions
- DRUG Rituximab
- DRUG Interleukin-2
- DRUG Tafasitamab
- DRUG Allogeneic NK cells
- DRUG Fludarabine/cyclophosphamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2026-09 |
| Est. Completion | 2027-12 |
| Phase | Phase 1 |
What is known before NCT07225439 opens enrollment
NCT07225439 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 5 interventions - of which Rituximab is the first listed.
NCT07225439 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07225439 about?
NCT07225439 is a clinical study titled "Rituximab (Rtx) + Tafasitamab in Combination With Allogeneic NK Cells for Treatment of Relapsed/Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL)". This research study is for people who have relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL) that has not responded to two or more lines of therapy. The purpose of this study is to identify the recommended dose of allogeneic NK cells in combination with IL-2, Tafasitamab and Rituximab for t...
What is the current status of trial NCT07225439?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2026-09. Estimated completion is 2027-12.
What interventions are being tested in trial NCT07225439?
The interventions under investigation include: Rituximab (DRUG), Interleukin-2 (DRUG), Tafasitamab (DRUG), Allogeneic NK cells (DRUG), Fludarabine/cyclophosphamide (DRUG).
Who is sponsoring clinical trial NCT07225439?
This trial is sponsored by Paolo Caimi, MD, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07225439's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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