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NCT05260957 · ClinicalTrials.gov registry record · Phase 2
CAR-T Cell Therapy, Mosunetuzumab and Polatuzumab for Treatment of Refractory/Relapsed Aggressive Non-Hodgkin's Lymphoma (NHL).
A Phase 2 study of Refractory Non-Hodgkin Lymphoma and Relapsed Non-Hodgkin Lymphoma, sponsored by Lazaros Lekakis.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT05260957: Recruiting Phase 2 study of Refractory Non-Hodgkin Lymphoma and Relapsed Non-Hodgkin Lymphoma, sponsored by Lazaros Lekakis.
NCT05260957 is a Phase 2 study of Refractory Non-Hodgkin Lymphoma and Relapsed Non-Hodgkin Lymphoma that is actively recruiting participants, run by Lazaros Lekakis. The registered enrollment target is 22 participants, below the 95-participant average among 17 other Refractory Non-Hodgkin Lymphoma trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05260957, a Phase 2 study of Refractory Non-Hodgkin Lymphoma and Relapsed Non-Hodgkin Lymphoma, is actively recruiting participants, sponsored by Lazaros Lekakis.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this research study is to test if a combination treatment of chimeric antigen receptor (CAR) T-cell therapy, Mosunetuzumab, and Polatuzumab Vedotin will result in tumor reduction.
Primary Outcome
Complete Response (CR) rate will be reported as the percentage of participants achieving complete response (CR) to study treatment. Response to therapy will be assessed using Positron Emission Tomography (PET)/ Computerized Tomography (CT) scan following Lugano 2014 criteria (Cheson et al, Journal of Clinical Oncology (JCO), 2014) at 3 months (Day +90) of study treatment. For equivocal PET-CT results, biopsy will be performed after day +90 PET/CT to assess true CR or persistent lymphoma.
Conditions Studied
Interventions
- DRUG Mosunetuzumab
- DRUG Polatuzumab
- BIOLOGICAL CAR-T Cell Therapy
Study Locations (1)
Florida
- University of Miami - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2022-12-14 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 2 |
What NCT05260957 shows while recruiting
NCT05260957 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 95-participant average among 17 other Refractory Non-Hodgkin Lymphoma trials with a reported enrollment target (77% lower).
The record links to 3 conditions, with Refractory Non-Hodgkin Lymphoma appearing as the primary indexed condition, and to 3 interventions - of which Mosunetuzumab is the first listed.
NCT05260957 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05260957 about?
NCT05260957 is a clinical study titled "CAR-T Cell Therapy, Mosunetuzumab and Polatuzumab for Treatment of Refractory/Relapsed Aggressive Non-Hodgkin's Lymphoma (NHL).". The purpose of this research study is to test if a combination treatment of chimeric antigen receptor (CAR) T-cell therapy, Mosunetuzumab, and Polatuzumab Vedotin will result in tumor reduction.
What is the current status of trial NCT05260957?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2022-12-14. Estimated completion is 2028-12-31.
What conditions does trial NCT05260957 study?
This clinical trial studies the following conditions: Refractory Non-Hodgkin Lymphoma, Relapsed Non-Hodgkin Lymphoma, Aggressive Non-Hodgkin Lymphoma.
What interventions are being tested in trial NCT05260957?
The interventions under investigation include: Mosunetuzumab (DRUG), Polatuzumab (DRUG), CAR-T Cell Therapy (BIOLOGICAL).
Who is sponsoring clinical trial NCT05260957?
This trial is sponsored by Lazaros Lekakis, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05260957 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05260957's enrollment target sits among peer trials
22 15th of 17 higher than 2 of 17 other Refractory Non-Hodgkin Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Refractory Non-Hodgkin Lymphoma 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.
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