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NCT06209619 · ClinicalTrials.gov registry record · Phase 1
CC-99282 + Rituximab Early Post CART for Non-Hodgkin's Lymphoma
A Phase 1 study of Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma-Recurrent and Primary Mediastinal Large B-Cell Lymphoma Recurrent, sponsored by Nathan Denlinger.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT06209619: Recruiting Phase 1 study of Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma-Recurrent and Primary Mediastinal Large B-Cell Lymphoma Recurrent, sponsored by Nathan Denlinger.
NCT06209619 is a Phase 1 study of Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma-Recurrent and Primary Mediastinal Large B-Cell Lymphoma Recurrent that is actively recruiting participants, run by Nathan Denlinger. The registered enrollment target is 18 participants, below the 132-participant average among 4 other Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma-Recurrent trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06209619, a Phase 1 study of Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma-Recurrent and Primary Mediastinal Large B-Cell Lymphoma Recurrent, is actively recruiting participants, sponsored by Nathan Denlinger.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial tests the safety, side effects and best dose of CC-99282 with rituximab for the treatment of patients who have received chimeric antigen receptor (CAR) T cell therapy for non-Hodgkins lymphoma and in whom have had a sub-optimal response early on to CAR T-cell therapy. Immunotherapy with CC-99282 may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving CC-99282 with rituximab may be a safe and effective treatment option for patients who have received CAR-T cell therapy for relapsed or refractory non-Hodgkin's lymphoma.
Primary Outcome
Will describe frequency and nature of adverse events associated with CC-99282 + rituximab post CD19 chimeric antigen receptor (CAR) -T cell therapy using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy
- PROCEDURE Positron Emission Tomography
- DRUG Golcadomide
Study Locations (1)
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2024-01-29 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What NCT06209619 shows while recruiting
NCT06209619 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 132-participant average among 4 other Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma-Recurrent trials with a reported enrollment target (86% lower).
The record links to 10 conditions, with Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma-Recurrent appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06209619 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT06209619 about?
NCT06209619 is a clinical study titled "CC-99282 + Rituximab Early Post CART for Non-Hodgkin's Lymphoma". This phase I trial tests the safety, side effects and best dose of CC-99282 with rituximab for the treatment of patients who have received chimeric antigen receptor (CAR) T cell therapy for non-Hodgkins lymphoma and in whom have had a sub-optimal response early on to CAR T-cell therapy. Immunotherap...
What is the current status of trial NCT06209619?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2024-01-29. Estimated completion is 2026-12-31.
What conditions does trial NCT06209619 study?
This clinical trial studies the following conditions: Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma-Recurrent, Primary Mediastinal Large B-Cell Lymphoma Recurrent, Diffuse Large B-Cell Lymphoma-Refractory, B-Cell Non-Hodgkin Lymphoma-Recurrent, Diffuse Large B-Cell Lymphoma-Recurrent.
What interventions are being tested in trial NCT06209619?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy (PROCEDURE), Positron Emission Tomography (PROCEDURE), Golcadomide (DRUG).
Who is sponsoring clinical trial NCT06209619?
This trial is sponsored by Nathan Denlinger, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06209619 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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