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NCT07003295 · ClinicalTrials.gov registry record · Phase 2
Testing the Anti-cancer Drug, Glofitamab, in Patients With Mantle Cell Lymphoma (A Type of Blood Cancer) Whose Disease Returned After CAR-T Cell Therapy
A Phase 2 study of Recurrent Mantle Cell Lymphoma and Refractory Mantle Cell Lymphoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT07003295 is a Phase 2 study of Recurrent Mantle Cell Lymphoma and Refractory Mantle Cell Lymphoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 20 participants, below the 37-participant average among 27 other Recurrent Mantle Cell Lymphoma trials with a reported enrollment target (46% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07003295, a Phase 2 study of Recurrent Mantle Cell Lymphoma and Refractory Mantle Cell Lymphoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial tests the safety and side effects of glofitamab and obinutuzumab and how well they work in treating patients with mantle cell lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory) after receiving CD19-directed chimeric antigen receptor (CAR) T-cell therapy. CAR T-cell therapy is a form of immunotherapy where the immune system cell, T-cell, is changed to attack cancer cells. Glofitamab is a bispecific antibody that can bind to two different antigens at the same time. Glofitamab binds to CD3, a protein found on T cells (a type of white blood cell), and CD20 a protein found on B cells (another type of white blood cell) and some lymphoma cells. This may help the immune system kill cancer cells. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving glofitamab and obinutuzumab may be safe, tolerable, and/or effective in treating patients with relapsed or refractory mantle cell lymphoma after receiving CD19-directed CAR T-cell therapy.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Positron Emission Tomography
- BIOLOGICAL Obinutuzumab
- BIOLOGICAL Glofitamab
Study Locations (1)
Maryland
- JHU Sidney Kimmel Comprehensive Cancer Center LAO - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2026-08-14 |
| Est. Completion | 2027-08-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07003295
The ClinicalTrials.gov registry entry for NCT07003295 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 37-participant average among 27 other Recurrent Mantle Cell Lymphoma trials with a reported enrollment target (46% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Recurrent Mantle Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT07003295 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT07003295 about?
NCT07003295 is a clinical study titled "Testing the Anti-cancer Drug, Glofitamab, in Patients With Mantle Cell Lymphoma (A Type of Blood Cancer) Whose Disease Returned After CAR-T Cell Therapy". This phase II trial tests the safety and side effects of glofitamab and obinutuzumab and how well they work in treating patients with mantle cell lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory) after receiving CD19-dir...
What is the current status of trial NCT07003295?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2026-08-14. Estimated completion is 2027-08-31.
What conditions does trial NCT07003295 study?
This clinical trial studies the following conditions: Recurrent Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma.
What interventions are being tested in trial NCT07003295?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Positron Emission Tomography (PROCEDURE), Obinutuzumab (BIOLOGICAL), Glofitamab (BIOLOGICAL).
Who is sponsoring clinical trial NCT07003295?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07003295 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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