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NCT07676877 · ClinicalTrials.gov registry record · Phase 1
Lymphodepletion With Low Dose Total Body Irradiation Before Standard of Care Tisagenlecleucel for the Treatment of Relapsed and Recurrent Large B-cell Lymphoma
A Phase 1 study, sponsored by Nathan Denlinger.
- Not yet
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT07676877 is a Phase 1 study that has not yet begun recruiting, run by Nathan Denlinger. The registered enrollment target is 18 participants.
The verdict
NCT07676877, a Phase 1 study, has not yet begun recruiting, sponsored by Nathan Denlinger.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
This phase I trial tests the safety, side effects, and best dose of total body irradiation (TBI) in combination with standard of care lymphodepletion with cyclophosphamide and fludarabine before tisagenlecleucel (Tisa-cel) and how well the combination works in patients with large B-cell lymphoma (LBCL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). TBI is a common treatment that sends radiation (for example, through x-rays) to the entire body. Lymphodepleting chemotherapy, such as cyclophosphamide and fludarabine, along with TBI helps kill cancer cells in the body and helps prepare the body for the Tisa-cel infusion. Tisagenlecleucel is made using a patient's T cells (a type of immune system cell). A gene for a special receptor called chimeric antigen receptor (CAR) is added to the T cells in the laboratory. These changed T cells called CAR T cells are grown in large numbers in the laboratory and given to the patient by infusion. Tisa-cel binds to a protein called CD19, which is found on some leukemia and lymphoma cells. This helps the body's immune system kill cancer cells. Tisa-cel is a type of CAR T-cell therapy. Giving low dose TBI in combination with standard of care lymphodepletion therapy and Tisa-cel may be safe, tolerable, and/or effective in treating patients with relapsed or refractory (R/R) LBCL.
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Leukapheresis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2026-09-01 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07676877
The ClinicalTrials.gov registry entry for NCT07676877 describes a study currently listed as not yet recruiting, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nathan Denlinger, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT07676877 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07676877 about?
NCT07676877 is a clinical study titled "Lymphodepletion With Low Dose Total Body Irradiation Before Standard of Care Tisagenlecleucel for the Treatment of Relapsed and Recurrent Large B-cell Lymphoma". This phase I trial tests the safety, side effects, and best dose of total body irradiation (TBI) in combination with standard of care lymphodepletion with cyclophosphamide and fludarabine before tisagenlecleucel (Tisa-cel) and how well the combination works in patients with large B-cell lymphoma (LB...
What is the current status of trial NCT07676877?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2026-09-01. Estimated completion is 2027-12-31.
What interventions are being tested in trial NCT07676877?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Leukapheresis (PROCEDURE).
Who is sponsoring clinical trial NCT07676877?
This trial is sponsored by Nathan Denlinger, which has 2 total clinical trials registered on ClinicalTrials.gov.
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