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NCT05432635 · ClinicalTrials.gov registry record · Phase 1
Genetically Modified T-cells (CMV-Specific CD19-CAR T-cells) Plus a Vaccine (CMV-MVA Triplex) Following Stem Cell Transplantation for the Treatment of Intermediate or High Grade B-cell Non-Hodgkin Lymphoma
A Phase 1 study of Diffuse Large B Cell Lymphoma and Mantle Cell Lymphoma, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT05432635: Recruiting Phase 1 study of Diffuse Large B Cell Lymphoma and Mantle Cell Lymphoma, sponsored by City of Hope Medical Center.
NCT05432635 is a Phase 1 study of Diffuse Large B Cell Lymphoma and Mantle Cell Lymphoma that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 15 participants, below the 219-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05432635, a Phase 1 study of Diffuse Large B Cell Lymphoma and Mantle Cell Lymphoma, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the safety and side effects of cytomegalovirus (CMV) specific CD19-chimeric antigen receptor (CAR) T-cells along with the CMV-modified vaccinia Ankara (MVA) triplex vaccine following a stem cell transplant in treating patients with high grade B-cell non-Hodgkin lymphoma. CAR T-cells are a type of treatment in which a patient's T-cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T-cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T-cells are grown in the laboratory and given to the patient by infusion. Vaccines such as CMV-MVA triplex are made from gene-modified viruses and may help the body build an effective immune response to kill cancer cells. Giving CMV-specific CD19-CAR T-cells plus the CMV-MVA triplex vaccine following a stem cell transplant may help prevent the cancer from coming back.
Primary Outcome
Will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 from data obtained at each clinical assessment. Will be summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment and reversibility or outcome.
Conditions Studied
Interventions
- BIOLOGICAL Anti-CD19-CAR CMV-specific T-lymphocytes
- PROCEDURE Autologous Hematopoietic Stem Cell Transplantation
- BIOLOGICAL Multi-peptide CMV-Modified Vaccinia Ankara Vaccine
- PROCEDURE Myeloablative Conditioning
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2023-08-01 |
| Est. Completion | 2028-12-30 |
| Phase | Phase 1 |
What NCT05432635 shows while recruiting
NCT05432635 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 219-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (93% lower).
The record links to 8 conditions, with Diffuse Large B Cell Lymphoma appearing as the primary indexed condition, and to 4 interventions - of which Anti-CD19-CAR CMV-specific T-lymphocytes is the first listed.
NCT05432635 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05432635 about?
NCT05432635 is a clinical study titled "Genetically Modified T-cells (CMV-Specific CD19-CAR T-cells) Plus a Vaccine (CMV-MVA Triplex) Following Stem Cell Transplantation for the Treatment of Intermediate or High Grade B-cell Non-Hodgkin Lymphoma". This phase I trial studies the safety and side effects of cytomegalovirus (CMV) specific CD19-chimeric antigen receptor (CAR) T-cells along with the CMV-modified vaccinia Ankara (MVA) triplex vaccine following a stem cell transplant in treating patients with high grade B-cell non-Hodgkin lymphoma. C...
What is the current status of trial NCT05432635?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2023-08-01. Estimated completion is 2028-12-30.
What conditions does trial NCT05432635 study?
This clinical trial studies the following conditions: Diffuse Large B Cell Lymphoma, Mantle Cell Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Mantle Cell Lymphoma, B-Cell Non-Hodgkin Lymphoma.
What interventions are being tested in trial NCT05432635?
The interventions under investigation include: Anti-CD19-CAR CMV-specific T-lymphocytes (BIOLOGICAL), Autologous Hematopoietic Stem Cell Transplantation (PROCEDURE), Multi-peptide CMV-Modified Vaccinia Ankara Vaccine (BIOLOGICAL), Myeloablative Conditioning (PROCEDURE).
Who is sponsoring clinical trial NCT05432635?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05432635 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05432635's enrollment target sits among peer trials
15 100th of 114 higher than 12 of 114 other Diffuse Large B Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diffuse Large B Cell 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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