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NCT05418088 · ClinicalTrials.gov registry record · Phase 1
Genetically Engineered Cells (Anti-CD19/CD20/CD22 CAR T-cells) for the Treatment of Relapsed or Refractory Lymphoid Malignancies
A Phase 1 study of Refractory Acute Lymphoblastic Leukemia and Recurrent Chronic Lymphocytic Leukemia, sponsored by Sumithira Vasu.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
- 2
- Study locations
NCT05418088 is a Phase 1 study of Refractory Acute Lymphoblastic Leukemia and Recurrent Chronic Lymphocytic Leukemia that is actively recruiting participants, run by Sumithira Vasu. The registered enrollment target is 54 participants, above the 42-participant average among 21 other Refractory Acute Lymphoblastic Leukemia trials with a reported enrollment target (29% higher). The trial reports 2 study locations across 1 state.
The verdict
NCT05418088, a Phase 1 study of Refractory Acute Lymphoblastic Leukemia and Recurrent Chronic Lymphocytic Leukemia, is actively recruiting participants, sponsored by Sumithira Vasu.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase I trial tests the safety, side effects and best infusion dose of genetically engineered cells called anti-CD19/CD20/CD22 chimeric antigen receptor (CAR) T-cells following a short course of chemotherapy with cyclophosphamide and fludarabine in treating patients with lymphoid cancers (malignancies) that have come back (recurrent) or do not respond to treatment (refractory). Lymphoid malignancies eligible for this trial are: non-Hodgkin lymphoma (NHL), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), and B-prolymphocytic leukemia (B-PLL). T-cells (a type of white blood cell) form part of the body's immune system. CAR-T is a type of cell therapy that is used with gene-based therapies. CAR T-cells are made by taking a patient's own T-cells and genetically modifying them with a virus so that they are recognized by a group of proteins called CD19/CD20/CD22 which are found on the surface of cancer cells. Anti-CD19/CD20/CD22 CAR T-cells can recognize CD19/CD20/CD22, bind to the cancer cells and kill them. Giving combination chemotherapy helps prepare the body before CAR T-cell therapy. Giving CAR-T after cyclophosphamide and fludarabine may kill more tumor cells.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- PROCEDURE Echocardiography
- DRUG Fludarabine Phosphate
- PROCEDURE Multigated Acquisition Scan
- BIOLOGICAL Anti-CD19/CD20/CD22 CAR T-Cells
Study Locations (2)
Ohio
- Nationwide Children's Hospital - Columbus
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2022-06-30 |
| Est. Completion | 2026-07-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05418088
The ClinicalTrials.gov registry entry for NCT05418088 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 42-participant average among 21 other Refractory Acute Lymphoblastic Leukemia trials with a reported enrollment target (29% higher). The listed sponsor is Sumithira Vasu, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Refractory Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT05418088 reports 2 study locations spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT05418088 about?
NCT05418088 is a clinical study titled "Genetically Engineered Cells (Anti-CD19/CD20/CD22 CAR T-cells) for the Treatment of Relapsed or Refractory Lymphoid Malignancies". This phase I trial tests the safety, side effects and best infusion dose of genetically engineered cells called anti-CD19/CD20/CD22 chimeric antigen receptor (CAR) T-cells following a short course of chemotherapy with cyclophosphamide and fludarabine in treating patients with lymphoid cancers (malig...
What is the current status of trial NCT05418088?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2022-06-30. Estimated completion is 2026-07-31.
What conditions does trial NCT05418088 study?
This clinical trial studies the following conditions: Refractory Acute Lymphoblastic Leukemia, Recurrent Chronic Lymphocytic Leukemia, Recurrent Acute Lymphoblastic Leukemia, Recurrent B Acute Lymphoblastic Leukemia, Recurrent Non-Hodgkin Lymphoma.
What interventions are being tested in trial NCT05418088?
The interventions under investigation include: Cyclophosphamide (DRUG), Echocardiography (PROCEDURE), Fludarabine Phosphate (DRUG), Multigated Acquisition Scan (PROCEDURE), Anti-CD19/CD20/CD22 CAR T-Cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT05418088?
This trial is sponsored by Sumithira Vasu, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05418088 being conducted?
This trial has 2 study locations across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Refractory Acute Lymphoblastic Leukemia
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.