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NCT06364423 · ClinicalTrials.gov registry record · Phase 1
Anti-CD19 Chimeric Antigen Receptor T-Cell Immunotherapy for Leukemias
A Phase 1 study of Acute Lymphoblastic Leukemia and Small Lymphocytic Lymphoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 132
- Enrollment target
- 1
- Study location
NCT06364423 is a Phase 1 study of Acute Lymphoblastic Leukemia and Small Lymphocytic Lymphoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 132 participants, below the 381-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06364423, a Phase 1 study of Acute Lymphoblastic Leukemia and Small Lymphocytic Lymphoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 132 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Chronic lymphocytic leukemia (CLL),small lymphocytic lymphoma (SLL) and B-cell acute lymphoblastic leukemia or lymphoma (ALL) are blood cancers that affect certain white blood cells. Advanced forms of these diseases are difficult to treat. CD19 is a protein often found on the surfaces of these cancer cells. Researchers can modify a person's own immune cells (T cells) to target CD19. When these modified T cells are returned to the body-a treatment called anti-CD19 chimeric antigen receptor (CAR) T cell therapy-they may help kill cancer cells. Objective: To test anti-CD19 CAR T cell therapy in people with CLL or SLL and ALL. Eligibility: People aged 18 years and older with CLL or SLL and ALL that has not been controlled with standard drugs. Design: Participants will be screened. They will have imaging scans and tests of their heart function. If a sample of tissue from their tumor is not available, a new one may be taken; the sample will be tested for CD19. Participants will receive a drug to reduce the leukemia cells in their blood. Then they will undergo apheresis: Blood will be taken from the body through a needle. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different needle. The collected T cells will be gene edited to make them attack cells with CD19. Participants will take drugs to prepare them for treatment for 3 days. These drugs will start 5 days before the treatment. Then their own modified CAR T cells will be returned to their bloodstream. Participants will stay in the hospital for at least 9 days after the treatment. Follow-up visits will continue for 5 years.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Rituximab
- BIOLOGICAL Autologous HuCD19 ( Anti-CD19)CAR T cells
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2024-09-03 |
| Est. Completion | 2030-07-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06364423
The ClinicalTrials.gov registry entry for NCT06364423 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 381-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (65% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 7 conditions, with Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT06364423 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT06364423 about?
NCT06364423 is a clinical study titled "Anti-CD19 Chimeric Antigen Receptor T-Cell Immunotherapy for Leukemias". Background: Chronic lymphocytic leukemia (CLL),small lymphocytic lymphoma (SLL) and B-cell acute lymphoblastic leukemia or lymphoma (ALL) are blood cancers that affect certain white blood cells. Advanced forms of these diseases are difficult to treat. CD19 is a protein often found on the surfaces o...
What is the current status of trial NCT06364423?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 132 participants. The study started on 2024-09-03. Estimated completion is 2030-07-01.
What conditions does trial NCT06364423 study?
This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia, Small Lymphocytic Lymphoma, Lymphoblastic Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, B-cell Chronic Lymphocytic Leukemia.
What interventions are being tested in trial NCT06364423?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Rituximab (DRUG), Autologous HuCD19 ( Anti-CD19)CAR T cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT06364423?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06364423 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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