Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 1 study of Acute Lymphoblastic Leukemia and Small Lymphocytic Lymphoma, sponsored by National Cancer Institute (NCI).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Overall Response Rate will be evaluated using published criteria; these will be reported along with a 95% confidence interval
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 |
What NCT06364423 shows while recruiting
NCT06364423 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, below the 381-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (65% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Acute Lymphoblastic Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06364423's enrollment target sits among peer trials
132 40th of 131 higher than 92 of 131 other Acute Lymphoblastic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Lymphoblastic Leukemia 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
The Pediatric Acute Leukemia (PedAL) Screening Trial - A Study to Test Bone Marrow and Blood in Children With Leukemia That Has Come Back After Treatment or Is Difficult to Treat - A Leukemia & Lymphoma Society and Children's Oncology Group Study
RECRUITING · Phase 1
-
Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric Hematologic Malignancies and Solid Tumors
RECRUITING · Phase 1
-
UCD19 CAR T Therapy in Adults With B-ALL and MRD Positivity in CR1
RECRUITING · Phase 1
-
A Phase 1 Study of Orca-Q in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies
RECRUITING · Phase 1
-
225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome
RECRUITING · Phase 1
-
211^At-BC8-B10 Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, or Mixed-Phenotype Acute Leukemia
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01766297 · 132 participants · Phase 2
Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer
- NCT04002947 · 132 participants · Phase 2
Acalabrutinib With DA-EPOCH-R or R-CHOP for People With Untreated Diffuse Large B-cell Lymphoma
- NCT04128189 · 132 participants · Phase 3
Shingrix in Renal Transplant Recipients
- NCT04199780 · 132 participants · NA
Effects of tDCS Combined With CBI on Postsurgical Pain
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI