OncoMatch/Clinical Trials/NCT06364423
Anti-CD19 Chimeric Antigen Receptor T-Cell Immunotherapy for Leukemias
Is NCT06364423 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Autologous HuCD19 ( Anti-CD19)CAR T cells and Cyclophosphamide for leukemia, lymphocytic, chronic, b-cell.
Treatment: Autologous HuCD19 ( Anti-CD19)CAR T cells · Cyclophosphamide · Fludarabine · Rituximab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Chronic Lymphocytic Leukemia
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 uniform expression (uniform; no CD19-negative populations)
Demonstration of CD19 expression on CLL/SLL or ALL, as assessed by the NCI Laboratory of Pathology or NIH Department of Laboratory Medicine Hematopathology section. For participants with pathologically confirmed Richter s transformation, the transformed cells must also have CD19 expression. CD19 expression must be uniform meaning no populations of clearly CD19-negative CLL/SLL, Richter s or ALL cells are observed.
Required: CD20 expression on >= 20% of malignant cells (>= 20% of malignant cells)
CD20 must be detected on >= 20% of malignant cells by flow cytometry or immunohistochemistry.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: Bruton tyrosine kinase inhibitor — CLL/SLL
Participants with CLL/SLL must have received at least two prior treatment regimens, at least one of which must have contained a Bruton s tyrosine kinase (BTK) inhibitor. Participants who took a BTK inhibitor but stopped due to intolerance are potentially eligible.
Must have received: systemic therapy — ALL
Participants with refractory ALL that failed induction or participants with relapsed ALL after a standard induction regimen or after any later line of therapy are eligible. Participants with relapsed or refractory ALL after alloHSCT are eligible.
Cannot have received: CAR T-cell therapy
Participants who have had prior CAR T-cell therapy.
Cannot have received: checkpoint inhibitor (pembrolizumab, nivolumab)
Checkpoint inhibitor drugs such as pembrolizumab or nivolumab or other antibodies targeting PD-1 or PDL-1 within 180 days of pre-leukapheresis rituximab.
Cannot have received: antibodies targeting CD19
Exception: at least sixty days must elapse between therapy with antibodies targeting CD19 and CAR T-cell infusion
For participants who have received antibodies targeting CD19, at least sixty days must elapse between therapy with antibodies targeting CD19 and CAR T-cell infusion.
Lab requirements
Blood counts
ANC >= 1,000/mcL without growth factors in prior 10 days; platelets >= 50,000/mcL without transfusion; hemoglobin >= 8 g/dL
Kidney function
serum creatinine < 1.5x ULN; if >= 1.5x ULN, eGFR >= 50 mL/min/1.73m^2 by 2021 CKD-EPI equation
Liver function
total bilirubin <= 2.0 mg/dL; ALT and AST <= 3x ULN (<= 5x ULN if liver involvement)
Cardiac function
ejection fraction >= 50% by echocardiography and no evidence of hemodynamically significant pericardial effusion
Participants must have adequate organ and marrow function as defined below: ANC >= 1,000/mcL without the support of filgrastim or other growth factors in the 10 days prior to screening assessment; platelets >= 50,000/mcL without transfusion support; hemoglobin >= 8 g/dL; total bilirubin <= 2.0 mg/dL; ALT or AST <= 3x ULN unless liver involvement by malignancy is demonstrated. If liver involvement with malignancy is detected, ALT and AST must be <= 5x ULN; Serum creatinine < 1.5 X institutional ULN. Participants with serum creatinine >= 1.5 X institutional ULN may participate if serum creatinine eGFR is >=50 mL/min/1.73m^2 by 2021 CKD-EPI equation. Cardiac ejection fraction of >= 50% by echocardiography and no evidence of hemodynamically significant pericardial effusion.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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