OncoMatch/Clinical Trials/NCT06364423
Anti-CD19 Chimeric Antigen Receptor T-Cell Immunotherapy for Leukemias
Is NCT06364423 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
Chemotherapy
Other
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)
Demographics
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06364423 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CAR T-cell therapy, checkpoint inhibitor, antibodies targeting CD19 disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 uniform expression is a required biomarker for enrollment.
Does this trial require CD20?
Yes, CD20 expression on >= 20% of malignant cells is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 120 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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