Actively Recruiting
Anti-CD19 Chimeric Antigen Receptor T-Cell Immunotherapy for Leukemias
Led by National Cancer Institute (NCI) · Updated on 2026-05-04
132
Participants Needed
1
Research Sites
303 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Anti-CD19 Chimeric Antigen Receptor T-Cell Immunotherapy for Leukemias
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of CLL, SLL, or B-cell acute lymphoblastic leukemia or lymphoma (ALL), including Richter's transformation with confirmed CD19 expression
- Uniform CD19 expression and CD20 expression on at least 20% of malignant cells
- Age 18 years or older
- Measurable malignancy by CT scan or flow cytometry in bone marrow or blood
- Creatinine less than 1.5 times institutional upper limit of normal or eGFR at least 50 mL/min/1.73m2
- ECOG performance status 0-1
- Absolute neutrophil count at least 1000/microL, platelets at least 50,000/microL, hemoglobin at least 8 g/dL
- Serum ALT and AST less than or equal to 3 times institutional upper limit unless liver involvement is present
- Negative blood tests for hepatitis B DNA and hepatitis C RNA
- Cardiac ejection fraction at least 50% without significant pericardial effusion
- No active infections including hepatitis B or C
- Ability and willingness to sign informed consent and undergo mandatory biopsies
- Willingness to use contraception or abstinence during and for 12 months after treatment
- Oxygen saturation on room air at least 92%
You will not qualify if you...
- Prior CAR T-cell therapy
- Use of any other investigational agents
- Live-attenuated or viral vector-based vaccine within 60 days before rituximab or planned within 100 days after CAR T infusion
- Urgent need for therapy due to tumor mass effects or spinal cord compression
- Active HIV infection
- Other second malignancies requiring recent treatment or not in remission except certain skin and breast cancers
- Positive pregnancy test in women of childbearing potential
- Active uncontrolled systemic infections requiring intravenous antibiotics
- Significant uncontrolled medical illnesses including cardiac, respiratory, renal, autoimmune, or neurologic disorders
- Primary immunodeficiencies not cured by prior stem cell transplant
- Recent use of systemic corticosteroids or immunosuppressive drugs above defined doses
- History of severe allergic reactions to study agents
- CNS disease involvement or active CNS lymphoma
- Recent checkpoint inhibitor therapy within 180 days
- Known active alcohol or drug abuse
- Active tumor lysis syndrome, rhabdomyolysis, or diabetic ketoacidosis
- Prior allogeneic stem cell transplant with more than mild graft-versus-host disease
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
J
Jennifer A Mann, C.R.N.P.
CONTACT
J
James N Kochenderfer, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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