Actively Recruiting
Phase I/II Trial of Anti-CD19 Chimeric Antigen Receptor T-Cell Immunotherapy for B-cell Leukemias
Led by National Cancer Institute (NCI) · Updated on 2026-05-04
132
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a novel anti-CD19 chimeric antigen receptor (CAR) T-cell therapy for adults with advanced blood cancers, including chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and B-cell acute lymphoblastic leukemia or lymphoma (ALL). This phase I/II trial aims to assess the safety and overall response rate of this gene-modified T-cell treatment, which targets the CD19 protein found on cancer cells. The study includes participants with cancers resistant to standard treatments, seeking improved options for these challenging diseases. Participants receive a combination of treatments beginning with two doses of rituximab and a chemotherapy conditioning regimen consisting of cyclophosphamide and fludarabine to reduce leukemia cells. Then, their own T cells are collected via leukapheresis and genetically modified to attack CD19-expressing cancer cells. After a 3-day preparation with chemotherapy drugs, the modified CAR T cells are infused back into the bloodstream. The trial uses dose escalation to find the optimal CAR T-cell dose, followed by a mandatory 9-day hospital stay for monitoring. Dose expansion cohorts further evaluate the therapy at the determined dose. Throughout the study, participants undergo screening including imaging and heart function tests, and mandatory biopsies to confirm CD19 expression. Follow-up visits occur frequently in the first year post-infusion and then less often, with long-term gene therapy monitoring continuing up to 15 years. Researchers measure treatment safety, overall response rates, duration of response, and adverse events. Careful monitoring aims to detect toxicities such as fever, neurological effects, or elimination of normal B cells. The total follow-up period ensures detailed assessment of long-term outcomes and safety.
CONDITIONS
Brief Title
Anti-CD19 Chimeric Antigen Receptor T-Cell Immunotherapy for Leukemias
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or B-cell acute lymphoblastic leukemia or lymphoma (ALL)
- Cancer cells must uniformly express CD19 and at least 20% must express CD20
- Measurable malignancy by CT scan or flow cytometry of bone marrow or blood
- At least 14 days since last systemic therapy, except certain kinase inhibitors which may be continued
- ECOG performance status 0-1
- Adequate organ and marrow function, including specific blood counts and liver and kidney function
- Cardiac ejection fraction of 50% or greater with no significant pericardial effusion
- Negative tests for hepatitis B and C
- Ability to understand and sign informed consent
- Willingness to undergo mandatory biopsies during the study
- Women of childbearing potential must use effective contraception and agree not to donate eggs for 12 months after treatment
- Breastfeeding participants must stop breastfeeding from treatment start through 12 months after last dose
You will not qualify if you...
- Receiving other investigational agents
- Prior CAR T-cell therapy
- Live-attenuated or viral vector-based vaccine within 60 days before treatment or planned within 100 days after
- Need for urgent therapy due to tumor mass effects or spinal cord compression
- Active HIV infection
- Second malignancies requiring recent treatment or not in complete remission, except certain skin cancers and treated breast cancer
- Positive pregnancy test in women of childbearing potential
- Active uncontrolled infections requiring recent intravenous antibiotics
- Active coagulation disorders or major uncontrolled medical illnesses
- Significant neurologic disorders not fully resolved
- Primary immunodeficiency not cured by prior stem cell transplant
- Recent systemic corticosteroid use above specified doses
- Severe hypersensitivity to study agents
- CNS involvement by lymphoma or leukemia
- Recent checkpoint inhibitor therapy within 180 days
- Active alcohol or drug abuse
- History of allergy to study drug components
- Active tumor lysis syndrome or rhabdomyolysis
- Active diabetic ketoacidosis or hyperosmolar hyperglycemic state
- For prior allogeneic stem cell transplant recipients, presence of active or severe graft-versus-host disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 week
Participants undergo leukapheresis to collect T cells, followed by two doses of rituximab and a 3-day chemotherapy conditioning regimen with cyclophosphamide and fludarabine to prepare for CAR T-cell infusion.
Multiple visits over 1 week including rituximab infusions and chemotherapy on days -5 to -3
Duration - 9 days
Participants receive an infusion of genetically modified CAR T cells. Following infusion, participants stay hospitalized for 9 days to monitor for potential toxicities and side effects.
Continuous inpatient stay for 9 days
Duration - Up to 1 year with less frequent visits thereafter
Participants attend outpatient visits for monitoring and assessment of treatment response and safety at scheduled intervals after CAR T-cell infusion.
Visits at 2 weeks and 1, 2, 3, 4, 6, 9, and 12 months post-infusion
Duration - Up to 15 years
Participants are monitored long-term for up to 15 years after CAR T-cell infusion to assess safety and long-term outcomes.
Periodic visits as scheduled for long-term follow-up
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.
J
James N Kochenderfer, M.D.
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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