Actively Recruiting
A Phase 1b Dose Escalation Study of Metabolically Fit CD19 CAR T Cells With CD34 Selection Markers in Adults With Relapsed or Refractory CD19 B-Cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia
Led by Medical University of South Carolina · Updated on 2026-03-27
27
Participants Needed
1
Research Sites
7 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new metabolically programmed CD19 CAR T-cell therapy with a CD34 selection marker in adults with relapsed or refractory CD19 B-cell non-Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). This study aims to improve safety, reduce relapse, and enhance the persistence and anti-tumor activity of CAR T-cells by creating a purified, high-quality product using metabolic programming and CD34 selection. The trial is a phase 1b, open-label, nonrandomized study conducted at a single center. Participants receive a dose-escalation of the CD19-CD34t metabolically programmed CAR T-cells infused intravenously in three dose levels ranging from 1 x 10^6 to 2 x 10^6 transduced T cells per kg of body weight. Before CAR T-cell infusion, patients undergo lymphodepleting chemotherapy with cyclophosphamide and fludarabine administered intravenously on days -5, -4, and -3. The infusion of CAR T-cells is done over 30 minutes or less using nonfiltered tubing to prevent cell clumping. The study will assess safety, dose limits, and optimal dosing over 12 months and up to 24 months for longer-term outcomes. During the study, participants will be closely monitored through clinical evaluations, imaging scans such as PET-CT or CT to measure disease, laboratory tests, and assessments of side effects including cytokine release syndrome and neurotoxicity. The primary outcomes include determining the maximum tolerated and recommended doses, as well as safety events up to 24 months. Secondary measures include response rates, survival, and duration of response. Participants must have adequate caregiver support and will be followed regularly to assess treatment effects and side effects throughout the study period, which may last up to two years.
CONDITIONS
Brief Title
Metabolically Fit CD19 CAR T-cell Therapy With CD34 Selection in Patients With CD19+ Relapsed/Refractory NHL, CLL/SLL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologic confirmation of CD19+ aggressive or indolent non-Hodgkin lymphoma subtypes, mantle cell lymphoma, or chronic lymphocytic leukemia/small lymphocytic lymphoma
- Relapsed or refractory disease after specified prior therapies based on lymphoma subtype
- Performance status of 0 to 2 on the ECOG scale
- Adequate caregiver support for CAR T-cell therapy
- Measurable disease by imaging or bone marrow biopsy
- Adequate organ function as defined by blood counts, liver, kidney, heart, and lung function within 14 days prior to registration
- For prior CD19 targeted therapy recipients, biopsy confirming sufficient CD19 expression
- Controlled hepatitis B, hepatitis C, and HIV infections under specified conditions
- Women of childbearing potential with negative pregnancy test and use of effective contraception
- Men and female partners of childbearing potential must use effective contraception
- Ability to understand and voluntarily sign informed consent
You will not qualify if you...
- Pregnant or breast-feeding women
- Active central nervous system lymphoma or recent CNS involvement without remission
- Significant graft versus host disease requiring systemic immunosuppression
- Uncontrolled systemic infections despite treatment
- Recent stroke, intracranial hemorrhage, or CNS disorders interfering with neurotoxicity evaluation
- History of malignancy other than lymphoma unless disease-free for over 1 year, with some exceptions
- Primary immunodeficiency or autoimmune disease requiring recent systemic immunosuppression
- Receipt of live vaccine within 28 days prior to registration
- Recent autologous or allogeneic stem cell transplant or CAR T-cell therapy within defined timeframes
- History of severe immediate allergic reactions to study agents
- Other illnesses deemed exclusionary by the investigator
- Unstable angina, recent myocardial infarction, or severe heart failure symptoms
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 receive chemotherapy with cyclophosphamide and fludarabine, followed by infusion of metabolically programmed CD19 CAR T-cells selected for CD34 expression.
Multiple visits over approximately 1 week including chemotherapy days and CAR T-cell infusion
Duration - Up to 24 months
Participants are monitored for safety, response to therapy, and long-term outcomes including occurrence of cytokine release syndrome and neurotoxicity.
Regular visits for up to 24 months
Trial Site Locations
Total: 1 location
1
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
H
HCC Clinical Trials Office
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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