Actively Recruiting
Metabolically Fit CD19 CAR T-cell Therapy With CD34 Selection in Patients With CD19+ Relapsed/Refractory NHL, CLL/SLL
Led by Medical University of South Carolina · Updated on 2026-03-27
27
Participants Needed
1
Research Sites
164 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-center, nonrandomized, open-label dose-escalation study followed by dose-expansion of CD19- CD34t metabolically programmed CAR T-cell therapy in adult patients with relapsed or refractory CD19 B-cell non-Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
CONDITIONS
Official 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...
- Histologic confirmation of CD19+ aggressive or indolent non-Hodgkin lymphoma, mantle cell lymphoma, or chronic lymphocytic leukemia/small lymphocytic lymphoma
- Relapsed or refractory disease after specified lines of systemic therapy depending on lymphoma subtype
- At least 18 years old
- ECOG performance status 0-2
- Adequate caregiving support for CAR T-cell therapy
- Measurable disease on imaging or bone marrow involvement for CLL
- If prior CD19 therapy received, biopsy showing CD19 expression
- Adequate organ function including bone marrow, liver, heart, lungs, and kidneys
- Controlled hepatitis B, hepatitis C, and HIV infections with suppressed viral loads
- Use of effective birth control for men and women of childbearing potential
- Ability to understand and voluntarily sign informed consent
You will not qualify if you...
- Pregnant or breast-feeding women
- Active central nervous system lymphoma
- Significant graft versus host disease requiring systemic immunosuppression
- Uncontrolled systemic infections
- Recent stroke or intracranial hemorrhage within 6 months
- History of other malignancy unless disease-free for over 1 year with exceptions
- Primary immunodeficiency or autoimmune disease requiring recent systemic immunosuppression
- Receipt of live vaccine within 28 days prior to registration
- Recent stem cell transplant or CAR T-cell therapy within specified timeframes
- Severe immediate hypersensitivity reaction to study agents
- Other illnesses deemed exclusionary by the investigator
- Unstable heart conditions or severe heart failure
- Evidence of active CNS lymphoma involvement unless in documented remission for at least 60 days
AI-Screening
AI-Powered Screening
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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
CONTACT
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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