Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT05702853

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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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

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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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