Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT04545762

Anti-CD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma

Led by C. Babis Andreadis · Updated on 2026-01-14

36

Participants Needed

1

Research Sites

320 weeks

Total Duration

On this page

Sponsors

C

C. Babis Andreadis

Lead Sponsor

U

University of California, Davis

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study will assess safety and feasibility of infusing genetically modified autologous T cells transduced to express a chimeric antigen receptor targeting the B cell surface antigen Cluster of Differentiation 19 (CD19).

CONDITIONS

Official Title

Anti-CD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of relapsed or refractory Burkitt lymphoma with prior exposure to anti-CD20 antibody and anthracycline, and no significant circulating disease
  • Diagnosis of relapsed or refractory marginal zone lymphoma or lymphoplasmacytic lymphoma/Waldenström macroglobulinemia with at least 2 prior lines of chemoimmunotherapy including anti-CD20 antibody and alkylating agent
  • Measurable disease confirmed by PET-positive disease or serum monoclonal IgM > 0.5 g/dL
  • Symptomatic disease requiring systemic treatment for indolent lymphomas
  • CD19-positive by immunohistochemistry or flow cytometry on biopsy
  • Age 18 years or older at consent
  • Absolute lymphocyte count > 100/μL
  • ECOG performance status less than 2
  • Adequate organ function including bone marrow, liver, kidney, and cardiac function
  • Adequate vascular access for leukapheresis
  • Women of childbearing potential with negative pregnancy test and agreement to use contraception for 1 year post-treatment
  • Males with partners of childbearing potential agree to use barrier contraception
  • Ability to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • Prior autologous transplant within 6 weeks of planned CAR-T infusion
  • Prior CD19-targeted CAR-T cell therapy outside this protocol
  • Active malignancy other than non-melanoma skin cancer or carcinoma in situ
  • HIV seropositivity
  • Active hepatitis B or C infection with positive PCR
  • Uncontrolled illness including active infection, heart failure, unstable angina, arrhythmia, pulmonary abnormalities, or psychiatric/social issues limiting compliance
  • Pregnant or breastfeeding women
  • History of significant central nervous system disorders such as epilepsy, seizure disorders, paresis, aphasia, cerebrovascular disease, severe brain injury, dementia, Parkinson's disease
  • Autoimmune disease requiring immunosuppressive medication within 6 months
  • Body weight less than 40 kilograms

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

University of California, San Francisco

San Francisco, California, United States, 94143

Actively Recruiting

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Research Team

U

UCSF HDFCCC Cancer Immunotherapy Program

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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