A Phase I/II Study to Evaluate the Safety of Cellular Immunotherapy Using Autologous T Cells Engineered to Express a CD20-Specific Chimeric Antigen Receptor for Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphomas

NCT03277729 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2026-01-05

Study results available
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Summary

The purpose of this research is to find the best dose of genetically modified T-cells, to study the safety of this treatment, and to see how well it works in treating patients with B cell non-Hodgkin lymphoma that has come back (relapsed) or did not respond to previous treatment (refractory).

Conditions

  • Recurrent B-Cell Non-Hodgkin Lymphoma
  • Recurrent Chronic Lymphocytic Leukemia
  • Recurrent Diffuse Large B-Cell Lymphoma
  • Recurrent Follicular Lymphoma
  • Recurrent Lymphoplasmacytic Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Refractory B-Cell Non-Hodgkin Lymphoma
  • Refractory Diffuse Large B-Cell Lymphoma
  • Refractory Follicular Lymphoma
  • Refractory Lymphoplasmacytic Lymphoma
  • Refractory Mantle Cell Lymphoma
  • Refractory Transformed Non-Hodgkin Lymphoma
  • Recurrent Transformed B-Cell Non-Hodgkin Lymphoma
  • Recurrent Transformed Chronic Lymphocytic Leukemia
  • Refractory Marginal Zone Lymphoma
  • Refractory Transformed B-Cell Non-Hodgkin Lymphoma
  • Refractory Transformed Chronic Lymphocytic Leukemia
  • Recurrent Small Lymphocytic Lymphoma
  • Refractory Chronic Lymphocytic Leukemia
  • Refractory Small Lymphocytic Lymphoma
  • Recurrent Central Nervous System Lymphoma
  • Refractory Central Nervous System Lymphoma

Interventions

BIOLOGICAL

Chimeric Antigen Receptor T-Cell Therapy

Given CD20 CAR T cell IV

DRUG

Cyclophosphamide

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

PROCEDURE

Leukapheresis

Undergo leukapheresis

DRUG

Fludarabine Phosphate

Given IV

Sponsors & Collaborators

  • Mustang Bio

    collaborator INDUSTRY
  • Fred Hutchinson Cancer Center

    lead OTHER

Principal Investigators

  • Mazyar Shadman · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-05
Primary Completion
2024-03-29
Completion
2039-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03277729 on ClinicalTrials.gov