NCT04545762

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

A Phase 1 Clinical Trial of Anti-CD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: C. Babis Andreadis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

This is an open-label, pilot, phase 1 study to determine the safety profile of anti-CD19 CAR-T cell infusion in participants with R/R B-cell NHL. PRIMARY OBJECTIVES 1. To evaluate the safety of administering chimeric antigen receptor T cells targeting CD-19 to patients with relapsed or refractory CD19+ B-cell non-Hodgkin lymphoma (NHL). 2. To determine the recommended phase 2 dose (RP2D) for this cellular therapy. SECONDARY OBJECTIVES 1. To assess the safety and toxicity of cell collection and infusion of CAR-T cells targeting CD19 in patients with relapsed or refractory CD19+ B cell NHL. 2. To describe the efficacy of chimeric antigen receptor T cells targeting CD-19 in patients with relapsed or refractory CD19+ B cell NHL. 3. To evaluate the feasibility of CD19 CAR T cell manufacturing for patients with relapsed or refractory CD19+ B cell NHL of local manufacturing and ability to produce adequate quantities of vector positive T-cells. OUTLINE Participants will be enrolled to either the dose escalation or dose expansion cohorts. Dose Escalation: CLOSED TO ENROLLMENT Dose Expansion: The dose expansion phase of the study will be limited to two disease-specific cohorts: * Cohort B: Participants with Burkitt lymphoma (B). * Cohort M/W: Participants with Marginal Zone Lymphoma (MZL) and Waldenström Macroglobulinemia (WM). Participants will receive an infusion of Anti-CD19 CAR-T cells during the main study and will be followed for 12 months before being transferred into long term follow-up during years 1 to 15.

Conditions

• Refractory Non-Hodgkin Lymphoma
• Burkitt Lymphoma
• Mantle Cell Lymphoma
• Follicular Lymphoma
• Lymphoplasmacytic Lymphoma
• Primary Mediastinal Large B Cell Lymphoma
• Diffuse Large B Cell Lymphoma
• Small Lymphocytic Lymphoma
• Transformed Lymphoma
• Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Fludarabine	Given intravenously (IV)
DRUG	Cyclophosphamide	Given intravenously (IV)
BIOLOGICAL	anti-CD19 CAR-T cells	Single infusion

Timeline

• Start date: 2020-09-11
• Primary completion: 2026-10-31
• Completion: 2026-10-31
• First posted: 2020-09-11
• Last updated: 2026-01-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study