NCT07168486

CD19.20.22 CAR T-cells for Patients With Relapsed/Refractory B-Cell Lymphomas

A Phase Ia Study of Tri-specific CAR19.20.22 Chimeric Antigen Receptor (CAR) T-cells for Patients With Relapsed/Refractory B-Cell Lymphomas

• Status: Enrolling By Invitation
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to treat patients diagnosed with relapsed or refractory positive B cell lymphoma - positive for 2 or more target antigens - with CAR19.20.22 CAR T-cells. Based on the preclinical characteristics of the LTG2950, CAR19.20.22 tri-specific CAR T-cells the Investigators have developed the following hypotheses to be tested in our phase Ia clinical trial. The Investigators hypothesize that these novel CAR T-cells will show: * good safety and tolerability * a high degree of efficacy * very good persistence * an acceptable level of exhaustion

Detailed description

This is a phase 1a, open-label, single center study evaluating the safety and efficacy CAR19.20.22 in subjects with r/r B-cell malignancies. The study will comprise dose-escalation. The dose-escalation will use a modified 3+3 design. Up to 12 subjects will be enrolled and treated at the sequential dose-escalation levels and evaluated. Infusion of CAR19.20.22 will be staggered to allow observations of acute and subacute toxicities.

Conditions

• B-Cell Lymphoma
• Diffuse Large B Cell Lymphoma (DLBCL)
• Primary Mediastinal Large B-cell Lymphoma (PMBCL)
• Follicular Lymphoma
• Transformed Follicular Lymphoma (tFL)
• Mantle Cell Lymphoma
• Chronic Lymphocytic Leukemia
• Small Lymphocytic Lymphoma
• Richter Transformation
• Marginal Zone Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	CD19.20.22 CAR T cells	CAR19.20.22 is a type of immunotherapy known as a chimeric antigen receptor T-cells (CAR T-cells).
DRUG	Fludarabine and Cyclophosphamide	Lymphodepletion with Flu-Cy prior to CAR T cell therapy

Timeline

• Start date: 2024-10-28
• Primary completion: 2027-07-01
• Completion: 2028-07-01
• First posted: 2025-09-11
• Last updated: 2025-09-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study