Clinical Trials Directory

Trials / Recruiting

RecruitingNCT05098613

Preliminary Safety and Tolerability of CD19x22 CAR T Cells in Adolescent and Adult R/R B-NHL Patients

Phase 1 Study of Bispecific CD19 and CD22 Chimeric Antigen Receptor Co-Expressing T Cells (CD19x22 CAR T) in Adolescent and Adult Patients With Relapsed and/or Refractory B-Non-Hodgkin's Lymphoma (B-NHL)

Status
Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
68 (estimated)
Sponsor
University of Colorado, Denver · Academic / Other
Sex
All
Age
16 Years
Healthy volunteers
Not accepted

Summary

This open-label, single arm phase 1 trial aims to determine the safety and tolerability of anti-CD19 and anti-CD22 chimeric antigen receptor-expressing (CAR) T cells (CD19x22 CAR T) in adolescents and adults with relapsed/refractory (R/R) B-cell Non-Hodgkin Lymphoma (B-NHL). This trial will determine the maximum tolerated dose of CD19x22 CAR T cells using a standard 3+3 trial design.

Detailed description

To determine the safety and tolerability of infusing CD19x22 CAR T, generated using a bicistronic vector, in adolescents and adults with R/R B-NHL, and to determine the recommended Phase II dose (RP2D). Secondary objectives for all subjects include: 1) Feasibility of manufacturing and infusion, 2) Safety of infusion and 3) Efficacy: Descriptive characterization of complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) at Day +90. As well, progression-free survival (PFS), overall survival (OS), duration of remission (DOR) and overall response rate (ORR) will be determined at 1 year. Efficacy will be descriptively stratified based on prior receipt of CAR-T cell therapy.

Conditions

Interventions

TypeNameDescription
DRUGCD19x22 CAR T CellsAutologous peripheral blood mononuclear cells transduced with CD19x22 CAR T lentiviral vector.

Timeline

Start date
2021-12-21
Primary completion
2026-12-01
Completion
2027-12-01
First posted
2021-10-28
Last updated
2025-12-24

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT05098613. Inclusion in this directory is not an endorsement.