Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06173518
PHASE1

A Study of CD19 Targeted CAR T Cell Therapy in Pediatric Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia (B ALL) and Aggressive Mature B-cell Non-Hodgkin Lymphoma (B NHL)

Sponsor: Autolus Limited

View on ClinicalTrials.gov

Summary

This is a Phase 1b/2 study to evaluate the safety and efficacy of autologous T cells engineered with a chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 in pediatric patients with relapsed or refractory (r/r) B cell acute lymphoblastic leukemia (B ALL) and r/r B cell Non-Hodgkin lymphoma (B NHL).

Official title: A Single-Arm, Open-Label, Multicenter, Phase 1b/2 Study Evaluating the Safety and Efficacy of AUTO1 (Obecabtagene Autoleucel [Obe-cel]) in Pediatric Patients With CD19-positive Relapsed/Refractory (R/R) B Cell Acute Lymphoblastic Leukemia (B ALL) or R/R Aggressive Mature B Cell Non-Hodgkin Lymphoma (B NHL).

Key Details

Gender

All

Age Range

0 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2023-11-16

Completion Date

2027-11

Last Updated

2026-03-02

Healthy Volunteers

No

Interventions

BIOLOGICAL

AUTO1

Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with anti-CD19 chimeric antigen receptor (CAR) T cells

Locations (8)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Methodist Children's Hospital

San Antonio, Texas, United States

Primary Children's Hospital

Salt Lake City, Utah, United States

Hospital Vall d'Hebron

Barcelona, Spain

Hospital Nino Jesus

Madrid, Spain

Great Ormond Street Hospital for Children NHS Foundation Trust

London, United Kingdom

Royal Manchester Children's Hospital

Manchester, United Kingdom

Great North Children's Hospital

Newcastle upon Tyne, United Kingdom