Actively Recruiting
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)
Led by Autolus Limited · Updated on 2026-03-02
30
Participants Needed
8
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Younger than 18 years old at screening
- Body weight of at least 6 kg at screening
- Pediatric patients with relapsed or refractory (r/r) B cell acute lymphoblastic leukemia (B ALL) or r/r CD19-positive aggressive mature B cell Non-Hodgkin lymphoma subtypes including diffuse large B cell lymphoma, Burkitt's lymphoma, primary mediastinal large B cell lymphoma, and high-grade B cell lymphoma (not otherwise specified)
- Karnofsky (for age 10 years or older) or Lansky (for younger than 10 years) performance status score of 50% or higher
- For B ALL patients, local documentation of CD19 expression on leukemic blasts in bone marrow, peripheral blood, cerebrospinal fluid, or biopsy within 30 days prior to consent
- Adequate kidney, liver, lung, and heart function
You will not qualify if you...
- Diagnosis of chronic myelogenous leukemia in lymphoid blast crisis
- History or presence of clinically relevant central nervous system (CNS) problems unrelated to CNS leukemia
- Active or uncontrolled fungal, bacterial, viral, or other infections needing systemic antimicrobial treatment
- Received stem cell transplantation less than 3 months before obe-cel infusion
- Prior CD19 targeted therapy other than blinatumomab
- Experienced Grade 3 or higher neurotoxicity after blinatumomab
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
2
Methodist Children's Hospital
San Antonio, Texas, United States, 78229
Actively Recruiting
3
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
Actively Recruiting
4
Hospital Vall d'Hebron
Barcelona, Spain
Actively Recruiting
5
Hospital Nino Jesus
Madrid, Spain
Actively Recruiting
6
Great Ormond Street Hospital for Children NHS Foundation Trust
London, United Kingdom
Actively Recruiting
7
Royal Manchester Children's Hospital
Manchester, United Kingdom
Actively Recruiting
8
Great North Children's Hospital
Newcastle upon Tyne, United Kingdom
Actively Recruiting
Research Team
A
Autolus Ltd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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