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A Study of CD19 Targeted CAR T Cell Therapy for Pediatric Leukemia and Lymphoma

This study is testing a treatment called AUTO1 (also known as obe-cel) in children and teenagers (ages 0-18) with B-cell acute lymphoblastic leukemia (B ALL) or B-cell non-Hodgkin lymphoma (B NHL) that has come back or not responded to previous treatments. AUTO1 is a type of CAR T-cell therapy, which uses your own immune cells, specially modified to find and fight cancer cells. Before receiving AUTO1, patients will have chemotherapy. The study aims to see how safe AUTO1 is by tracking side effects, and how well it works by measuring if patients achieve complete remission (cancer free) within 3 months. About 30 patients are expected to join.

Study design
This is a Phase 1b/2 study, meaning it's an early-stage trial looking at safety and effectiveness. It's a single-arm study, so all participants receive the same treatment, and it's open-label, meaning everyone knows what treatment is being given.
What's involved
Participants will go through several steps including screening, collecting immune cells (leukapheresis), chemotherapy, receiving the AUTO1 treatment, and then regular check-ups to evaluate the treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for side effects and severe hypogammaglobulinemia (a condition affecting the immune system) for up to 24 months after treatment.

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NCT06173518

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)

Recruiting
PHASE1Ages 0–18InterventionalTreatment
Autolus Limited
~30 participants
Updated 2026-03-02 on ClinicalTrials.gov
What's tested:AUTO1

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency and severity of adverse events (AEs) and serious adverse events (SAEs)
Measured over Up to 24 months
+2 more outcomes measured

Conditions

Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia
Relapsed or Refractory B Cell Non-Hodgkin Lymphoma

Explore related trials

B Acute Lymphoblastic LeukemiaBurkitt LymphomaDiffuse Large B-Cell LymphomaHematologic NeoplasmHigh Grade B-Cell LymphomaPrimary Mediastinal Large B-Cell LymphomaCD19 Gene

Where it's being run

8 sites across 5 states
United Kingdom3
Spain2
Pennsylvania1
Texas1
Utah1

Who to contact

Autolus Ltd
[email protected]
+44 (0) 203 911 4385
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

\< 18 years old at screening
≥ 6 kg body weight at screening
Karnofsky (age ≥ 10 years) or Lansky (age \< 10 year) performance status score ≥ 50%.
In participants with B ALL, local documentation of CD19 expression on leukemic blasts in the BM, peripheral blood, or cerebrospinal fluid or biopsy done no more than 30 days prior to consent.
Adequate renal, hepatic, pulmonary, and cardiac function.

Exclusion

Diagnosis of chronic myelogenous leukemia in lymphoid blast crisis.
History or presence of clinically relevant central nervous system (CNS) pathology unrelated to CNS leukemia.
Presence of active or uncontrolled fungal, bacterial, viral, or other infection requiring systemic antimicrobials for management.
Received prior (\< 3 months before obe cel infusion) stem cell transplantation.
Prior CD19 targeted therapy other than blinatumomab.
Experienced Grade ≥ 3 neurotoxicity following blinatumomab.

What this trial measures

  • Frequency and severity of adverse events (AEs) and serious adverse events (SAEs)Up to 24 months
  • Incidence and duration of severe hypogammaglobulinemiaUp to 24 months
  • Proportion of pediatric participants with r/r B ALL at screening who achieve complete remission (CR) within 3 months of obe-cel infusion per Independent Response Review Committee (IRRC) assessment3 months