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Looking for participantsPhase1

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

NCT ID: NCT06173518

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
AUTO1 (biological)
How long the study runs
Study runs about 48 months (dates as stated)
About the drug or intervention
AUTO1 — biological: Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with anti-CD19 chimeric antigen receptor (CAR) T cells
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
0 Years to 18 Years
Who
All
Number of participants
30
Started
2023-11-16
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for relapsed or refractory b cell acute lymphoblastic leukemia
  • • Phase1 - 30 participants
  • • 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)

Who can take part?

  • • Ages 0 Years to 18 Years
  • • Diagnosed with relapsed or refractory b cell acute lymphoblastic leukemia

Where?

  • • London - Great Ormond Street Hospital for Children NHS Foundation Trust
  • • Manchester - Royal Manchester Children's Hospital
  • • Newcastle upon Tyne - Great North Children's Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

More detail

This is a single-arm, open-label, multi-center, Phase 1b/2 study to determine the safety and efficacy of obe-cel administered intravenously in pediatric patients \< 18 years old with r/r B ALL and with r/r aggressive mature B NHL. The safety and tolerability of obe cel in pediatric patients will be continually monitored by the Sponsor. Efficacy endpoints will be determined by an Independent Response Review Committee (IRRC). The study will involve consented patients going through the following sequential study periods: screening, leukapheresis, bridging as necessary, lymphodepletion, treatment evaluation, and follow-up.

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

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 0 Years - 18 Years
  • Who can join: All genders

Biomarkers mentioned

CD19

What the study is looking for

  • ✓\< 18 years old at screening
  • ✓≥ 6 kg body weight at screening
  • ✓Pediatric patients with r/r B ALL
  • ✓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,...

Who cannot take part

  • ✗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...
  • ✗Received prior (\< 3 months before obe cel infusion) stem cell transplantation.
  • ✗Prior CD19 treatment that targets specific changes in the cancer other than blinatumomab.
See the full criteria
INCLUSION CRITERIA: * \< 18 years old at screening * ≥ 6 kg body weight at screening Pediatric patients with r/r B ALL r/r CD19-positive aggressive mature B including the B NHL subtypes: i) diffuse large B cell lymphoma, ii) Burkitt's lymphoma, iii) primary mediastinal large B cell lymphoma, iv) high-grade B cell lymphoma (not otherwise specified). * 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 CRITERIA: * 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.

Where Is This Study? (3 UK sites)

Great Ormond Street Hospital for Children NHS Foundation Trust

London, United Kingdom

Recruiting
Hospital R&D contact (matched)

Main Email: Research.Governance@gosh.nhs.uk

Research.Governance@gosh.nhs.uk0207 905 2700

Royal Manchester Children's Hospital

Manchester, United Kingdom

Recruiting
Hospital R&D contact (matched)

Elizabeth Mainwaring

R&D.applications@mft.nhs.uk0161 276 3340

Great North Children's Hospital

Newcastle upon Tyne, United Kingdom

Recruiting

How to Get in Touch

Autolus Ltd

Sponsor contact

CONTACT

+44 (0) 203 911 4385 clinicaltrials@autolus.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10