Tests CD19 CAR T cell therapy in children with relapsed blood cancers
Tests AUTO1 cell therapy in children with relapsed or refractory B-cell leukemia or lymphoma.
Plain-language title generated from the registry record
Registry 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)
Key facts
- Where
- Barcelona and Madrid, SpainSee the 2 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children with B cell acute lymphoblastic leukemia or aggressive B cell non-Hodgkin lymphoma that came back or did not respond to treatment, and whose cancer cells carry CD19.
- Age
- Younger than 18 years.
- Sex
- All sexes can join.
- Disease stage
- Relapsed or refractory B cell acute lymphoblastic leukemia, or relapsed or refractory CD19-positive aggressive mature B cell non-Hodgkin lymphoma (diffuse large B cell lymphoma, Burkitt's lymphoma, primary mediastinal large B cell lymphoma, or high-grade B cell lymphoma, not otherwise specified).
- Earlier treatment
- A stem cell transplant less than 3 months before the obe cel infusion is not allowed. Earlier CD19 targeted therapy is not allowed, except blinatumomab.
- Biomarker or test result
- CD19-positive cancer. In B ALL, CD19 on leukemic blasts must be documented, with a test done no more than 30 days before consent.
Main reasons for not taking part
- Chronic myelogenous leukemia in lymphoid blast crisis
- Central nervous system disease not caused by leukemia
- Active or uncontrolled infection needing systemic antimicrobials
- Stem cell transplant less than 3 months before the obe cel infusion
- Grade 3 or higher neurotoxicity after blinatumomab
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 0 and 18 years old?
Source: NCT06173518, who can take part
Where in Spain
- Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
- Hospital Nino JesusMadrid, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Autolus Limited
- Trial code
- NCT06173518EU 2023-506307-26-00
- Record updated
- 9 October 2026
- Original description
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).Read full original descriptionShow less
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).
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).
Inclusion: < 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: Received prior (< 3 months before obe cel infusion) stem cell transplantation; Prior CD19 targeted therapy other than blinatumomab; Presence of active or uncontrolled fungal, bacterial, viral, or other infection requiring systemic antimicrobials for management; Diagnosis of chronic myelogenous leukemia in lymphoid blast crisis; History or presence of clinically relevant central nervous system (CNS) pathology unrelated to CNS leukemia; Experienced Grade ≥ 3 neurotoxicity following blinatumomab.