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
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?
Trial 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.