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Taking people in United StatesPhase 1

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.

Key facts

Who runs it
Autolus Limited
Where
Atlanta, Aurora, Chicago, Cincinnati, Los Angeles, Palo Alto, Philadelphia, Salt Lake City, San Antonio, and Seattle, United StatesSee the 10 sitesAlso in 2 other countries, 5 sites
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)
Status
Recruiting
Phase
Phase 1
People taking part
30 people, planned
Started
16 Nov 2023
Expected to end
Nov 2027
Type of study
Interventional
Treatments tested
  • AUTO1
Record updated
13 November 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • < 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

Who cannot take part

  • 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

Check if you might fit

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?

Where in United States

Also in 2 other countries, 5 sites

  • Arthur M Blank HospitalAtlanta, United StatesContact: Autolus LtdTaking people
  • Children's Hospital ColoradoAurora, United StatesContact: Autolus LtdTaking people
  • Lurie Children's HospitalChicago, United StatesContact: Autolus LtdTaking people
  • Cincinnati Children's HospitalCincinnati, United StatesContact: Autolus LtdTaking people
  • Children's Hospital Los AngelesLos Angeles, United StatesContact: Autolus LtdTaking people
  • Lucile Packard Children's Hospital Stanford UniversityPalo Alto, United StatesContact: Autolus LtdTaking people
  • Children's Hospital of PhiladelphiaPhiladelphia, United StatesContact: Autolus LtdTaking people
  • Primary Children's HospitalSalt Lake City, United StatesContact: Autolus LtdTaking people
  • Methodist Children's HospitalSan Antonio, United StatesContact: Autolus LtdTaking people
  • Seattle Children's HospitalSeattle, United StatesContact: Autolus LtdTaking people

About the trial

What the trial wants to find out

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).

The group in the trial

  • AUTO1Treatment being tested

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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).
Plain-language title
Tests CD19 CAR T cell therapy in children with relapsed blood cancersGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT06173518, who can take part
Publications
Record updated
13 November 2026