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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
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
Where Is This Study? (3 UK sites)
Great Ormond Street Hospital for Children NHS Foundation Trust
London, United Kingdom
Main Email: Research.Governance@gosh.nhs.uk
Research.Governance@gosh.nhs.uk0207 905 2700Royal Manchester Children's Hospital
Manchester, United Kingdom
Great North Children's Hospital
Newcastle upon Tyne, United Kingdom
How to Get in Touch
Autolus Ltd
Sponsor contactCONTACT
