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
- Leukapheresis (procedure), Total Body Irradiation (TBI) (radiation), Lymphodepletion with Fludarabine (drug), Lymphodepletion with Cyclophosphamide (drug)
- How long the study runs
- Study runs about 308 months (dates as stated)
- About the drug or intervention
- Leukapheresis — procedure: Patients will undergo an unstimulated leukapheresis to isolate the required immune cells to produce the CD19+CD22 CAR T-cells · Total Body Irradiation (TBI) — radiation: Participants will receive low-dose total body irradiation delivered as a single fraction on day -7 prior to CD19+CD22CAR T-cell infusion. · Lymphodepletion with Fludarabine — drug: Patients will receive lymphodepleting chemotherapy with iv fludarabine on days -6 to -3 prior to CD19+CD22CAR T-cell infusion. · Lymphodepletion with Cyclophosphamide — drug: Patients will receive lymphodepleting chemotherapy with iv cyclophosphamide on days -6 to -5 prior to CD19+CD22CAR T-cell infusion. · CD19+CD22 CAR T-cells — biological: 1 dose of CD19+CD22 CAR T-cells given as an intravenous injection through a Hickman line or PICC line (peripherally inserted central catheter) on day 0.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- Up to 24 Years
- Who
- All
- Number of participants
- 50
- Started
- 2016-04
- Last checked
- 2026-02
Plain English Summary
What is this study?
- • Testing a new treatment for acute lymphoblastic leukemia
- • Phase1 - 50 participants
- • This study aims to evaluate the safety, efficacy and duration of response of CD19+CD22 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in children with high risk, relapsed CD19+ and CD22+ acute lymphoblastic leukaemia
Who can take part?
- • Ages Up to 24 Years
- • Diagnosed with acute lymphoblastic leukemia
Where?
- • London - Great Ormond Street Hospital
- • London - University College Hospital
- • Manchester - Manchester Royal Children's Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This study aims to evaluate the safety, efficacy and duration of response of CD19+CD22 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in children with high risk, relapsed CD19+ and CD22+ acute lymphoblastic leukaemia
More detail
This is a multi-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product named CD19+CD22 Chimeric Antigen Receptor (CAR) T-cells (CD19+CD22 CAR T-cells) in children and young adults (age \<24 years) with high risk, relapsed CD19+ and CD22+ acute lymphoblastic leukaemia. Following informed consent and registration to the trial, patients will undergo an unstimulated leukapheresis for the generation of the CD19+CD22 CAR T-cells. Patients will receive the CD19+CD22CAR T-cells following lymphodepleting chemotherapy and total body irradiation. The study will evaluate the safety, efficacy and duration of response of the CD19+CD22 CAR T-cells in children with high risk relapsed CD19+ and CD22+ acute lymphoblastic leukaemia.
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: Up to 24 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Children and young adults (age 24 years or younger) with high risk/relapsed CD19+ and CD22+ acute lymphoblastic...
- ✓Resistant disease (\>5% blasts) at end of ALLTogether-1 protocol or equivalent induction
- ✓ALL with persisting high level MRD at 2nd time point of frontline national protocol (currently MRD \>10-4 at week 9...
- ✓Any patient with t(17,19) TCF3-HLF rearrangement
- ✓Any on therapy relapse in patients age 16-24
Who cannot take part
- ✗Exclusion Criteria for registration:
- ✗Active Hepatitis B, C or HIV infection
- ✗Oxygen saturation ≤ 90% on air
- ✗liver blood test \> 3 x upper limit of normal
- ✗Creatinine \> 3 x upper limit of normal
See the full criteria
Where Is This Study? (3 UK sites)
Great Ormond Street Hospital
London, United Kingdom
Main Email: Research.Governance@gosh.nhs.uk
Research.Governance@gosh.nhs.uk0207 905 2700University College Hospital
London, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825Manchester Royal Children's Hospital
Manchester, United Kingdom
How to Get in Touch
Aniqa Tasnim
Sponsor contactCONTACT
