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Looking for participantsPhase1

CARPALL: Immunotherapy With CD19+CD22 CAR T-cells for CD19+ and CD22+ Acute Lymphoblastic Leukaemia

Sponsor: University College, London

NCT ID: NCT02443831

View on ClinicalTrials.gov ↗

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.

Acute Lymphoblastic Leukemia

How this trial compares with your answers

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What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
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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

CD19CD22CD19 negativeCD22 negative

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
Inclusion Criteria: 1. Children and young adults (age 24 years or younger) with high risk/relapsed CD19+ and CD22+ acute lymphoblastic leukaemia with: 1. Resistant disease (\>5% blasts) at end of ALLTogether-1 protocol or equivalent induction 2. ALL with persisting high level MRD at 2nd time point of frontline national protocol (currently MRD \>10-4 at week 9 ALLTogether-1 Protocol or equivalent). 3. High risk infant ALL (age \< 6 months at diagnosis with MLL gene rearrangement and either presenting white cell count \> 300 x 10\^9/L or poor steroid early response (i.e. circulating blast count \>1x10\^9/L following 7 day steroid pre-phase of induction as per national guidelines or equivalent) 4. Any patient with t(17,19) TCF3-HLF rearrangement 5. High risk 1st relapse (defined as very early (relapse within 18 months of diagnosis) and early relapses (any patient relapsing on therapy or within 6 months of completing treatment) and any relapse with high risk genetics, namely (KMT2A (MLL) rearrangements, low hypodiploidy/near haploidy, t(17;19)(q22;p13)/TCF3-HLF, iAMP21 and t(1;19)(q21;p13)/TCF3- PBX1, t(9;22)(34.1 q11.2)/BCR-ABL1 6. Any on therapy relapse in patients age 16-24 7. Any relapse of infant ALL 8. ALL post ≥ 2nd relapse 9. Any refractory relapse of ALL (defined as \> 1% blasts by flow cytometry after a at least 1 cycle of standard chemotherapy) 10. ALL with MRD \>10-4 prior to planned stem cell transplant 11. Any relapse of ALL eligible for stem cell transplant but no available HLA matched donor or other contraindication to transplant 12. Any relapse of ALL after stem cell transplant as long as planned time of CD19+CD22CAR T cell infusion is \> 4 months post-transplant 13. Early (defined as \< 6 months post-infusion) loss of B cell aplasia or any CD19+CD22+ relapse following CD19CAR T cell therapy with Tisagenlecleucel Note patients with isolated CNS relapse meeting one or more of the criteria above are eligible for the study 2. Agreement to have a pregnancy test, use adequate contraception (if applicable) 3. Written informed consent Exclusion Criteria: Exclusion Criteria for registration: 1. Active Hepatitis B, C or HIV infection 2. Oxygen saturation ≤ 90% on air 3. Bilirubin \> 3 x upper limit of normal 4. Creatinine \> 3 x upper limit of normal 5. Women who are pregnant or breastfeeding 6. Stem Cell Transplant patients only: active significant (overall Grade ≥ II, Seattle criteria) acute GVHD or moderate/ severe chronic GVHD (NIH consensus criteria) requiring systemic steroids. 7. Inability to tolerate leucapheresis 8. Karnofsky (age ≥ 10 years) or Lansky (age \< 10) score ≤ 50% 9. Pre-existing significant neurological disorder (other than CNS involvement of underlying haematological malignancy) 10. CD19 negative or CD22 negative disease Exclusion criteria for CD19+CD22CAR T-cell infusion: 1. Severe intercurrent infection at the time of scheduled CD19+CD22 CAR T-cell infusion 2. Requirement for supplementary oxygen or active pulmonary infiltrates at the time of scheduled CD19+CD22 CAR T-cell infusion 3. Allogeneic transplant recipients with active significant acute GVHD overall grade ≥II or moderate/severe chronic GVHD requiring systemic steroids at the time of scheduled CD19+CD22 CAR T-cell infusion. Note: Such patients will be excluded until the patient is GVHD free and off steroids

Where Is This Study? (3 UK sites)

Great Ormond Street Hospital

London, United Kingdom

Recruiting
Hospital R&D contact (matched)

Main Email: Research.Governance@gosh.nhs.uk

Research.Governance@gosh.nhs.uk0207 905 2700

University College Hospital

London, United Kingdom

Recruiting
Hospital R&D contact (matched)

Rajinder Sidhu - Associate Director, Research Governance and Operations

uclh.jro-communications@nhs.net020 3447 9825

Manchester Royal Children's Hospital

Manchester, United Kingdom

Recruiting
Hospital R&D contact (matched)

Elizabeth Mainwaring

R&D.applications@mft.nhs.uk0161 276 3340

How to Get in Touch

Aniqa Tasnim

Sponsor contact

CONTACT

0203 108 4753 ctc.carpall@ucl.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-02