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

Recruiting now · Phase 1

Conditions studied: Acute Lymphoblastic Leukemia

In brief

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

Key facts

Study ID

NCT02443831

Run by

University College, London

People needed

50

Starts

2016-04-01

Expected to finish

2041-12-31

Last updated by the study team

2026-05-22

Who can join

Age: any, up to 24. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children and young adults (age 24 years or younger) with high risk/relapsed CD19+ and CD22+ acute lymphoblastic leukaemia with:
• 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 ALLTogether-1 Protocol or equivalent).
• 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)
• Any patient with t(17,19) TCF3-HLF rearrangement
• 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
• Any on therapy relapse in patients age 16-24
• Any relapse of infant ALL
• ALL post ≥ 2nd relapse
• Any refractory relapse of ALL (defined as > 1% blasts by flow cytometry after a at least 1 cycle of standard chemotherapy)
• ALL with MRD >10-4 prior to planned stem cell transplant
• Any relapse of ALL eligible for stem cell transplant but no available HLA matched donor or other contraindication to transplant
• Any relapse of ALL after stem cell transplant as long as planned time of CD19+CD22CAR T cell infusion is > 4 months post-transplant
• 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
• Agreement to have a pregnancy test, use adequate contraception (if applicable)
• Written informed consent

You may not qualify if…

• Exclusion Criteria for registration:
• Active Hepatitis B, C or HIV infection
• Oxygen saturation ≤ 90% on air
• Bilirubin > 3 x upper limit of normal
• Creatinine > 3 x upper limit of normal
• Women who are pregnant or breastfeeding
• 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.
• Inability to tolerate leucapheresis
• Karnofsky (age ≥ 10 years) or Lansky (age < 10) score ≤ 50%
• Pre-existing significant neurological disorder (other than CNS involvement of underlying haematological malignancy)
• CD19 negative or CD22 negative disease
• Exclusion criteria for CD19+CD22CAR T-cell infusion:
• Severe intercurrent infection at the time of scheduled CD19+CD22 CAR T-cell infusion
• Requirement for supplementary oxygen or active pulmonary infiltrates at the time of scheduled CD19+CD22 CAR T-cell infusion
• 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 it is running

• Great Ormond Street Hospital — London, United Kingdom (enrolling)
• University College Hospital — London, United Kingdom (enrolling)
• Manchester Royal Children's Hospital — Manchester, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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