RecruitingPhase 1NCT02443831

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

Immunotherapy With CD19+CD22 CAR Redirected T-cells for High Risk/Relapsed Paediatric CD19+ and CD22+ Acute Lymphoblastic Leukaemia


Sponsor

University College, London

Enrollment

50 participants

Start Date

Apr 1, 2016

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Max Age: 24 Years

Plain Language Summary

Simplified for easier understanding

This study (called CARPALL) is testing a new type of immune cell therapy — called CAR T-cell therapy — where a patient's own immune cells are engineered in a lab to recognize and destroy leukemia cells, specifically for children and young adults with a hard-to-treat blood cancer called acute lymphoblastic leukemia (ALL) whose cancer cells carry specific markers (CD19 and CD22). **You may be eligible if...** - You are 24 years old or younger - You have CD19- and CD22-positive ALL that has not responded to treatment, has relapsed (come back), or is considered too high-risk for standard treatments - Your overall health and organ function are above the minimum thresholds **You may NOT be eligible if...** - You have active hepatitis B, C, or HIV - Your oxygen levels, liver function, or kidney function are significantly abnormal - You are pregnant or breastfeeding - You have a pre-existing significant brain or nervous system condition (other than leukemia involvement) - Your leukemia cells do not carry the CD19 or CD22 markers - You have a severe active infection or require supplemental oxygen at the time of the planned cell infusion - You have severe graft-versus-host disease from a previous bone marrow transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURELeukapheresis

Patients will undergo an unstimulated leukapheresis to isolate the required immune cells to produce the CD19+CD22 CAR T-cells

RADIATIONTotal Body Irradiation (TBI)

Participants will receive low-dose total body irradiation delivered as a single fraction on day -7 prior to CD19+CD22CAR T-cell infusion.

DRUGLymphodepletion with Fludarabine

Patients will receive lymphodepleting chemotherapy with iv fludarabine on days -6 to -3 prior to CD19+CD22CAR T-cell infusion.

DRUGLymphodepletion with Cyclophosphamide

Patients will receive lymphodepleting chemotherapy with iv cyclophosphamide on days -6 to -5 prior to CD19+CD22CAR T-cell infusion.

BIOLOGICALCD19+CD22 CAR T-cells

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.


Locations(3)

Great Ormond Street Hospital

London, United Kingdom

University College Hospital

London, United Kingdom

Manchester Royal Children's Hospital

Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT02443831


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