NCT02443831

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 24 Years
• Healthy volunteers: Not accepted

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

Detailed description

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.

Conditions

• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
PROCEDURE	Leukapheresis	Patients will undergo an unstimulated leukapheresis to isolate the required immune cells to produce the CD19+CD22 CAR T-cells
RADIATION	Total Body Irradiation (TBI)	Participants will receive total body irradiation delivered as a single fraction (2Gy) on day -7 prior to CD19+CD22CAR T-cell infusion.
DRUG	Lymphodepletion with Fludarabine	Patients will receive lymphodepleting chemotherapy with iv fludarabine 30 mg/m2 on days -6 to -3 prior to CD19+CD22CAR T-cell infusion.
DRUG	Lymphodepletion with Cyclophosphamide	Patients will receive lymphodepleting chemotherapy with iv cyclophosphamide 0.5 g/m2 on days -6 to -5 prior to CD19+CD22CAR T-cell infusion.
BIOLOGICAL	CD19+CD22 CAR T-cells	Dose level 1: 2 doses of 4 x 10\^5 CD19+CD22 CAR T-cells/kg Dose level 2: 2 doses of 1 x 10\^6 CD19+CD22 CAR T-cells/kg given as a split dose as an intravenous injection through a Hickman line or PICC line (peripherally inserted central catheter) on day 0 and day 14.

Timeline

• Start date: 2016-04-01
• Primary completion: 2026-12-31
• Completion: 2041-12-31
• First posted: 2015-05-14
• Last updated: 2025-04-02

Locations

3 sites across 1 country: United Kingdom