NCT04626765

CAR-T for Children With Relapsed and Refractory Acute Lymphoblastic Leukemia

An Open, Uncontrolled, Multicenter Clinical Trial to Explore the Safety, Efficacy, and Remission Phase of Chimeric Antigen Receptor T Cell (CAR-T) in the Treatment of Children With Relapsed and Refractory Acute Lymphoblastic Leukemia

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Hebei Senlang Biotechnology Inc., Ltd. · Industry
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

Summary

In this study, CAR-T will be administered to children with acute lymphoblastic leukemia to explore the effect of CAR-T intervention time on the duration of complete remission and further verify the long-term safety and efficacy of CAR-T treatment.

Detailed description

After clinician evaluation, if the child meets the study criteria and after adequate communication, the parent or legal guardian voluntarily joins the clinical study, CAR-T technique can be used for related treatment, and the long-term therapeutic effect can be observed. In this trial, 50 children were publicly enrolled and treated with CAR-T. Patients participating in the clinical trial will be tested and assessed in terms of treatment safety, efficacy, and duration of response.

Conditions

• Childhood Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	CD19 CAR-T	CD19 CAR-T infusion for pediatric patients with CD19 positive tumor cells
DRUG	CD22 CAR-T	CD22 CAR-T infusion for pediatric patients with CD22 positive tumor cells
DRUG	CD 19+22	CD19+22 CAR-T infusion for pediatric patients with CD19 positive and CD22 positive tumor cells
DRUG	Fludarabine	25mg/㎡ for D-4、D-3 and D-2
DRUG	Cyclophosphamide	500mg/㎡ for D-3 and D-2

Timeline

• Start date: 2020-04-01
• Primary completion: 2023-03-30
• Completion: 2023-05-30
• First posted: 2020-11-13
• Last updated: 2020-11-13

Locations

1 site across 1 country: China