NCT03191773

A Study of Anti-CD19 CAR-T Cell Immunotherapy for Refractory /Relapsed B Cell Malignancies

A Prospective, Multicenter, Single-Arm Study of Anti-CD19 CAR-T Cell Immunotherapy for Refractory /Relapsed B Cell Malignancies

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Second Affiliated Hospital of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 14 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Autologous T cells engineered to express an anti-CD19 chimeric antigen receptor (CAR) will be infused back to patients with refractory /relapsed B cell malignancies, including lymphoma and leukemia. The patients will be monitored after infusion of anti-CD19 CAR-transduced T cells for safety,adverse events, persistence of anti-CD19 CAR-transduced T cells and treatment efficacy.

Detailed description

Despite progress has been made to date in the treatment of patients with B cell malignancies, including leukemia and lymphoma, many patients with relapsed or refractory diseases do not respond to the standard treatments. It has been shown that anti-CD19 CAR-transduced T cells may be an effective approach to treat the relapsed or refractory diseases. The procedure involves collecting PBMCs from the patients and modifying the T cells to attack the malignant B cells. In this trial, autologous T cells engineered to express an anti-CD19 chimeric antigen receptor (CAR) containing the signaling domains of CD28 or 4-1BB and CD3-zeta will be infused back to patients with B cell malignancies, including lymphoma and leukemia. The patients will be pretreated with a lymphodepleting preconditioning regimen before the infusion of anti-CD19 CAR T cells, and will be monitored for safety, adverse events, persistence of anti-CD19 CAR-transduced T cells and the treatment efficacy.

Conditions

• Acute Lymphocytic Leukemia
• Chronic Lymphocytic Leukemia
• Lymphoma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Drugs and anti-CD19 CAR transduced T cells	Drug: Fludarabine On days -4 through -2, Fludarabine 30mg/m2 (IV) will be infused over 30 minutes. Drug: Cyclophosphamide On days -4 through -2, Cyclophosphamide 300-500mg/m2 IV will be infused over 60 minutes followed by fludarabine. Biological: Anti-CD19-CAR T cells On day 0, cells will be infused intravenously IV over 20 - 30 minutes.

Timeline

• Start date: 2017-06-30
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2017-06-19
• Last updated: 2017-06-20

Locations

5 sites across 1 country: China