NCT05797948

GZL Sequential CD19/CD22 CAR-T in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Prospective, Single-center, Single-arm, Open-label Study of Obinutuzumab, Zanubrutinib and Lenalidomide Sequential CD19/CD22 CAR-T in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study intends to use Obinutuzumab, Zanubrutinib, and Lenalidomide sequential CD19/CD22 CAR-T in the treatment of Relapsed or Refractory B-cell Non-Hodgkin Lymphoma patients. The main purpose of this study is to explore a new treatment mode for R/R B-NHL patients and observe the efficacy and safety of this treatment regimen.

Detailed description

The study will start with 2-4 cycles of combination chem-free therapy with obinutuzumab, zanubrutinib and lenalidomide, followed by sequential CAR-T therapy. CAR-T therapy with AZA + FC (Azacitidine +Fludarabine +Cyclophosphamide) conditioning regimen. Targets of CAR-T cells are CD19/CD22. In this clinical trial, ORR, CRR, OS, PFS, AE and other indicators were used to observe the safety and efficacy of this sequential therapy.

Conditions

• Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Obinutuzumab	Obinutuzumab Injection 1000mg ivgtt C1-C4 d1；
DRUG	Zanubrutinib	Zanubrutinib 160mg (2 capsules) oral bid；
DRUG	Lenalidomide	Lenalidomide 25mg (1 capsule) oral C1-C4 d1-d10.
DRUG	CD19/CD22 CAR-T	Targets of CAR-T cells are tandem CD19/CD22. 1 \* 10 \^ 7/kg dual-target CAR-T cells were reinfused with 10%, 30% and 60% of the total dose on d1, d2, d3 respectively.
DRUG	Azacitidine For Injection	Azacitidine For Injection 100mg i.h. d1-d5;
DRUG	Fludarabine	Fludarabine 300mg/m2 ivgtt d3-d5;
DRUG	Cyclophosphamide	Cyclophosphamide 300mg/m2 ivgtt d3-d5.

Timeline

• Start date: 2022-07-01
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2023-04-04
• Last updated: 2023-04-04

Locations

1 site across 1 country: China