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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Obinutuzumab Injection 1000mg ivgtt C1-C4 d1;
Zanubrutinib 160mg (2 capsules) oral bid;
Lenalidomide 25mg (1 capsule) oral C1-C4 d1-d10.
the First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Overall response rate (ORR) after GZL therapy
the rate of patients who achieved CR or PR after GZL therapy
Time frame: At the end of GZL therapy (2-4 cycles, each cycle is 21days)
Complete response rate (CRR) after CAR-T
the best rate of patients who achieved CR after CAR-T therapy
Time frame: Within 3 months after CAR-T therapy
Progression-free survival (PFS) after CAR-T
PFS will be assessed from the GZL combination therapy given to date of progression, relapse, death or end of follow-up.
Time frame: up to 24 months after the end of last patient's treatment
Incidence of treatment-emergent adverse events, treatment-related adverse events and serious adverse events
The safety and tolerability of the therapeutic regimen measured by the incidence of Treatment-Emergent Adverse Event.
Time frame: Initiation of GZL therapy until 30 days after CAR-T therapy
Overall response rate (ORR) after CAR-T
The best rate of patients who achieved CR or PR after CAR-T therapy
Time frame: Within 3 months after CAR-T therapy
Overall survival (OS) after CAR-T
OS will be assessed from the GZL combination therapy given to date of death or end of follow-up.
Time frame: up to 24 months after the end of last patient's treatment
Duration of Response(DOR) after CAR-T
DOR will be assessed from the date of CAR-T infusion to the date of progression, relapse, death or end of follow-up
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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.
Azacitidine For Injection 100mg i.h. d1-d5;
Fludarabine 300mg/m2 ivgtt d3-d5;
Cyclophosphamide 300mg/m2 ivgtt d3-d5.
Time frame: up to 24 months after the end of last patient's treatment