An interventional study of Obinutuzumab and Zanubrutinib in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma, sponsored by The First Affiliated Hospital of Soochow University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-04.
Sponsored by The First Affiliated Hospital of Soochow University · Not applicable, Interventional, and Treatment
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 20 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →The First Affiliated Hospital of Soochow University is the lead sponsor of 252 studies on the registry; 148 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Histologically confirmed CD22 + and/or CD19 + aggressive B-cell non-Hodgkin lymphoma (NHL), including the following types as defined by World Health Organization (WHO) 2016:
Diffuse large B-cell lymphoma (DLBCL); High grade B-cell lymphoma (HGBL); Primary mediastinal large B-cell lymphoma(PMBCL); T cell/histiocyte-rich large B-cell lymphoma (THRBCL); High grade follicular cell lymphoma Grade 3b (3bFL); Mantle cell lymphoma (MCL) except indolent; Other aggressive B-cell lymphomas.
Appropriate organ function:
Creatinine \< 1.6 mg/dL (140 µmol/L) or creatinine clearance ≥ 60ml/min; Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) \< 3 × upper limit of normal; Bilirubin \< 2.0 mg/dL unless subject has Gilbert 's syndrome (\< 3.0 mg/dL); Pulmonary reserve ≤ Grade 1 dyspnea and SPO2 > 91%; Cardiac ejection fraction ≥ 50% in the absence of oxygen, no evidence of pericardial effusion as determined by echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings.
Adequate bone marrow reserve was defined as:
Absolute neutrophil count (ANC) > 1000/mm3; Absolute lymphocyte count (ALC) ≥ 300/mm3; Platelet count ≥ 50,000/mm3. Hemoglobin > 7.0 mg/dL.
Exclusion Criteria:
Phase I (combined immunotherapy period): 2-4 cycle of combination chem-free therapy with Obinutuzumab, Zanubrutinib and Lenalidomide . Each cycle is 21 days. Phase II (CAR-T therapy): CAR-T therapy with AZA + FC (Azacitidine, Fludarabine and Cyclophosphamide) conditioning regimen. Targets of CAR-T cells are CD19/CD22.
Drug: Obinutuzumab · Drug: Zanubrutinib · Drug: Lenalidomide · Drug: CD19/CD22 CAR-T · Drug: Azacitidine For Injection · Drug: Fludarabine · Drug: Cyclophosphamide
Obinutuzumab Injection 1000mg ivgtt C1-C4 d1；
Also known as: Gazyva
Zanubrutinib 160mg (2 capsules) oral bid；
Also known as: Brukinsa
Lenalidomide 25mg (1 capsule) oral C1-C4 d1-d10.
Also known as: Anxian
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;
Also known as: Anyve
Fludarabine 300mg/m2 ivgtt d3-d5;
Also known as: Fludara
Cyclophosphamide 300mg/m2 ivgtt d3-d5.
Also known as: Endoxan
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
Time frame: up to 24 months after the end of last patient's treatment
Plan to share: Yes — All the data would be available at the First Affiliated Hospital and other researchers after the end of the study.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital of Soochow University