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Trial Title:
GZL Sequential CD19/CD22 CAR-T in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
NCT ID:
NCT05797948
Condition:
Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Cyclophosphamide
Fludarabine
Lenalidomide
Azacitidine
Obinutuzumab
Zanubrutinib
Conditions: Keywords:
Humanized anti-CD20 monoclonal antibody
BTK Inhibitor
Immunomodulators
CAR-T
Study type:
Interventional
Study phase:
N/A
Overall status:
Enrolling by invitation
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Obinutuzumab
Description:
Obinutuzumab Injection 1000mg ivgtt C1-C4 d1；
Arm group label:
GZL sequential CD19/CD22 CAR-T
Other name:
Gazyva
Intervention type:
Drug
Intervention name:
Zanubrutinib
Description:
Zanubrutinib 160mg (2 capsules) oral bid；
Arm group label:
GZL sequential CD19/CD22 CAR-T
Other name:
Brukinsa
Intervention type:
Drug
Intervention name:
Lenalidomide
Description:
Lenalidomide 25mg (1 capsule) oral C1-C4 d1-d10.
Arm group label:
GZL sequential CD19/CD22 CAR-T
Other name:
Anxian
Intervention type:
Drug
Intervention name:
CD19/CD22 CAR-T
Description:
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.
Arm group label:
GZL sequential CD19/CD22 CAR-T
Intervention type:
Drug
Intervention name:
Azacitidine For Injection
Description:
Azacitidine For Injection 100mg i.h. d1-d5;
Arm group label:
GZL sequential CD19/CD22 CAR-T
Other name:
Anyve
Intervention type:
Drug
Intervention name:
Fludarabine
Description:
Fludarabine 300mg/m2 ivgtt d3-d5;
Arm group label:
GZL sequential CD19/CD22 CAR-T
Other name:
Fludara
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
Cyclophosphamide 300mg/m2 ivgtt d3-d5.
Arm group label:
GZL sequential CD19/CD22 CAR-T
Other name:
Endoxan
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 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.
2. Disease refractory to first-line therapy or early relapse within 12 months of last
treatment.
3. Relapse or progressive disease (PD) ≥ 3 months after targeted CD19 therapy including
CD19 CAR T cells or anti-CD19/anti-CD3.
4. Successful leukapheresis assessment and T-cell preculture.
5. Life expectancy > 3 months.
6. 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.
7. 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.
8. Measurable or evaluable lesions according to "IWG response criteria for malignant
lymphoma" (Cheson 2014).
9. Patients have the ability to understand and are willing to provide written informed
consent.
Exclusion Criteria:
1. severe liver and kidney dysfunction (alanine aminotransferase, bilirubin, creatinine
> 3 times the upper limit of normal);
2. the presence of structural heart disease, and lead to clinical symptoms or abnormal
heart function (NYHA ≥ 2);
3. uncontrolled active infection;
4. the presence of other tumors requiring treatment or intervention;
5. the current or expected need for systemic corticosteroid therapy;
6. pregnant or lactating women.
7. Other psychological conditions that prevent patients from participating in the study
or signing informed consent;
8. According to the investigator 's judgment, the subject is unlikely to complete all
protocol-required study visits or procedures, including follow-up visits, or fail to
meet the requirements for participation in the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
the First Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215006
Country:
China
Start date:
July 1, 2022
Completion date:
June 30, 2024
Lead sponsor:
Agency:
The First Affiliated Hospital of Soochow University
Agency class:
Other
Source:
The First Affiliated Hospital of Soochow University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05797948
