Large B-Cell Lymphoma (LBCL)
Conditions
Keywords
CD19, Large B-Cell Lymphoma, CAR-T
Brief summary
A Study of CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma
Detailed description
This study is indicated for patients with CD19+ newly diagnosed high-risk large B-cell lymphoma. This study is an investigator-initiated, single-center, single-arm phase II clinical trial of rituximab, lenalidomide, and zanubrutinib (ZR2) with Sequential CAR-T cell as first-line therapy for newly diagnosed high-risk LBCL. Primary objective is to explore the efficacy and also safety.
Interventions
DRUGCD19 CAR-T cells
Each subject receive CD19 CAR T-cells by intravenous infusion
Sponsors
Zhejiang University
Yake Biotechnology Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age no less than 18, no gender limit; 2. Newly diagnosed high-risk Large B-cell Lymphoma, which was defined by the following criteria: (1) DLBCL not otherwise specified with an IPI score ≥3 at diagnosis, (2) high grade B-cell lymphoma (HGBL) with gene rearrangement of MYC and BCL2 and/or BCL6, (3) HGBL not otherwise specified; 3. Confirmed CD19 and CD20 postive expressions in lymphoma cells 4. ECOG score 0-2; 5. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L; 6. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%; 7. No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%; 8. Estimated survival time ≥ 3 months; 9. Patients or their legal guardians volunteer to participate in the study and sign the informed consent.
Exclusion criteria
1. Central nervous system involvement by lymphoma；History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases; 2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past; 3. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis); 4. Active infection of hepatitis B virus or hepatitis C virus; 5. Previously treated with any CAR-T cell product or other genetically modified T cell therapies; 6. Insufficient amplification capacity in response to CD3/CD28 co-stimulus signal (\<5 times) ; 7. Other uncontrolled diseases that were not suitable for this trial; 8. Patients with HIV infection; 9. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete remission rate after CD19 CAR-T cell therapy | 3 months after CD19 CAR-T cell therapy | Assessment of complete remission rate at 3 months after CD19 CAR-T cell therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate (ORR) | After ZR2, 3 months after CAR-T cell therapy | Assessment of ORR after ZR2 and CAR-T cell therapy |
| Overall survival (OS) | Up to 2 years after CD19 CAR-T cells infusion | From the start of treatment to death or the last visit |
| Progression-free survival (PFS) | Up to 2 years after CD19 CAR-T cells infusion | From the start of the treatment to the occurrence of any event, including death, disease progression (any one occurs first), or the last visit |
| Duration of response (DOR) | Up to 2 years after CD19 CAR-T cells infusion | among patients experiencing an objective response, defined as the time from the first objective response to events of disease progression or death from any cause |
| Incidence of treatment-emergent adverse events (TEAEs) | Up to 2 years after CD19 targeted CAR T-cells infusion | Incidence of treatment-emergent adverse events \[Safety and Tolerability\] |
Countries
China
Contacts
CONTACTHe Huang, PhD
CONTACTYongxian Hu, PhD
Outcome results
None listed