This is a single-center, open-label, prospective study enrolling high-risk (tumor diameter \> 4 cm) relapsed/refractory B-NHL patients ineligible for HDCT and ASCT. The treatment consists of ATRA combined with zanubrutinib ± radiotherapy and CAR-T therapy. Based on the efficacy at day 28 post-CAR-T infusion, patients achieving CR will receive 3 months of ATRA and zanubrutinib, while those with PR will receive 3 months of zanubrutinib plus 2 years of ATRA and a PD-1 inhibitor. Patients with stable disease or progression will discontinue. The primary endpoint is the 3-month CR rate following CAR-T infusion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
10mg,tid,po (After apheresis and continued until post-infusion)
160mg,bid,po (prior to apheresis and continued until post-infusion)
If the patient's specific lesions are suitable for radiotherapy
CAR-T cell therapy
IV 200 mg on D1, Q3W
Department of Hematology, Shanghai Institute of Hematology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Complete Response (CR) Rate at 3-month
Complete response rate at 3-month is defined as the incidence of subjects achieving complete remission (CR) within 3 months after CAR-T infusion according to the Lugano Classification (Cheson et al, 2014), as determined by study investigators.
Time frame: 3 months post CAR-T infusion
Progression-Free Survival (PFS)
PFS is defined as the time from the CAR-T infusion date to the date of disease progression or death from any cause.
Time frame: 2 years post CAR-T infusion
Overall Survival (OS)
OS is defined as the time from CAR-T infusion to the date of death from any cause.
Time frame: 2 years post CAR-T infusion
Adverse Events rate as assessed by CTCAE version 5.0
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time frame: 2 years post CAR-T infusion
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