An observational study in B-Cell Non-Hodgkin Lymphoma (NHL), sponsored by Hrain Biotechnology Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Hrain Biotechnology Co., Ltd. · Observational
Establishing real-world data of patients with relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL) treated with Ranicabtagene Autoleucel Injection to evaluate its efficacy and safety.
This study is a single-arm, observational, real-world study. The purpose of this study is to collect efficacy and safety data over a 5-year period following treatment of adult patients with r/r B-NHL with Ranicabtagene Autoleucel Injection. This study is expected to enroll no fewer than 200 patients.
1,415 studies on the registry are indexed under Lymphoma, B-Cell; 328 are open to participants now.
This study's planned enrollment of 200 is above the median of 153 across 128 observational studies indexed under Lymphoma, B-Cell.
Browse Lymphoma, B-Cell studies →Hrain Biotechnology Co., Ltd. is the lead sponsor of 15 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Relapsed/refractory B cell Non-Hodgkin Lymphoma patients who have already received treatment with Ranicabtagene Autoleucel Injection through commercial channels at a study center in China that has obtained the commercial certification by HRAIN Biotechnology Co., Ltd.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Ranicabtagene Autoleucel Injection Autologous genetically modified anti-CD19 CAR-T cells
Also known as: HR001, HICARA
Overall Survival (OS) after administration [Effectiveness Metrics]
The time from Ranicabtagene Autoleucel Injection infusion to death from any cause.
Time frame: 5 years post infusion
Overall response rate (ORR) [Effectiveness Metrics]
Percentage of participants with CR or PR.
Time frame: 5 years post infusion
Complete response rate (CRR) [Effectiveness Metrics]
Percentage of participants with CR.
Time frame: 5 years post infusion
Duration of remission (DOR) [Effectiveness Metrics]
The time from the first tumor assessment showing CR or PR to the first assessment of disease progression or death from any cause.
Time frame: 5 years post infusion
Progression free survival (PFS) [Effectiveness Metrics]
The time from Ranicabtagene Autoleucel Injection infusion to the first assessment of tumor progression or death from any cause.
Time frame: 5 years post infusion
Cytokine release syndrome (CRS) [Safety Indicators]
Percentage of participants with CRS.
Time frame: 5 years post infusion
Immune effector cell-associated neurotoxicity syndrome (ICANS) [Safety Indicators]
Percentage of participants with ICANS.
Time frame: 5 years post infusion
Severe infection [Safety Indicators]
Percentage of participants with severe infection.
Time frame: 5 years post infusion
B cell aplasia and hypogammaglobulinemia [Safety Indicators]
Percentage of participants with B cell aplasia and hypogammaglobulinemia.
Time frame: 5 years post infusion
Prolonged cytopenia [Safety Indicators]
Percentage of participants with prolonged cytopenia.
Time frame: 5 years post infusion
Abnormal laboratory results [Safety Indicators]
Percentage of participants with abnormal laboratory results.
Time frame: 5 years post infusion
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Hrain Biotechnology Co., Ltd.