B-Cell Non-Hodgkin Lymphoma (NHL)NCT07888530
Non-Interventional Study of Ranicabtagene Autoleucel Injection for Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
An observational study of B-Cell Non-Hodgkin Lymphoma (NHL), run by Hrain Biotechnology Co., Ltd..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-Cell Non-Hodgkin Lymphoma (NHL)
- What is being tested?
- Ranicabtagene Autoleucel Injection
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2026to 31 Dec 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Diagnosed as relapsed/refractory B cell Non-Hodgkin Lymphoma through cytological or pathological tissue examination according to the WHO 2016 standards
- Age ≥18 years old
- 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.
- Voluntarily participate in this study and sign the informed consent form. For patients who do not have full capacity for civil conduct, informed consent must also be obtained from their legal guardians
Who cannot join
- Patients who previously received CAR-T cell therapy targeting CD19
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Non-Interventional Study of Ranicabtagene Autoleucel Injection for Relapsed/Refractory B-cell Non-Hodgkin Lymphoma (B-NHL)
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.
Read the detailed description
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.
- Conditions
- B-Cell Non-Hodgkin Lymphoma (NHL)
- Being tested
- Ranicabtagene Autoleucel Injection
- Keywords
- Chimeric antigen receptor T cells, B-cell Non-Hodgkin Lymphoma, Relapsed /Refractory, Ranicabtagene Autoleucel Injection
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ranicabtagene Autoleucel InjectionDrug
Also called HR001, HICARA
Ranicabtagene Autoleucel Injection Autologous genetically modified anti-CD19 CAR-T cells
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS) after administration [Effectiveness Metrics]
The time from Ranicabtagene Autoleucel Injection infusion to death from any cause.
Measured: 5 years post infusion
Secondary outcomes (10)
Overall response rate (ORR) [Effectiveness Metrics]
Percentage of participants with CR or PR.
Measured: 5 years post infusion
Complete response rate (CRR) [Effectiveness Metrics]
Percentage of participants with CR.
Measured: 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.
Measured: 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.
Measured: 5 years post infusion
Cytokine release syndrome (CRS) [Safety Indicators]
Percentage of participants with CRS.
Measured: 5 years post infusion
Immune effector cell-associated neurotoxicity syndrome (ICANS) [Safety Indicators]
Percentage of participants with ICANS.
Measured: 5 years post infusion
Severe infection [Safety Indicators]
Percentage of participants with severe infection.
Measured: 5 years post infusion
B cell aplasia and hypogammaglobulinemia [Safety Indicators]
Percentage of participants with B cell aplasia and hypogammaglobulinemia.
Measured: 5 years post infusion
Prolonged cytopenia [Safety Indicators]
Percentage of participants with prolonged cytopenia.
Measured: 5 years post infusion
Abnormal laboratory results [Safety Indicators]
Percentage of participants with abnormal laboratory results.
Measured: 5 years post infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start30 Oct 2026 (estimated)
- Primary completion30 Jun 2030 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-Cell Non-Hodgkin Lymphoma (NHL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Hrain Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zhujiang Hospital
- Responsible party
- Sponsor
- Investigators
- Yuhua Li, Ph.D., Principal investigator, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888530
- Sponsor's protocol ID
- HRAIN01-NHL01-R1
- Other IDs
- CTR20263794
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No