Relapsed/Refractory B-cell Non-Hodgkin LymphomaPhase 1NCT07073833
The Safety, Tolerability, and Efficacy of IBR900 Cell Injection in Relapsed/Refractory B-cell Non Hodgkin Lymphoma
A Phase 1 study testing IBR900 cell injection and rituximab in people with Relapsed/Refractory B-cell Non-Hodgkin Lymphoma, run by Imbioray (Hangzhou) Biomedicine Co., Ltd. at 2 sites in China.
Trial summary
This is an open label clinical study: Phase Ia is a dose escalation phase, evaluating the safety, tolerability, RP2D, PK characteristics, and preliminary efficacy of IBR900 cell injection in the treatment of relapsed/refractory B-cell non Hodgkin lymphoma (NHL); Phase Ib is the dose expansion stage, which is divided… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
- What is being tested?
- IBR900 cell injection and rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jul 2025to 30 Jul 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Voluntarily sign the informed consent form, understand the study and be willing to follow the protocol and complete all experimental procedures;
- Male or female, age ≥ 18 years old;
- CD20 positive B-cell non Hodgkin's lymphoma (B-NHL), including but not limited to diffuse large B-cell lymphoma non-specific, high-grade B-cell lymphoma with MYC and BCL2 rearrangements, high-grade B-cell lymphoma with MYC/BCL2/BCL6 rearrangements, high-grade B-cell lymphoma non-specific, primary mediastinal B-cell lymphoma, grade 3b follicular lymphoma, indolent B-cell lymphoma (mantle cell lymphoma (MCL), marginal zone B-cell lymphoma (MZL)), slow lymphocytic transformed large B-cell lymphoma with previous treatment of anthracycline containing drugs and rituximab or other CD20 targeted therapies, that meets the criteria of the 2022 WHO classification of lymphoid tissue tumors. Adequate treatment with medication. Among them, inert B-NHL must have received at least 2 lines or more of standard treatment failure, while invasive B-NHL must have received at least 1 line or more of standard treatment failure. At least one regimen contains anti-CD20 monoclonal antibody monotherapy or combination therapy; Note: Relapse is defined as disease progression after sufficient treatment to achieve remission (CR or PR), with at least one regimen containing anti-CD20; Difficult to treat is defined as disease progression (PD or SD) within 6 months after full treatment with an anti-CD20 regimen without remission, or during the treatment period/after the end of full treatment;
- At least one measurable tumor lesion. Measurable lesions (2014 Lugano lymphoma efficacy evaluation criteria): longest diameter of lymph nodes>15mm, extranodal lesions>10mm; lesions that have received local treatment such as radiotherapy before, if disease progression has been proven, are considered measurable lesions;
- The ECOG score for physical fitness status ranges from 0 to 2 points;
- Female or male participants of childbearing age should agree to have no fertility plans and take effective contraceptive measures within 6 months from the signing of the ICF until the last dose of the study drug is used;
- Expected survival period is at least 3 months.
Who cannot join
- Patients with current or previous primary central nervous system lymphoma (PCNSL) or secondary central nervous system involvement. Patients with central nervous system symptoms must undergo lumbar puncture and magnetic resonance imaging (MRI) examination to exclude them;
- Patients who have received allogeneic hematopoietic stem cell transplantation and other organ transplantation, or who have received autologous hematopoietic stem cell transplantation within 100 days before the first dose;
- Receive attenuated live vaccine within 4 weeks before the first administration or plan to receive it during the study period;
- Patients with a history of malignant tumors within the past 5 years, except for those who have been completely cured of basal cell carcinoma of the skin or squamous cell carcinoma of the skin, melanoma in situ, and cervical carcinoma in situ, and/or any malignant tumor patients who have been cured without disease or have had no disease for at least 5 consecutive years;
- Patients with active autoimmune diseases or a history of possible recurrence (such as systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, etc.), or high-risk patients. But the following patients may be considered for inclusion if the researchers assess disease stability: autoimmune hypothyroidism that only requires hormone replacement therapy; Skin diseases that do not require systemic treatment (such as eczema, rash that accounts for less than 10% of the body surface);
- Patients who have undergone major surgery within 28 days prior to the first administration or are expected to undergo major surgery during the study period;
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- Subjects who require systemic corticosteroid treatment (>10mg/day prednisone or equivalent) or other immunosuppressive drugs within 7 days prior to the first administration or during the study period, but excluding topical corticosteroids via nasal spray, inhalation, or other routes, or systemic corticosteroids at physiological doses;
- Subjects with active deep vein thrombosis or pulmonary embolism within the first 6 months of screening;
- Patients currently suffering from interstitial lung disease or non infectious pneumonia, with active tuberculosis infection;
- Systemic diseases not stably controlled after treatment, such as diabetes, serious organic cardiovascular and cerebrovascular diseases;
- The patient's heart meets any of the following conditions: left ventricular ejection fraction (LVEF) ≤ 55%; New York Heart Association (NYHA) (see Appendix 3) Grade II or above congestive heart failure or active heart disease; Serious arrhythmias that require treatment (excluding atrial fibrillation and paroxysmal supraventricular tachycardia that have been determined by the researchers to have no impact on the trial); QTc interval ≥ 450ms for males and ≥ 470ms for females (QTc formula in Appendix 4); Within 6 months prior to administration, there has been a myocardial infarction or bypass or stent surgery; Other heart diseases deemed unsuitable for inclusion by researchers;
- Human immunodeficiency virus (HIV) infection, hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) are positive during screening period, and HBV-DNA is higher than the normal range of the laboratory in the center; Patients who are positive for HCV antibodies during the screening period and have HCV-RNA levels higher than the normal range of the laboratory in their center;
- Evidence of uncontrollable and severe active infections during screening (such as sepsis, bacteremia, mycosis, viremia, etc.);
- Known subjects who have experienced severe allergic reactions to macromolecular protein preparations/monoclonal antibodies, as well as any components of the investigational drug in the past (CTCAE v5.0 grade ≥ 3);
- Participated in clinical trials of other intervention drugs or medical devices within 4 weeks prior to the first administration of this study, or is currently undergoing treatment in other clinical trials (excluding non intervention studies);
- Patients with a clear history of neurological or mental disorders, such as epilepsy, dementia, and poor compliance;
- Pregnant or lactating women;
- History of stroke or intracranial hemorrhage within 6 months;
- Active or documented gastrointestinal bleeding within 6 months (such as esophageal or gastric varices, ulcer bleeding);
- Researchers believe that patients who are not suitable to participate in the trial due to other reasons, such as rapid disease progression during the screening period.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang
Hongyan Tong, 8613958122357, hongyantong@aliyun.com
- Recruiting
Shanghai Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Weili Zhao, 8613512112076, zwl_trial@163.com
About this study
Official title: An Open Label, Multicenter Phase I Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of IBR900 Cell Injection in the Treatment of Relapsed/Refractory CD20 Positive B-cell Non Hodgkin Lymphoma
This is an open label clinical study: Phase Ia is a dose escalation phase, evaluating the safety, tolerability, RP2D, PK characteristics, and preliminary efficacy of IBR900 cell injection in the treatment of relapsed/refractory B-cell non Hodgkin lymphoma (NHL); Phase Ib is the dose expansion stage, which is divided into two parts: monotherapy expansion (queue 1) and combination expansion (queue 2). The monotherapy expansion part evaluates the safety, tolerability, and preliminary efficacy of IBR900 cell injection in the treatment of relapsed/refractory CD20 positive B-cell non Hodgkin lymphoma, while the combination expansion part evaluates the safety, tolerability, and preliminary efficacy of IBR900 cell injection combined with CD20 monoclonal antibodies in the treatment of relapsed/refractory CD20 positive B-cell non Hodgkin lymphoma.
- Being tested
- IBR900 cell injection, rituximab
- 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.
IBR900 cell injectionDrug
NK cells
rituximabDrug
CD20 antibody
| Study group | Role | What they receive |
|---|---|---|
| Phase Ia，single-agent dose escalation of IBR900 cell injection | Experimental | Not described Receives: Drug: IBR900 cell injection |
| Phase Ib，monotherapy expansion (queue 1) | Experimental | Not described Receives: Drug: IBR900 cell injection |
| Phase Ib，combination expansion (queue 2) | Experimental | Not described Receives: Drug: IBR900 cell injection; Drug: rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicity (DLT)
To evaluate the safety, tolerability, and determine the RP2D of IBR900 cell injection
Measured: From day1 to day 21
The incidence and severity of adverse events (AEs)
To evaluate the safety of IBR900 cell injection
Measured: From day 1 to day 30 after the last dose
Secondary outcomes (5)
Complete response rate (CR)
The rate of subjects who achieved complete remission (CR) among all subjects
Measured: From day 1 up to 9weeks
partial response rate (PR)
The rate of subjects who achieved partial remission (CR) among all subjects
Measured: From day 1 up to 9weeks
objective response rate (ORR, including CR+PR)
The rate of subjects achieving CR and partial remission(PR) among all subjects
Measured: From day 1 up to 9weeks
Duration of remission (DOR)
Time from the subject's first assessment of the onset of remission to the first assessment of disease recurrence or progression or death from any cause
Measured: From day 1 up to disease recurrence ， progression or death because of any cause (maximun duration: 2.5 years ).
Overall survival (OS)
Time from the start of treatment to death from any cause
Measured: From day 1 up to death of any cause or follow-up loss (maximum duration : 4 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start1 Jul 2025
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory B-cell Non-Hodgkin LymphomaStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imbioray (Hangzhou) Biomedicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073833
- Sponsor's protocol ID
- IBR900-101
- Status last verified
- Jul 2026
- First submitted
- 26 Jun 2025
- Last updated
- 2 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multicenter Phase I Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of IBR900 Cell Injection in the Treatment of Relapsed/Refractory CD20 Positive B-cell Non Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT07073833
- Acronym / sponsor ID
- IBR900-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Imbioray (Hangzhou) Biomedicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 18 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label clinical study: Phase Ia is a dose escalation phase, evaluating the safety, tolerability, RP2D, PK characteristics, and preliminary efficacy of IBR900 cell injection in the treatment of relapsed/refractory B-cell non Hodgkin lymphoma (NHL); Phase Ib is the dose expansion stage, which is divided into two parts: monotherapy expansion (queue 1) and combination expansion (queue 2). The monotherapy expansion part evaluates the safety, tolerability, and preliminary efficacy of IBR900 cell injection in the treatment of relapsed/refractory CD20 positive B-cell non Hodgkin lymphoma, while the combination expansion part evaluates the safety, tolerability, and preliminary efficacy of IBR900 cell injection combined with CD20 monoclonal antibodies in the treatment of relapsed/refractory CD20 positive B-cell non Hodgkin lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase Ia，single-agent dose escalation of IBR900 cell injection | Experimental | Drug: IBR900 cell injection |
| Phase Ib，monotherapy expansion (queue 1) | Experimental | Drug: IBR900 cell injection |
| Phase Ib，combination expansion (queue 2) | Experimental | Drug: IBR900 cell injection, Drug: rituximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Voluntarily sign the informed consent form, understand the study and be willing to follow the protocol and complete all experimental procedures;
- Male or female, age ≥ 18 years old;
- CD20 positive B-cell non Hodgkin's lymphoma (B-NHL), including but not limited to diffuse large B-cell lymphoma non-specific, high-grade B-cell lymphoma with MYC and BCL2 rearrangements, high-grade B-cell lymphoma with MYC/BCL2/BCL6 rearrangements, high-grade B-cell lymphoma non-specific, primary mediastinal B-cell lymphoma, grade 3b follicular lymphoma, indolent B-cell lymphoma (mantle cell lymphoma (MCL), marginal zone B-cell lymphoma (MZL)), slow lymphocytic transformed large B-cell lymphoma with previous treatment of anthracycline containing drugs and rituximab or other CD20 targeted therapies, that meets the criteria of the 2022 WHO classification of lymphoid tissue tumors. Adequate treatment with medication. Among them, inert B-NHL must have received at least 2 lines or more of standard treatment failure, while invasive B-NHL must have received at least 1 line or more of standard treatment failure. At least one regimen contains anti-CD20 monoclonal antibody monotherapy or combination therapy; Note: Relapse is defined as disease progression after sufficient treatment to achieve remission (CR or PR), with at least one regimen containing anti-CD20; Difficult to treat is defined as disease progression (PD or SD) within 6 months after full treatment with an anti-CD20 regimen without remission, or during the treatment period/after the end of full treatment;
- At least one measurable tumor lesion. Measurable lesions (2014 Lugano lymphoma efficacy evaluation criteria): longest diameter of lymph nodes>15mm, extranodal lesions>10mm; lesions that have received local treatment such as radiotherapy before, if disease progression has been proven, are considered measurable lesions;
- The ECOG score for physical fitness status ranges from 0 to 2 points;
Key exclusion criteria (20 listed)
- Patients with current or previous primary central nervous system lymphoma (PCNSL) or secondary central nervous system involvement. Patients with central nervous system symptoms must undergo lumbar puncture and magnetic resonance imaging (MRI) examination to exclude them;
- Patients who have received allogeneic hematopoietic stem cell transplantation and other organ transplantation, or who have received autologous hematopoietic stem cell transplantation within 100 days before the first dose;
- Receive attenuated live vaccine within 4 weeks before the first administration or plan to receive it during the study period;
- Patients with a history of malignant tumors within the past 5 years, except for those who have been completely cured of basal cell carcinoma of the skin or squamous cell carcinoma of the skin, melanoma in situ, and cervical carcinoma in situ, and/or any malignant tumor patients who have been cured without disease or have had no disease for at least 5 consecutive years;
- Patients with active autoimmune diseases or a history of possible recurrence (such as systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, etc.), or high-risk patients. But the following patients may be considered for inclusion if the researchers assess disease stability: autoimmune hypothyroidism that only requires hormone replacement therapy; Skin diseases that do not require systemic treatment (such as eczema, rash that accounts for less than 10% of the body surface);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IBR900 cell injectionNK cells | Drug | Phase Ia，single-agent dose escalation of IBR900 cell injection, Phase Ib，combination expansion (queue 2), Phase Ib，monotherapy expansion (queue 1) |
| rituximabCD20 antibody | Drug | Phase Ib，combination expansion (queue 2) |
Primary outcome
Incidence of dose limiting toxicity (DLT)
Time frame: From day1 to day 21
To evaluate the safety, tolerability, and determine the RP2D of IBR900 cell injection
The incidence and severity of adverse events (AEs)
Time frame: From day 1 to day 30 after the last dose
To evaluate the safety of IBR900 cell injection
5 secondary outcomes
Complete response rate (CR)
Time frame: From day 1 up to 9weeks
partial response rate (PR)
Time frame: From day 1 up to 9weeks
objective response rate (ORR, including CR+PR)
Time frame: From day 1 up to 9weeks
Duration of remission (DOR)
Time frame: From day 1 up to disease recurrence ， progression or death because of any cause (maximun duration: 2.5 years ).
Overall survival (OS)
Time frame: From day 1 up to death of any cause or follow-up loss (maximum duration : 4 years).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IBR900 cell injection and rituximab in people with Relapsed/Refractory B-cell Non-Hodgkin Lymphoma, run by Imbioray (Hangzhou) Biomedicine Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaiyan Ma (8618810195090, kaiyan.ma@imbioray.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose limiting toxicity (DLT) (time frame: From day1 to day 21). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.