Actively Recruiting
The Safety, Tolerability, and Efficacy of IBR900 Cell Injection in Relapsed/Refractory B-cell Non Hodgkin Lymphoma
Led by Imbioray (Hangzhou) Biomedicine Co., Ltd. · Updated on 2025-07-18
40
Participants Needed
2
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Safety, Tolerability, and Efficacy of IBR900 Cell Injection in Relapsed/Refractory B-cell Non Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with CD20 positive B-cell non-Hodgkin lymphoma, including specified subtypes according to 2022 WHO classification
- Have relapsed or refractory B-NHL after at least 1 line (invasive) or 2 lines (indolent) of standard treatment including anti-CD20 therapy
- At least one measurable tumor lesion as per 2014 Lugano criteria
- Physical fitness status with ECOG score 0 to 2
- Agree to use effective contraception if of childbearing potential, with no fertility plans during the study
- Expected survival of at least 3 months
You will not qualify if you...
- Current or previous primary central nervous system lymphoma or secondary central nervous system involvement
- Received allogeneic hematopoietic stem cell transplant or organ transplant, or autologous transplant within 100 days prior to first dose
- Received attenuated live vaccine within 4 weeks prior to first dose or plan to during study
- History of malignant tumors within 5 years except certain cured skin or cervical cancers
- Active autoimmune diseases or history of recurrence, unless stable hypothyroidism or mild skin disease
- Major surgery within 28 days prior to first dose or planned during study
- Need for systemic corticosteroids >10mg prednisone or immunosuppressives within 7 days prior to first dose or during study (with exceptions)
- Active deep vein thrombosis or pulmonary embolism within 6 months before screening
- Active interstitial lung disease, non-infectious pneumonia, or tuberculosis infection
- Unstable systemic diseases like diabetes or serious cardiovascular/cerebrovascular conditions
- Heart conditions including low ejection fraction, significant heart failure, serious arrhythmias, or recent myocardial infarction or surgery
- HIV infection, positive hepatitis B or C with elevated viral loads
- Severe active infections during screening
- History of severe allergic reactions to monoclonal antibodies or study drug components
- Participation in other drug or device clinical trials within 4 weeks prior to first dose
- History of neurological or mental disorders affecting compliance
- Pregnant or breastfeeding women
- History of stroke or brain hemorrhage within 6 months
- Active or recent gastrointestinal bleeding within 6 months
- Any condition deemed unsuitable by investigators, including rapid disease progression during screening
AI-Screening
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Trial Site Locations
Total: 2 locations
1
The First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Actively Recruiting
2
Shanghai Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Actively Recruiting
Research Team
K
Kaiyan Ma
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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