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Tests treatment safety and results for Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Official title The Safety, Tolerability, and Efficacy of IBR900 Cell Injection in Relapsed/Refractory B-cell Non Hodgkin Lymphoma
ClinicalTrials.gov ID: NCT07073833
What this study is testing
What is IBR900 cell injection?
IBR900 cell injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for relapsed/refractory b-cell non-hodgkin lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- At least one measurable tumor lesion. Measurable lesions (2014 Lugano lymphoma how well it works evaluation criteria): longest diameter of lymph...
- The ECOG score for physical fitness status ranges from 0 to 2 points;
You likely can't join if
- Patients with current or previous primary central nervous system lymphoma (PCNSL) or secondary central nervous system involvement. Patients with...
- Patients who have received allogeneic hematopoietic stem cell transplantation and other organ transplantation, or who have received autologous...
- 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...
- Patients with active autoimmune diseases or a history of possible recurrence (such as systemic lupus erythematosus, rheumatoid arthritis...
- Patients who have undergone major surgery within 28 days prior to the first administration or are expected to undergo major surgery during the study...
See the full eligibility criteria
Who can 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...
- At least one measurable tumor lesion. Measurable lesions (2014 Lugano lymphoma how well it works evaluation criteria): longest diameter of lymph nodes\>15mm, extranodal lesions\>10mm; lesions that have received local...
- 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.
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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;
- people 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...
- people 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...
- 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...
- Evidence of uncontrollable and severe active infections during screening (such as sepsis, bacteremia, mycosis, viremia, etc.);
- Known people 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China; Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.