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.
• 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.