NL-OMON56086尚未招募不适用
A first-in-human dose escalation and expansion study with the SIRPa-directed monoclonal antibody BYON4228 alone and in combination with rituximab to evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy in patients with relapsed/refractory CD20 positive B-cell Non-Hodgkin*s Lymphoma (NHL) - BYON4228
Byondis Bv.0 个研究点目标入组 8 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Male or female, age >= 18 years at the time of signing informed consent; 2.
- •Patient with: a. Part 1 only: (Aggressive or indolent) B-cell NHL expressing
- •CD20 by immunohistochemistry (IHC) or flow cytometry, R/R to at least 2 prior
- •lines of therapy or autologous CAR-T cell therapy; b. Part 2 cohort A only:
- •Histologically confirmed aggressive B cell NHL (e.g., DLBCL, MCL) expressing
- •CD20 by IHC or flow cytometry, R/R to frontline therapy, or second line salvage
- •regimens or autologous hematopoietic cell transplantation, or autologous CAR-T
- •therapy; c. Part 2 cohort B only: Histologically confirmed indolent B-cell NHL
- •(e.g., marginal zone, follicular lymphoma (Grade 1-3a) expressing CD20 by IHC
- •or flow cytometry, R/R to at least 2 prior lines of therapy; For both parts:
- •autologous hematopoietic stem cell transplantation (HSCT) and autologous CAR-T
- •cell therapy (if more than 3 months prior to start IMP), and allogeneic HSCT
- •(if more than 6 months prior to start IMP) are allowed as prior lines. 3.
- •Eastern Cooperative Oncology Group (ECOG) performance status <= 1; 4. For Part 2
- •only: Disease that is measurable or assessable for response per Lugano
- •Classification for lymphomas; 5. Laboratory measurements, blood counts (Growth
- •Factor (GF) support and blood transfusions are not allowed within 2 weeks prior
- •to this assessment): a. Hemoglobin >= 8.5 g/dL (> 5.28 mmol/L); b. Absolute
- •neutrophil count (ANC) >= 1.0 × 109/mL; c. Platelet counts >= 50 × 109/mL; If
- •bone marrow involvement: >= 25 × 109/mL;
- •6. Laboratory measurements, hepatic function: a. Aspartate aminotransferase
- •(AST)/alanine aminotransferase (ALT) < 5 × upper limit of normal (ULN); b.
- •Total bilirubin <= 1.5 × ULN or 3.0 × ULN and primarily unconjugated if patient
- •has a documented history of Gilbert*s syndrome or a genetic equivalent; 7.
- •Laboratory measurements, renal function: Serum creatinine <= 1.5 × ULN or
- •calculated glomerular filtration rate (GFR) >30 mL/min/1.73 m2 (calculated with
- •CKD-EPI formula); 8. Females of childbearing potential must be willing to use a
- •highly effective method of contraception during the study and for 12 months
- •after the last dose of rituximab or for 6 months after the last dose of
- •BYON4228, whichever takes longer; 9. Part 1: Willing to consent to 1
- •pre-treatment tumor biopsy. If a recent (<= 2 months) archival tumor biopsy
- •sample is available prior to signing the ICF and the patient did not have
- •anticancer treatment (including steroids) since the biopsy was performed, this
- •could be used as the pre-treatment tumor biopsy; 10. Part 2: Willing to consent
- •to 1 pre-treatment and 1 on-treatment tumor biopsy. If a recent (<= 2 months)
- •archival tumor biopsy sample is available prior to signing the ICF and the
- •patient did not have anticancer treatment (including steroids) since the biopsy
- •was performed, this could be used as the pre-treatment tumor biopsy.
排除标准
- •1. Having been treated with:
- •a. CD47 or SIRPa targeting agents at any time;
- •b. Other anticancer therapy including investigational agents within 2
- •weeks prior to start of BYON4228 treatment or within 4 times the
- •elimination half-life (up to a maximum of 4 weeks) whichever is longer.
- •Note: treatment with hormonal therapy with LHRH agonists for localized prostate
- •cancer, and treatment with bisphosphonates and RANKL inhibitors are not
- •criteria for exclusion;
- •c. Radiotherapy within 1 week prior to start of BYON4228;
- •d. Autologous HSCT or CAR-T cell therapy within 3 months prior to start IMP, or
- •allogeneic HSCT within 6 months prior to start IMP.
- •In addition, the patient must have sufficiently recovered from any
- •treatment-related toxicities or CTCAE Grade <= 1 or baseline, except for
- •toxicities not considered a safety risk for the patient at the investigator's
- •discretion;
- •2. Any contraindication to rituximab treatment;
- •3. History of hypersensitivity or allergic reaction to any of the excipients of
- •BYON4228 or rituximab which led to permanent discontinuation of the treatment;
- •4. Currently diagnosed or suspected CNS involvement;
- •5. Burkitt's lymphoma;
- •6. Known active or chronic (DNA or RNA positive) hepatitis B, C or E
- •infection or human immunodeficiency virus (HIV);
- •7. Red blood cell (RBC) transfusion dependence, defined as requiring
- •more than 2 units of RBC transfusions during the 4-week period prior to
- •8. Patients with active graft versus host disease (GVHD) or ongoing
- •immunosuppression for GVHD;
- •9. History of autoimmune hemolytic anemia or autoimmune
- •thrombocytopenia that in the investigator's opinion is likely to
- •jeopardize patient safety;
- •10. History of autoimmune disorders (including but not limited to:
- •Crohn's disease, rheumatoid arthritis, scleroderma, systemic lupus
- •erythematosus, Grave's disease) or other conditions that compromise or impair
- •the immune system (except for hypogammaglobulinemia) and that in the
- •investigator's opinion is likely to jeopardize patient safety;
- •11. Second malignancy, other than the one treated in this trial, in the
- •last 3 years before signing ICF. Except, if appropriately treated: basal
- •cell or localized squamous skin carcinomas, localized prostate cancer or
- •localized cervical cancer. Any other indolent malignancy may be allowed upon
- •discussion with the medical monitor;
- •12. History (within 6 months prior to start of BYON4228 treatment) or
- •presence of clinically significant cardiovascular disease such as unstable
- •angina, congestive heart failure, myocardial infarction, uncontrolled
- •hypertension, or cardiac arrhythmia requiring medication. Presence of atrial
- •fibrilation may be allowed upon discussion with the medical monitor;
- •13. Severe active infection or other severe uncontrolled systemic disease
- •(e.g., advanced renal disease, pulmonary, uncontrolled diabetes mellitus,
- •severely immunocompromised state, or metabolic disease) at screening;
- •14. Major surgery within 4 weeks prior to start of BYON4228 treatment;
- •15. Pregnancy or active breastfeeding;
- •16. Other condition that in the investigator's opinion is likely to
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