A Phase 2, Multicohort, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of bb2121 in Subjects with Relapsed and Refractory Multiple Myeloma and in Subjects With Clinical High-Risk Multiple Myeloma (KarMMa-2) - n.a.

CELGENE CORPORATIO0 个研究点目标入组 181 人开始时间: 2021年6月15日最近更新: 2021年8月30日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 181

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1. Subject is = 18 years of age at the time of signing the informed consent form (ICF)
•2. Subject has measurable disease, defined as:
•M-protein (serum protein electrophoresis [sPEP] or urine protein electrophoresis [uPEP]): sPEP = 0.5 g/dL or uPEP = 200 mg/24 hours and/or
•Light chain MM without measurable disease in the serum or urine: Serum immunoglobulin free light chain = 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio
•3. Subjects with one of the following cohort specific requirements: Cohort 1 RRMM subjects with = 3 prior anti-myeloma treatment regimens:
•Subject must have received at least 3 prior anti-myeloma treatment regimens. Note: induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single regimen
•Subject must have undergone at least 2 consecutive cycles of treatment for each regimen, unless PD was the best response to the regimen
•Subject must have received prior treatment with a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody
•Subject has evidence of PD on or within 60 days of the most recent prior treatment regimen
•Subject achieved a response (minimal response [MR] or better) to at least 1 prior treatment regimen
•Cohort 2 subjects with 1 prior anti-myeloma treatment regimen:
•Subject must have received only 1 prior anti-myeloma treatment regimen. Note: induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single regimen
•Subject must have the following HR factors:
•Early relapse defined as:
•¿ Cohort 2a: PD < 18 months since date of start of initial therapy. Initial therapy must contain induction, ASCT (single or tandem) and LEN containing maintenance
•¿ Cohort 2b: PD < 18 months since date of start of initial therapy which must contain at minimum, a proteasome inhibitor, an immunomodulatory agent and dexamethasone
•¿ Cohort 2c: Subject must have received minimum 3 cycles of induction therapy which must contain at minimum, a proteasome inhibitor, an immunomodulatory agent and dexamethasone. Subjects must have had ASCT (single or tandem)
•< VGPR (excluding PD) at first assessment between 70 to 110 days after last ASCT, with initial therapy without consolidation and maintenance
•4. Subject must have Eastern Cooperative Oncology Group (ECOG) performance status = 1
•5. Subject must have recovery to Grade 1 or baseline of any nonhematologic toxicities due to prior treatments, excluding alopecia and Grade 2 neuropathy
•6. Subject must have adequate vascular access for leukapheresis
•7. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted
•8. Subject is willing and able to adhere to the study visit schedule and other protocol requirements as well as agrees to continued follow up for up to 15 years as mandated by the regulatory guidelines for gene therapy trials
•For the complete list of Inclusion Criteria, please refer to section 4.2. Inclusion Criteria” of Protocol version Final of 19Jun2018.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 108
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 73

排除标准

•1. Subject used any investigational agents within 14 days of leukapheresis
•2. Subject received any of the following within the last 14 days of leukapheresis:
•a. Plasmapheresis
•b. Major surgery (as defined by the investigator)
•c. Radiation therapy other than local therapy for myeloma associated bone lesions
•d. Use of any systemic anti-myeloma drug therapy
•3. Subject with known central nervous system (CNS) involvement with myeloma
•4. Subject has clinical evidence of pulmonary leukostasis and disseminated intravascular coagulation
•5. History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, subarachnoid hemorrhage or other CNS bleed, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
•6. Subject with active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or clinically significant amyloidosis
•7. Subject has nonsecretory MM
•8. Subject has any of the following laboratory abnormalities:
•a. Absolute neutrophil count (ANC) < 1,000/µL
•b. Platelet count < 50,000 mm3 in the absence of transfusion support (platelet transfusion within 7 days of screening)
•c. Hemoglobin < 8 g/dL (< 4.9 mmol/L) (it is not permissible to transfuse a subject to reach this level)
•d. Serum Creatinine Clearance (CrCl) < 45 mL/min
•e. Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L)
•f. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 × upper limit of normal (ULN)
•g. Serum total bilirubin > 1.5 × ULN or > 3.0 mg/dL for subjects with documented Gilbert's syndrome
•h. International ratio (INR) or partial thromboplastin time (PTT) > 1.5 × ULN, or history of Grade = 2 hemorrhage within 30 days, or subject requires ongoing treatment with chronic, therapeutic dosing of anticoagulants (eg, warfarin, low molecular weight heparin, Factor Xa inhibitors)
•9. Echocardiogram (ECHO) or multi-gated acquisition (MUGA) with left ventricular ejection fraction < 45%
•10. Subject with a history of Class III or IV congestive heart failure (CHF) or severe nonischemic cardiomyopathy, unstable or poorly controlled angina, myocardial infarction, or ventricular arrhythmia within the previous 6 months prior to starting study treatment
•11. Inadequate pulmonary function defined as oxygen saturation (Sa02) < 92 % on room air
•12. Ongoing treatment with chronic immunosuppressants (eg, cyclosporine or systemic steroids at any dose). Intermittent topical, inhaled or intranasal corticosteroids are allowed
•13. Previous history of an allogeneic hematopoietic stem cell transplantation or treatment with any gene therapy-based therapeutic for cancer or investigational cellular therapy for cancer or BCMA targeted therapy
•14. Subject has received ASCT within 12 weeks prior to leukapheresis
•15. Subject has history of primary immunodeficiency
•16. Subject is positive for human immunodeficiency virus (HIV-1), chronic or active hepatitis B or active hepatitis A or C
•For the complete list of Exclusion Criteria, please refer to section 4.2. Exclusion Criteria” of Protocol version Final of 19Jun2018.

研究者

发起方

CELGENE CORPORATIO

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