EUCTR2018-000264-28-ES进行中（未招募）1 期
A Phase 2, Multi-cohort, Open-label, Multi-center Study to Determine the Efficacy and Safety of bb2121 in Subjects with Relapsed and Refractory Multiple Myeloma and in Subjects With High-Risk Multiple Myeloma Having Progressed Within One Year of Initial Treatment (KarMMa-2)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 122
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
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 HR and 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:
- •- R-ISS stage III
- •- Early relapse defined as:
- •- For subjects that have undergone transplant, PD < 12 months since date of first transplant
- •- For subjects that have received only induction, PD < 12 months since date of last treatment regimen which must contain at minimum, a proteasome inhibitor, an immunomodulatory agent and dexamethasone
- •4. Subject must have Eastern Cooperative Oncology Group (ECOG) performance status = 1
- •5. Subject must have recovery to Grade 1 or baseline of any non-hematologic 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
- •9. Female subjects of childbearing potential (FCBP) must:
- •Have a negative pregnancy test as verified by the Investigator, one negative serum beta human chorionic gonadotropin (ß-hCG) pregnancy test result at screening, prior to LD chemotherapy. This applies even if the subject practices true abstinence* from heterosexual contact
- •Either commit to true abstinence from heterosexual contact or agree to use, and be able to comply with, effective measures of contraception w
排除标准
- •1. Subject used any investigational agents within 28 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 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. (Note: Only if subject experienced Grade 4 neurotoxicity following bb2121 treatment is this exclusion criteria applicable before retreatment with bb2121 (Cohort 1)
- •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
研究者
相似试验
进行中（未招募）
1 期
A study to assess the efficacy and safety of bb2121 in people who have Myeloma that is not responsive after treatment or who had Myeloma which has returned after a period of treatment.EUCTR2018-000264-28-FRCelgene Corporation122
进行中（未招募）
1 期
A study to assess the efficacy and safety of bb2121 in people who have Myeloma that is not responsive after treatment or who had Myeloma which has returned after a period of treatment.Relapsed and refractory multiple myeloma (RRMM), multiple myeloma (MM) with progression within 18 months of initial treatment, or MM with inadequate response post autologous stem cell transplant (ASCT) during initial treatment.MedDRA version: 16.1Level: HLTClassification code 10028229Term: Multiple myelomasSystem Organ Class: 100000004851MedDRA version: 21.1Level: LLTClassification code 10067095Term: Multiple myeloma progressionSystem Organ Class: 100000004864EUCTR2018-000264-28-DECelgene Corporation181
进行中（未招募）
1 期
A study to evaluate the safety and efficacy of CC-90011 in combination with nivolumab in subjects with advanced cancers.Small cell lung cancer (SCLC) and squamous non-small cell lung cancer (sqNSCLC)MedDRA version: 21.1Level: LLTClassification code 10041071Term: Small cell lung cancer stage unspecifiedSystem Organ Class: 100000004864MedDRA version: 21.1Level: LLTClassification code 10029514Term: Non-small cell lung cancer NOSSystem Organ Class: 100000004864MedDRA version: 21.1Level: LLTClassification code 10025126Term: Lung squamous cell carcinoma stage unspecifiedSystem Organ Class: 100000004864EUCTR2019-004194-95-ITCELGENE CORPORATIO135
进行中（未招募）
1 期
A study to evaluate the safety and efficacy of CC-90011 in combination with nivolumab in subjects with advanced cancers.Small cell lung cancer (SCLC) and squamous non-small cell lung cancer (sqNSCLC)MedDRA version: 21.1Level: LLTClassification code 10041071Term: Small cell lung cancer stage unspecifiedSystem Organ Class: 100000004864MedDRA version: 21.1Level: LLTClassification code 10029514Term: Non-small cell lung cancer NOSSystem Organ Class: 100000004864MedDRA version: 21.1Level: LLTClassification code 10025126Term: Lung squamous cell carcinoma stage unspecifiedSystem Organ Class: 100000004864EUCTR2019-004194-95-GBCelgene Corporation135
进行中（未招募）
1 期
A study to evaluate the safety and efficacy of CC-90011 in combination with nivolumab in subjects with advanced cancers.Small cell lung cancer (SCLC) and squamous non-small cell lung cancer (sqNSCLC)MedDRA version: 21.1Level: LLTClassification code 10041071Term: Small cell lung cancer stage unspecifiedSystem Organ Class: 100000004864MedDRA version: 21.1Level: LLTClassification code 10029514Term: Non-small cell lung cancer NOSSystem Organ Class: 100000004864MedDRA version: 21.1Level: LLTClassification code 10025126Term: Lung squamous cell carcinoma stage unspecifiedSystem Organ Class: 100000004864EUCTR2019-004194-95-FRCelgene Corporation135