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
- Conditions
- Relapsed and refractory multiple myeloma (RRMM), multiple myeloma(MM) with progression within 18 months of initial treatment/ or newlydiagnosed multiple myeloma (NDMM) with suboptimal response postautologous stem cell transplant (ASCT) (Cohort 3 only)MedDRA version: 16.1Level: HLTClassification code: 10028229Term: Multiple myelomas Class: 10029104MedDRA version: 21.1Level: LLTClassification code: 10067095Term: Multiple myeloma progression Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-505183-10-00
- Lead Sponsor
- Celgene Corp.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 235
Subject is = 18 years of age at the time of signing the informed consent form (ICF), Male subjects must: • Practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a FCBP, even if he has undergone a successful vasectomy from screening until at least 1 year following LD chemotherapy • Refrain from tissue donation including sperm or any other tissue/blood/organ donations from screening until at least 1 year following LD chemotherapy., Cohorts 1 and 2 only, 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, 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 lenalidomide 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) AND < VGPR (excluding PD) at first assessment between 70 to 110 days after last ASCT, with initial therapy without consolidation and maintenance, Subject must have Eastern Cooperative Oncology Group (ECOG) performance status = 1, Subject must have recovery to Grade 1 or baseline of any nonhematologic toxicities due to prior treatments, excluding alopecia and Grade 2 neuropathy, Subject must have adequate vascular access for leukapheresis, Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted, 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, Female subjects of childbearing potential (FCBP3) must: • Have a negative pregnancy test(s) as verified by the Investigat
Subject used any investigational agents within 14 days prior to leukapheresis., 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., Inadequate pulmonary function defined as oxygen saturation (Sa02) < 92 % on room air., Ongoing treatment with chronic immunosuppressants (eg, cyclosporine or systemic steroids at any dose). Intermittent topical, inhaled or intranasal corticosteroids are allowed., 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., Subject has received ASCT within 12 weeks prior to leukapheresis., Subject has history of primary immunodeficiency., Subject is positive for human immunodeficiency virus (HIV-1), chronic or active hepatitis B or active hepatitis A or C., Subject has uncontrolled systemic fungal, bacterial, viral or other infection (including tuberculosis) despite appropriate antibiotics or other treatment., Subject with prior history of malignancies, other than MM, unless the subject has been free of the disease for = 5 years with the exception of the following noninvasive malignancies: a. Basal cell carcinoma of the skin b. Squamous cell carcinoma of the skin c. Carcinoma in situ of the cervix d. Carcinoma in situ of the breast e. Incidental histologic finding of prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system) or prostate cancer that is curative., Subject is a female who is pregnant, nursing, or breastfeeding, or who intends to become pregnant during participation in the study., Subject received any of the following within the last 14 days prior to 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., Subject with known hypersensitivity to any component of bb2121 product, cyclophosphamide, fludarabine, and/or tocilizumab., Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study., Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study. This includes systemic fungal, bacterial, viral, or other infection that is uncontrolled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antimicrobial treatment) or requiring IV antimicrobials for management., Subject has any condition that confounds the ability to interpret data from the study., Subject with known central nervous system (CNS) involvement with myeloma., Subject has clinical evidence of pulmonary leukostasis and disseminated intravascular coagulation., 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., Subject with active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyne
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method