Multiple Myeloma Clinical Trial
Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma
Summary
This is an open label, single-arm, multicenter, Phase 2 study to evaluate the efficacy and safety of bb2121 in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture bb2121 chimeric antigen receptor (CAR) modified T cells. Prior to bb2121 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.
Full Description
Anti-myeloma bridging treatment is allowed for disease control while bb2121 is being manufactured.
Eligibility Criteria
Inclusion Criteria:
Eligibility is determined prior to leukapheresis. Subjects must satisfy the following criteria to be enrolled in the study:
Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).
Documented diagnosis of multiple myeloma
Must have received at least 3 prior MM treatment regimens. Note: induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single regimen.
Must have undergone at least 2 consecutive cycles of treatment for each regimen, unless PD was the best response to the regimen.
Must have received a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody.
Must be refractory to the last treatment regimen.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Subjects must have measurable disease, including at least one of the criteria below:
Serum M-protein greater or equal to 1.0 g/dL
Urine M-protein greater or equal to 200 mg/24 h
Serum free light chain (FLC) assay: involved FLC level greater or equal to 10 mg/dL (100 mg/L) provided serum FLC ratio is abnormal
Recovery to Grade 1 or baseline of any non-hematologic toxicities due to prior treatments, excluding alopecia and Grade 2 neuropathy.
Exclusion Criteria:
The presence of any of the following will exclude a subject from enrollment:
Subjects with known central nervous system involvement with myeloma.
History or presence of clinically relevant central nervous system (CNS) pathology.
Subjects with active or history of plasma cell leukemia.
Subjects with solitary plasmacytomas or non-secretory myeloma without other evidence of measurable disease
Inadequate organ function
Ongoing treatment with chronic immunosuppressants
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
Evidence of human immunodeficiency virus (HIV) infection.
Seropositive for and with evidence of active viral infection with hepatitis B virus (HBV)
Seropositive for and with evidence of active viral infection with hepatitis B virus (HBV) and Hepatitis C virus (HCV)
Subjects with a history of class III or IV congestive heart failure (CHF) or severe non-ischemic cardiomyopathy, history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia within the previous 6 months.
Subjects with second malignancies in addition to myeloma if the second malignancy has required therapy in the last 3 years or is not in complete remission
Pregnant or lactating women.
Subject with known hypersensitivity to any component of bb2121 productThe presence of any of the following will exclude a subject from enrollment:
1. Subjects with known central nervous system involvement with myeloma. 2. History or presence of clinically relevant central nervous system (CNS) pathology.
3. Subjects with active or history of plasma cell leukemia. 4. Subjects with solitary plasmacytomas or non-secretory myeloma without other evidence of measurable disease 5. Inadequate organ function 6. Ongoing treatment with chronic immunosuppressants 7. 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 8. Evidence of human immunodeficiency virus (HIV) infection. 9. Seropositive for and with evidence of active viral infection with hepatitis B virus (HBV) and Hepatitis C virus (HCV) 10. Subjects with a history of class III or IV congestive heart failure (CHF) or severe non-ischemic cardiomyopathy, history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia within the previous 6 months. 11. Subjects with second malignancies in addition to myeloma if the second malignancy has required therapy in the last 3 years or is not in complete remission 12. Pregnant or lactating women. 13 Subject with known hypersensitivity to any component of bb2121 product, cyclophosphamide, fludarabine, or tocilizumab.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 24 Locations for this study
San Francisco California, 94143, United States
Atlanta Georgia, 30322, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Rochester Minnesota, 55905, United States
Hackensack New Jersey, 07601, United States
New York New York, 10029, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75390, United States
Leuven , B-300, Belgium
Toronto Ontario, M5G 2, Canada
Lille , 59037, France
Nantes , 44093, France
Heidelberg , 69120, Germany
Tübingen , 72076, Germany
Würzburg , 97080, Germany
Bergamo , 24128, Italy
Bologna , 40138, Italy
Isehara City, Kanagawa , 259-1, Japan
Shibuya-ku , 150-8, Japan
Shimotsuke , 329-0, Japan
Shinjuku City , 162-8, Japan
Badalona (Barcelona) , 08916, Spain
Pamplona , 31008, Spain
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.