Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma (KarMMa)
a study on Multiple Myeloma
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.
A Phase 2, Multicenter Study to Determine the Efficacy and Safety of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma
Anti-myeloma bridging treatment is allowed for disease control while bb2121 is being manufactured.
Multiple Myeloma Efficacy and Safety BB2121 CAR T Cell BCMA Relapsed and Refractory Neoplasms, Plasma Cell
You can join if…
Open to people ages 18 years and up
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
You CAN'T join if...
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 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 product
- University of California - San Francisco accepting new patients
San Francisco, California, 94143, United States
- University of Texas Southwestern Medical Center accepting new patients
Dallas, Texas, 75390, United States
- Mayo Clinic accepting new patients
Rochester, Minnesota, 55905, United States
- Sarah Cannon Research Institute accepting new patients
Nashville, Tennessee, 37203, United States
- Emory University accepting new patients
Atlanta, Georgia, 30322, United States
- Hackensack University Medical Center accepting new patients
Hackensack, New Jersey, 07601, United States
- Mt. Sinai Medical Center accepting new patients
New York, New York, 10029, United States
- accepting new patients
- Start Date
- Completion Date
- Phase 2
- Study Type
- Last Updated
- March 1, 2018
Please contact me about this study
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
The study team should get back to you in a few business days.
You will also receive an email with next steps. Check your junk/spam folder if needed.
If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT03361748.