Trial Search Results

Study of bb2121 in Multiple Myeloma

The sponsor of this study, bluebird bio, Inc. is studying a possible treatment for multiple myeloma using an investigational treatment called "gene transfer". This clinical study will involve taking some of your white blood cells (T cells), and modifying them with a gene transfer agent in order to target BCMA on your cancer cells. Using gene transfer, it is expected that your T cells will be modified to allow them to identify and kill cells that have the protein BCMA on the surface of the cell. These modified T cells are called Chimeric Antigen Receptor (CAR) T cells.

The purpose of this study is to evaluate if gene transfer as described above is a safe and tolerable way to treat your multiple myeloma. The study will also evaluate how well the investigational T cells kill your tumor cells.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Celgene

Collaborator: bluebird bio

Stanford Investigator(s):

Intervention(s):

  • Biological: bb2121

Phase:

Phase 1

Eligibility


Inclusion Criteria:

   - 18 years of age at the time of signing informed consent

   - 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 0.5 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 -Women of child-bearing potential (WCBP) must
have a negative serum pregnancy test prior to treatment and refrain from tissue donation
including egg donation or any other tissue/blood/organ donations, for at least 1 year
following bb2121 infusion. All sexually active WCBP and all sexually active male subjects
must agree to use effective methods of birth control throughout the study. All sexually
active males subjects must refrain from tissue donation including egg donation or any other
tissue/blood/organ donations, for at least 1 year following bb2121 infusion.

Part A:

Diagnosis of MM with relapsed or refractory disease and have had at least 3 different prior
lines of therapy including proteasome inhibitor (e.g., bortezomib or carfilzomib) and
immunomodulatory therapy (IMiD; e.g., lenalidomide or pomalidomide), or have "double
refractory" disease to a proteasome inhibitor and IMiD, defined as progression on or within
60 days of treatment with these agents

- Part B: Diagnosis of MM with relapsed or refractory disease with previous exposure to PI
(e.g., bortezomib or carfilzomib), IMiDs (e.g., lenalidomide or pomalidomide), and
daratumumab, and refractory (based on IMWG criteria) to their last line of therapy

Exclusion Criteria:

   - Subjects with known central nervous system disease

   - Inadequate hepatic function

   - Inadequate renal function

   - Inadequate bone marrow function

   - Presence of active infection within 72 hours

   - Significant co-morbid condition or disease which in the judgment of the Investigator
   would place the subject at undue risk or interfere with the study; examples include,
   but are not limited to, cirrhotic liver disease, sepsis, recent significant traumatic
   injury, and other conditions

   - 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

   - Subjects with a history of class III or IV congestive heart failure or non-ischemic
   cardiomyopathy, unstable angina, myocardial infarction, or ventricular arrhythmia
   requiring medication or mechanical control within the previous 6 months

   - Known human immunodeficiency virus (HIV) positivity

   - Subjects who have plasma cell leukemia or clinically significant amyloidosis

   - Pregnant or lactating women

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting