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 accepting patients for this trial.

Lead Sponsor:

Celgene

Collaborator: bluebird bio

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

   - 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

   - Subjects must have measurable disease

   - Women of child-bearing potential (WCBP) must have a negative serum pregnancy test
   prior to treatment. All sexually active WCBP and all sexually active male subjects
   must agree to use effective methods of birth control throughout the study

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

   - Subjects with a history of stroke, unstable angina, myocardial infarction, or
   ventricular arrhythmia requiring medication or mechanical control

   - 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

   - Known human immunodeficiency virus (HIV) positivity

   - Subjects with a history of stroke, unstable angina, myocardial infarction, or
   ventricular arrhythmia requiring medication or mechanical control

   - Pregnant or lactating women

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Reneth Tien
650-723-0646
Recruiting