:
The presence of any of the following will exclude a subject from enrollment:
1. Subject used any investigational agents within 14 days prior to leukapheresis or, for
Cohort 3, within 14 days prior to consent
2. Subject received any of the following within the last 14 days prior to leukapheresis
or, for Cohort 3, within 14 days prior to consent:
1. Plasmapheresis
2. Major surgery (as defined by the investigator)
3. Radiation therapy other than local therapy for myeloma associated bone lesions
4. Use of any systemic anti-myeloma drug therapy
3. Subject with known central nervous system involvement with myeloma
4. Subject has clinical evidence of pulmonary leukostasis and disseminated intravascular
coagulation
5. History or presence of clinically relevant central nervous system (CNS) pathology
6. Subject with active or history of plasma cell leukemia, Waldenstrom's
macroglobulinemia, POEMS syndrome, or clinically significant amyloidosis
7. Inadequate organ function 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
8. Ongoing treatment with chronic immunosuppressants
9. 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
10. Subject has received ASCT within 12 weeks prior to leukapheresis
11. Subject has history of primary immunodeficiency
12. Subject is positive for human immunodeficiency virus (HIV-1), chronic or active
hepatitis B or active hepatitis A or C
13. Subject has uncontrolled systemic fungal, bacterial, viral or other infection
(including tuberculosis) despite appropriate antibiotics or other treatment
14. Subject with prior history of malignancies, other than MM, unless the subject has been
free of the disease for ≥ 5 years
15. Pregnant or lactating women
16. Subject with known hypersensitivity to any component of bb2121 product,
cyclophosphamide, fludarabine, and/or tocilizumab
17. Prior history of deep venous thrombosis (DVT) or pulmonary embolus (PE) within 6
months prior to consent (For Cohort 3)
18. For Cohort 1b, previous treatment with any G Protein-Coupled Receptor Class C Group 5
Member D (GPRC5D) targeted therapy or T-cell engagers
19. For Cohort 1b, known allergies, hypersensitivity, or intolerance to talquetamab or its
excipients
Recruiting
