MCARH109 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of Multiple Myeloma

Exclusion Criteria

• •Pregnant or lactating women. Women and men of childbearing age should use highly effective contraception while on this study and continue for 1 year after all treatment is finished.
• •Patients with following cardiac conditions will be excluded:
• •* New York Heart Association (NYHA) stage III or IV congestive heart failure
• •* Myocardial infarction ≤6 months prior to enrollment
• •* History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration
• •* History of severe non-ischemic cardiomyopathy
• •Patients with HIV or active hepatitis B or hepatitis C infection are ineligible.
• •Current diagnosis of primary and secondary plasma cell leukemia is excluded. History of plasma cell leukemia is not excluded.
• •Patients who have not received any myeloma therapy for the preceding 6 months, except if the last myeloma therapy was a CAR T cell therapy.
• •At least 14 day washout from myeloma therapies prior to leukapheresis and prior to starting lymphodepletion. The washout for experimental treatments would be 5 half lives or 14 days (whichever is shorter).
• •At least 14 day washout from radiation prior to leukapheresis and prior to starting lymphodepletion.
• •Patients treated with previous GPRC5D targeted therapies would be excluded.
• •Patients with any concurrent active malignancies (or another primary malignancy not in remission for at least 2 years) as defined by malignancies requiring any therapy other than expectant observation or hormonal therapy, with the exception of squamous and basal cell carcinoma of skin.
• •Patients with a prior allogeneic transplant at least 6 months prior to study enrollment ARE eligible UNLESS experienced GvHD that required systemic steroids or other systemic lymphotoxic therapy within 12 weeks of initial screening
• •Patients on systemic steroids (except if solely for adrenal replacement) within two weeks of collection
• •Active auto-immune disease including connective tissue disease, uveitis, sarcoidosis, inflammatory bowel disease, or multiple sclerosis, or have a history of severe (as judged by the principal investigator) autoimmune disease requiring prolonged immunosuppressive therapy
• •Prior or active CNS involvement by myeloma (e.g. leptomeningeal disease). Screening for this, for example, by lumbar puncture, is only required if suspicious symptoms or radiographic findings are present.
• •Pre-existing (active or severe) neurologic disorders (e.g. pre-existing seizure disorder)
• •Active uncontrolled acute infections
• •Any other issue which, in the opinion of the treating physician, would make the patient ineligible for the study.