Letetresgene Autoleucel Engineered T Cells Alone and in Combination With Pembrolizumab in NY-ESO-1 Positive Multiple Myeloma

Exclusion Criteria

• •Has only plasmacytomas, plasma cell leukemia, monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), non-secretory myeloma or primarily amyloidosis.
• •Previously received anti- programmed death (PD)-1, anti-PD-ligand (L)1, or anti-PD-L2 inhibitor.
• •Previously participated in Merck pivotal trial NCT02576977: Study of Pomalidomide and Low Dose Dexamethasone With or Without Pembrolizumab in Refractory or RRMM.
• •Had a prior allogeneic stem cell transplant.
• •Has ongoing toxicity from previous anticancer therapy.
• •Had a major surgery within 4 weeks prior to enrollment.
• •Has history of allergic reactions to fludarabine, cyclophosphamide or agents similar to fludarabine, cyclophosphamide or other agents used in the study.
• •Known history of myelodysplasia.
• •Current active liver or biliary disease.
• •Known history of chronic active hepatitis or liver cirrhosis.
• •Participant has an active viral infection.
• •History of severe immune disease, including non-infectious pneumonitis, requiring steroids or other immunosuppressive treatments.
• •Active immune-mediated diseases.
• •Prior or active demyelinating disease.
• •Evidence or history of significant cardiac disease.
• •Evidence or history of other significant, hepatic, renal, ophthalmologic, psychiatric, or gastrointestinal disease.
• •Participants with concomitant second malignancies (except adequately treated non-melanomatous skin cancers, carcinoma in situ of the breast, treated superficial bladder cancer or prostate cancer, or in situ cervical cancers ) not in complete remission.
• •Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may be eligible.
• •Active bacterial or systemic viral or fungal infections.
• •Pregnant or breastfeeding.
• •Cannot meet washout periods for prior radiotherapy, chemotherapy or other protocol-specified therapies.
• •More than 2 years have passed since the participant's last leukapheresis collection.