A Study to Evaluate the Safety, PK/PD of (OriCAR-017) in Subjects With RR/MM - RIGEL Study

Korábbi kezelés

• Known active or prior history of CNS involvement
• Subjects who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks of Screening Visit or who plan to undergo ASCT during the study.
• Subjects who received allogeneic stem cell therapy.
• Received Bendamustine treatment 1 year prior to Screening Visit.

Más betegség

• Seropositive for history of human immunodeficiency virus Active Hepatitis B infection and or Hepatitis C infection
• History of autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) caused damage to terminal organs or required systemic application of immunosuppressive or other drugs in the past 2 years
• Presence of uncontrolled active infection
• Any condition that in the opinion of the Investigator, would interfere with evaluation of the IMP.

Egyéb

• Pregnant or breastfeeding.

• Capable of giving signed informed consent
• Subjects aged 18 to 75 years (inclusive) at Screening (signing the ICF).
• Expected survival period is >12 weeks.
• Diagnosis of MM according to the IMWG criteria (2016 version).
• One of the following criteria must be met:
• If immunoglobulin (Ig)G type MM, then serum M protein >10 g/L; if IgA, IgD, IgE or IgM type MM, then serum M protein >5 g/L
• Urine M protein level >200 mg/24 hour
• If light chain type MM, then serum free light chain (sFLC) >100 mg/L and K/λ FLC ratio is abnormal.
• Extramedullary lesions (>1 cm for diameter of the short axis).
• For Phase I (dose-escalation) - Subjects who had received at least 3 prior lines of therapy, had previous exposure to BCMA-Ag+ therapies, and were refractory to the last line of therapy.
• For Phase I (dose-expansion) and Phase II: Subjects with previous exposure to BCMA directed therapies including BCMA bispecific antibody (e.g., teclistamab), BCMA antibody directed conjugate (such as BLENREP), and BCMA-CAR-T (such as CARVYKT1TM)
• Subjects with adequate hematologic, renal, hepatic, pulmonary and cardiac function.
• Subject and partners willing to take and or use effective contraceptive measures until 2 years post IMP infusion.