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

Launched by ORICELL THERAPEUTICS CO., LTD. · Feb 14, 2024

Keywords

ClinConnect Summary

The RIGEL Study is a clinical trial designed to test a new treatment called OriCAR-017 for patients with relapsed or refractory multiple myeloma, which is a type of blood cancer. This is the first study of its kind in the U.S. and aims to evaluate how safe the treatment is, how the body processes it, and whether it shows any early signs of effectiveness. The study is currently looking for participants aged 18 to 75 who have had at least three previous treatments for their condition and have specific levels of proteins in their blood or urine that indicate the presence of multiple myeloma.

Participants in the trial will receive the OriCAR-017 treatment and will be closely monitored for any side effects and how well the treatment works. It’s important for potential participants to know that they will need to meet certain health criteria and cannot be pregnant or breastfeeding. Individuals who have had recent stem cell treatments or certain infections will also not be eligible. Overall, this study offers a chance to explore a promising new therapy for those who have not responded to other treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • Pregnant or breastfeeding.
• • Seropositive for history of human immunodeficiency virus Active Hepatitis B infection and or Hepatitis C infection
• • Known active or prior history of CNS involvement
• • 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
• • 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.
• • Any condition that in the opinion of the Investigator, would interfere with evaluation of the IMP.
• • Received Bendamustine treatment 1 year prior to Screening Visit.