The Safety and Efficacy of Universal CAR-T Cells Targeting BCMA in the Treatment of Refractory NMOSD

Launched by BIORAY LABORATORIES · Oct 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for a condition called refractory NMOSD, which is an autoimmune disease that affects the nervous system. The researchers want to see if using universal CAR-T cells that target a specific protein (BCMA) can be safe and effective for people who have not responded well to existing treatments. The trial will involve up to 18 participants and will be conducted at multiple locations.

To be eligible for this trial, participants should be between 18 and 65 years old and must have been diagnosed with refractory NMOSD. They should also expect to live for at least 12 weeks as determined by the study team. Additionally, participants will need to agree to use effective birth control methods during the study and for a year afterward. The trial is not yet recruiting, so individuals interested in participating should keep an eye out for updates. It’s important to note that certain health conditions, like a history of organ transplantation or severe allergies, may prevent someone from joining. If eligible, participants will receive the new treatment and will be closely monitored for safety and effectiveness throughout the study.

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Eligibility criteria

• Inclusion Criteria:
• • Aged 18-65 years ; both genders eligible.
• • Meets the criteria for Refractory NMOSD.
• • Anticipated survival of ≥ 12 weeks as judged by the researcher.
• • Agrees to use double barrier methods, condoms, oral or injectable contraceptives, or intrauterine devices during the study period and for one year after taking the study medication.
• • Provides written informed consent.
• Exclusion Criteria:
• • History of solid organ transplantation.
• • Malignant tumor within the last two years.
• • Positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb), with peripheral blood Hepatitis B virus (HBV) DNA detected as positive; positive for Hepatitis C virus antibodies, with peripheral blood Hepatitis C virus RNA detected as positive; positive for Human Immunodeficiency Virus (HIV) antibodies; positive for Cytomegalovirus (CMV) DNA; positive for syphilis.
• • Primary immunodeficiency (congenital or acquired).
• • Severe cardiac disease.
• • History of psychiatric disorders or history of psychotropic drug abuse, with no history of withdrawal.
• • Allergic constitution or a history of severe allergies.
• • Pregnant or breastfeeding women.