Autologous CD19 Car T-Cell Therapy For Severe Refractory Systemic Lupus Erythematosus (SLE)

Launched by NATIONAL UNIVERSITY OF MALAYSIA · Nov 26, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called autologous CD19 CAR T-cell therapy for patients with severe systemic lupus erythematosus (SLE), which is a serious autoimmune disease where the immune system mistakenly attacks the body's own tissues. Many current treatments do not work well for everyone and can have significant side effects, so researchers are exploring this innovative approach to see if it can help those whose SLE has not responded to standard therapies.

To participate in this trial, individuals must be between 18 and 65 years old and have a confirmed diagnosis of SLE that is not well-controlled despite trying at least two different treatments for at least three months. Participants will be closely monitored throughout the study, and the trial is currently not yet recruiting patients. It's important to note that certain health conditions, such as active cancer or severe heart and lung problems, may exclude someone from participating. This trial represents an exciting opportunity for patients with severe SLE to potentially gain access to a new form of treatment that could improve their health and quality of life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
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• • Aged between ≥ 18 to ≤ 65 years Clinical Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria (Fanouriakis et al., 2019) Positive anti-nuclear antibody (ANA) (titer ≥1:80 ), anti-dsDNA (≥30 IU/mL on enzyme-linked immunosorbent assay \[ELISA\]), or anti-Smith at screening or by documented medical history Active disease (defined by not being in remission according to DORIS criteria or in a low disease activity state \[LLDAS\]) (Franklyn et al., 2016, van Vollenhoven et al., 2021) With at least one active organ system involvement Persistent active disease with insufficient response to glucocorticoids and at least 2 of the following treatments for at least 3 months each: cyclophosphamide, mycophenolate mofetil or its derivatives, belimumab, azathioprine, anifrolumab, methotrexate, rituximab, obinutuzumab, cyclosporin, tacrolimus or voclosporin.
• • Serum ALT \<5 times the normal value, serum bilirubin \<3 times the normal value, Left ventricular ejection fraction \>45% Life expectancy of more than 3 months Eastern Cooperative Oncology Group (ECOG) performance status ≤2. Psychological, sociological or geographical conditions precluding compliance A female of childbearing age must have a negative pregnancy test and is on two effective contraception methods A male must use two effective contraception methods
• Exclusion Criteria:
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• • Active cancer or receiving cancer treatment Evidence of severe lung, FVC \<45% and/or DLCO (corrected for Hb) \<30% predicted, heart (NYHA class III/IV, arrhythmia, AV block, uncontrolled hypertension), liver failure or severe neurologic disorders.
• • Pre-existing irreversible kidney damage and creatinine clearance below 30 ml/min ( to review) Severe pancytopenia HIV positivity. Active Hepatitis B, C infection. Septicemia. Pregnant/nursing female. Receiving stem cell transplant within 12 weeks of enrolment, chemotherapy or radiotherapy within 8 weeks of enrolment Active CNS involvement.