AI
Tuesday, April 30, 2024 2:37:05 PM
(OT) A post on LinkedIn by Max Qian (CEO and Co-Founder at Rui Therapeutics):
''I am so pleased today to share an exciting clinical development with our CAR-NK therapeutic platform on Autoimmune disease space. Attached six slides describe our ongoing FIH clinical trial of KN5501 (CD19 CAR-NK) that is used to treat three severe SLE (systemic lupus erythematosus) patients. We innovatively designed this dose-escalation clinical trial with 1+2+3=6 patients to complete low, medium and high dose.
SLEDAI 2K score (SLE disease activity index 2000), the most commonly used system that evaluates the severity of SLE, is used to determines changes in the disease activity of patients diagnosed with SLE: 1) mild activity (SLEDAI-2K = 6); 2) moderate activity (SLEDAI-2K 7 to 12); 3) severe activity (SLEDAI-2K>12).
· The higher the score, the more significant is the degree of disease activity.
· Scores of 6 and above are considered to be consistent with active disease requiring therapy. However, scores greater than 20 are very rare.
· Modifications of score of 6 (improvement) and of 8 (worsening) are considered clinically relevant.
Consistently, as we observed in r/rDLBCL trials, CAR-NK demonstrated a supper safety profile, i.e., no CRS nor ICANS. Very most exciting is that we observed the efficacy from the 1st three patients on low and medium dose (we even have not completed three doses with medium dose patients yet!). This might be the very 1st FIH data available globally to support CAR-NK therapy in SLE.
In earlier this year, we may hear CAR-T on SLE, but latest FDA announcement may give us (patients, hospital and manufacturers) a 2nd thought of the CAR-T approach in autoimmune disease spaces; don’t mention its other safety and economic concerns. Welcome discussions!''
''I am so pleased today to share an exciting clinical development with our CAR-NK therapeutic platform on Autoimmune disease space. Attached six slides describe our ongoing FIH clinical trial of KN5501 (CD19 CAR-NK) that is used to treat three severe SLE (systemic lupus erythematosus) patients. We innovatively designed this dose-escalation clinical trial with 1+2+3=6 patients to complete low, medium and high dose.
SLEDAI 2K score (SLE disease activity index 2000), the most commonly used system that evaluates the severity of SLE, is used to determines changes in the disease activity of patients diagnosed with SLE: 1) mild activity (SLEDAI-2K = 6); 2) moderate activity (SLEDAI-2K 7 to 12); 3) severe activity (SLEDAI-2K>12).
· The higher the score, the more significant is the degree of disease activity.
· Scores of 6 and above are considered to be consistent with active disease requiring therapy. However, scores greater than 20 are very rare.
· Modifications of score of 6 (improvement) and of 8 (worsening) are considered clinically relevant.
Consistently, as we observed in r/rDLBCL trials, CAR-NK demonstrated a supper safety profile, i.e., no CRS nor ICANS. Very most exciting is that we observed the efficacy from the 1st three patients on low and medium dose (we even have not completed three doses with medium dose patients yet!). This might be the very 1st FIH data available globally to support CAR-NK therapy in SLE.
In earlier this year, we may hear CAR-T on SLE, but latest FDA announcement may give us (patients, hospital and manufacturers) a 2nd thought of the CAR-T approach in autoimmune disease spaces; don’t mention its other safety and economic concerns. Welcome discussions!''
