CALL-1 for Adult ALL

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CALL-1 (CAR-T against Acute Lymphoblastic Leukemia)

About C-CAR011

CBMG’s proprietary anti-CD19 chimeric antigen receptor T-cell (CAR-T) construct represents advancement over CBMG’s prior CBM-C19.1 construct, which completed a human proof-of-concept trial demonstrating an optimistic response rate with controllable toxicities. C-CAR011 is entirely engineered and manufactured in CBMG’s own GMP manufacturing facility in China.2

About Acute Lymphoblastic Leukemia (ALL)
Acute Lymphoblastic Leukemia (ALL), also called acute lymphocytic leukemia, starts from the early type of white blood cells called lymphocytes in the bone marrow. The leukemia cells then invade the blood fairly quickly and may spread to other parts of the body, including the lymph nodes, liver, spleen, central nervous system (brain and spinal cord), and testicles (in males). The World Health Organization defines “acute” when greater than 20% of the cells in the bone marrow are blasts, which can progress quickly, and if untreated, would likely be fatal within months. According to the U.S. National Cancer Institute, 6,600 patients are diagnosed with ALL in the U.S. annually. Additionally, it is estimated that 27,000 patients in China will be diagnosed with ALL annually. While pediatric patients make up approximately 60% of the total and achieve an 85% effective cure rate, only 40% of Adult ALL patients achieve long-term disease-free survival.

Name of StudyA Phase I Study Evaluating Safety and Efficacy of C-CAR011 Treatment in Adult Subjects With r/r CD19+B-ALL
PhaseClinical Trial Phase I
ClinicalTrials.gov IdentifierNCT03018093 - view study online here
Study TypeInterventional
Study DesignIntervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Principal InvestigatorDr. Li Yu
Hospital(s)PLA General Hospital (“PLAGH”)