CTA101 / Nanjing Bioheng Biotech - LARVOL DELTA

CAR‑T Cell Therapy With CRISPR/CAS9 Engineering for Relapsed/Refractory B‑Cell Acute Lymphoblastic Leukemia, With Universal Dual Target CD19/CD22 (SOHO 2023) - "The utilization of CRISPR/ Cas9 technology facilitated highly efficient and precise gene editing, resulting in the production of universal CAR-T cells. No genotoxicity or chromosomal translocation associated with gene editing was observed. Six patients received infusions of CTA101 at doses of 1 (3 patients) and 3 (3 patients) × 106 CAR+ T cells per kilogram of body weight."

CAR T-Cell Therapy • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD22 • CD52

China CDE Approved First Universal CAR-T IND ! (PRNewswire) - "On March 17, 2022, China National Drug Administration Drug Review Center (CDE) approved first Universal Chemeric Antigen Receptor T (UCAR-T) cell drug (Acceptance No. : CXSL2101509). CTA101 is independently developed by Nanjing Bioheng Biotech Co., Ltd ( hereinafter referred as 'Bioheng'), targeting CD19 and CD22, for the indication of adult recurrent or refractory B-cell acute lymphoblastic leukemia ( r / r B-ALL )."

New trial • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

[VIRTUAL] The Safety and Efficacy of a CRISPR/Cas9-Engineered Universal CAR-T Cell Product (CTA101) in Patients with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (ASH 2020) - P1 | "Prior to CTA101 infusion, pts received pre-conditioning chemotherapy regimen consisting of cyclophosphamide, fludarabine and alemtuzumab...All pts experienced CRS (3 G1, 2 G2, 1 G3), and the G3 CRS recovered within 7 days with one dose of tocilizumab and glucocorticoids...Early data of cellular PK and efficacy illustrate that CRISPR gene editing does not curtail the expansion and anti-leukemia capacity of CAR-T. Updated data, including long term gene editing-related AEs, will be presented after further follow-up."

CAR T-Cell Therapy • Clinical • IO biomarker • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Oncology • Pneumonia • Respiratory Diseases • Septic Shock • CD19 • CD52

CRISPR/Cas9-engineered universal CD19/CD22 dual-targeted CAR-T cell therapy for relapsed/refractory B-cell acute lymphoblastic leukemia. (PubMed, Clin Cancer Res) - "CRISPR/Cas9-engineered universal CD19/CD22 CAR-T cells exhibited a manageable safety profile and prominent anti-leukemia activity. Universal dual-targeted CAR-T cell therapy may offer an alternative therapy for patients with r/r ALL."

CAR T-Cell Therapy • Journal • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukaemia • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Oncology • CD19 • CD22 • CD52

"China's Nanjing Bioheng Biotech develolping CTA101, a Crispr-edited CD19/CD22 Car; 5/6 CR in r/r ALL, via He Huang #ASH20 $CRSP" (@JacobPlieth)

CD19

"interesting that CTA-101 abstract" (@BertrandBio)

Bioheng Announced Oral Presentation of Its Preliminary Results of CRISPR-Engineered Allogeneic CAR-T for r/r B-ALL Treatment at 2020 ASH Meeting (PRNewswire) - "Bioheng Biotech Co...today announced that their preliminary data including the pre-clinical development, manufacturing, and investigator initiated trial (IIT) results for CTA101...will be presented at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition to be held virtually on December 5-8, 2020. The study was designed to evaluate the feasibility of CTA101 in patients with relapsed/refractory B-cell acute Lymphoblastic Leukemia (r/r B-ALL)."

Clinical data • Preclinical • Acute Lymphocytic Leukemia • Hematological Malignancies • Oncology

A Study of CTA101 UCAR-T Cell Injection in Patients With Relapsed or Refractory CD19+ B-line Hematological Malignancy (clinicaltrials.gov) - P1; N=72; Recruiting; Sponsor: He Huang

Clinical • New P1 trial