GC007F / AstraZeneca - LARVOL DELTA

Novel CD19 chimeric antigen receptor T cells manufactured next-day for acute lymphoblastic leukemia. (PubMed, Blood Cancer J) - "GC007F demonstrated superior expansion capacity and a less exhausted phenotype as compared to (C-CAR-T) cells. Moreover, this first-in-human clinical study showed that the novel, next-day manufacturing FasTCAR-T cells was feasible with a manageable toxicity profile in patients with R/R B-ALL."

CAR T-Cell Therapy • Journal • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Inflammation • Leukemia • Oncology • CD19

A Study of GC007F CAR-T Cell Immunotherapy for Relapsed or Refractory B- ALL (clinicaltrials.gov) - P1 | N=29 | Completed | Sponsor: Hebei Yanda Ludaopei Hospital | Recruiting ➔ Completed | N=20 ➔ 29

CAR T-Cell Therapy • Enrollment change • Trial completion • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD19

Anti-CD19/CD22 Dual CAR-T Therapy for Refractory and Relapsed B-Cell Acute Lymphoblastic Leukemia (ASH 2019) - P1; "All pts received conditioning regimen of fludarabine and cyclophosphamide intravenously for 3 consecutive days with doses of 30 mg/m2/day and 250 mg/m2/day, respectively before a single infusion of CAR-T cells...A low toxicity with dose-dependent high CR rate including pts who previously treated with CD19 CAR-T cells were observed. Longer observation time and more patients are needed to evaluate a beneficial advantage of the CD19/CD22 dual CAR-T over CD19 CAR-T product."

IO biomarker • Acute Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • Pediatrics • IFNG • IL10 • IL2RA • IL6

Gracell Biotechnologies Receives Medical Products Manufacturing Certificate for CAR-T Cell Therapy Products (PRNewswire) - "Gracell Biotechnologies Inc...has been granted the Medical Products Manufacturing Certificate (MPMC) from the Jiangsu Medical Products Administration (JSMPA, Jiangsu is a province/state in China) for its CAR-T cell therapy products...has fully met the compliance requirements for Good Manufacturing Practice (GMP) in relation to the production of CAR-T cell therapy for cancer treatment."

Non-US regulatory • Oncology

A Bcma and CD19 Bispecific CAR-T for Relapsed and Refractory Multiple Myeloma (ASH 2019) - "One patient did not receive lymphodepletion, and all other 4 patients received i.v. fludarabine and cyclophosphamide for 3 days...Additionally BCMA-CD19 CAR-T cells were shown to be more cytotoxic than single CAR-T both in vitro and in vivo...Bispecific CAR-T manufacturing on the FasT CAR-T platform is successful and has been shown to be more potent. A clinical study to evaluate safety and efficacy of FasT BCMA-CD19 CAR-T is ongoing."

IO Biomarker • CD8

Role of Donor-Derived CD19.CAR-T Cells in Treating Patients That Relapsed after Allogeneic Hematopoietic Stem Cell Transplantation (ASH 2019) - "No second transplantation was needed for relapsed patients after allo-HSCT with the treatment of donor-derived CAR-T cells that with good chimerism and continual proliferation of CAR-T cells. However, further clinical trials should be performed to investigate this protocol with larger cases."

CAR T-Cell Therapy • Clinical

A NOVEL FAST CD19 CAR-T CELLS: RAPID AND EFFICIENT TREATMENT FOR REFRACTORY B-ALL(BP-CML) (EHA 2019) - "Three days after FC preconditioning (fludarabine 50mg d1-3, cyclophosphamide 300mg d1-3), a low dose of FasT CAR-T cells (5×104/kg) was infused. The clinical trial (ChiCTR-OOC-16008448) is launched to explore new indications, proper dosages and side-effects. At present, we have successfully treated three r/r B-ALL patients with FasT CD19 CAR-T therapy."

CAR T-Cell Therapy • IO Biomarker