anti-CD7 CAR-T cell therapy / Shanghai Yake Biotech - LARVOL DELTA

Donor-Derived CD7 Chimeric Antigen Receptor T Cells for T-Cell Prolymphocytic Leukemia: Two Case Reports (ASH 2024) - "After three courses of bendamustine, he failed to achieve complete remission (CR)...After multiple courses of treatment (Including cyclophosphamide, doxorubicin, vincristine, prednisone, anti-CD52 monoclonal antibody, fludarabine, mitoxantrone liposome, etoposide, chidamide, PI3K inhibitors and other drugs), she failed to achieve CR...After tocilizumab, low-dose corticosteroids and vasopressor, the temperature returned to normal and the above symptoms improved...She died from hemoptysis due to pulmonary fungal infection while waiting for transplantation.CONCLUSION Donor-derived CD7 CAR T cells are effective and safe for refractory and relapsed T-PLL. Bridging to allo-HSCT is a potential cure for the disease."

CAR T-Cell Therapy • Case report • Clinical • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Hypotension • Infectious Disease • Leukemia • Oncology • Prolymphocytic Leukemia • Respiratory Diseases • CD7 • CD8 • CD99 • IL6 • PTPRC

CD7 CAR-T Bridging to alloHSCT for Severe Aplastic Anemia (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Zhejiang University

New P1 trial • Anemia • Aplastic Anemia • Bone Marrow Transplantation • Hematological Disorders • Transplantation

Clinical Study on the Safety and Efficacy of CD7 CAR-T Cell in Patients With Relapsed/Refractory Acute Leukemia (clinicaltrials.gov) - P1/2 | N=200 | Recruiting | Sponsor: The General Hospital of Western Theater Command

CAR T-Cell Therapy • IO biomarker • New P1/2 trial • Hematological Malignancies • Leukemia • Oncology

Clinical Trial for the Safety and Efficacy of Anti-CD7 CAR-T Cell Therapy for Patients With Relapsed or Refractory CD7 Positive Hematological Malignancy (clinicaltrials.gov) - P1 | N=81 | Recruiting | Sponsor: Zhejiang University | Phase classification: P1/2 ➔ P1 | Trial completion date: Dec 2023 ➔ Dec 2025 | Trial primary completion date: Dec 2022 ➔ Dec 2023

CAR T-Cell Therapy • Phase classification • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Oncology • CD7

Allogenic and autologous anti-CD7 CAR-T cell therapies in relapsed or refractory T-cell malignancies. (PubMed, Blood Cancer J) - "Patients treated with allogeneic CAR-T cells had higher remission rate, less recurrence and more durable CAR-T survival than those receiving autologous products. Allogeneic CAR-T cells appeared to be a better option for patients with T-cell malignancies."

CAR T-Cell Therapy • Journal • Acute Lymphocytic Leukemia • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • Transplantation

CD7 CAR-T Bridging to alloHSCT for R/R CD7+Malignant Hematologic Diseases (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Zhejiang University

IO biomarker • New P2 trial • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Oncology • Transplantation • CD7

HIGH SAFETY AND EFFICACY OF ANTI-CD7 CAR-T CELLS IN TREATING RELAPSED OR REFRACTORY CD7+ ACUTE MYELOID LEUKEMIA: FIRST-IN-HUMAN PHASE I STUDY (EBMT 2023) - P1/2 | "Patients with R/R AML underwent leukapheresis and a lymphodepletion chemotherapy with cyclophosphamide and fludarabine or etoposide before CAR-T cell infusion. In this first-in-human study of anti-CD7 CAR-T cells for R/R AML, anti-CD7 CAR-T cells exhibited promising efficacy with manageable toxicity profile. A phase II trial of anti-CD7 CAR-T cells in larger patient cohorts is needed."

CAR T-Cell Therapy • Clinical • IO biomarker • P1 data • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • Transplantation • CD123 • CD33 • FLT3

Allogeneic and Autologous Anti-CD7 CAR-T Cell Therapies in Relapsed or Refractory T Cell Malignancies (ASH 2022) - P1 | "Patients underwent lymphodepletion with fludarabine and cyclophosphamide followed by CAR-T infusion at a dose of 1x106 or 2x106/kg on D0...Due to the higher relapse rate in patients receiving autologous CAR-T cells, we recommend consolidation therapy should be considered. For patients with allogeneic CAR-T cells, long-term monitoring and timely intervention for hemogram and infection may significantly improve patients' outcomes. Larger sample size and longer follow-up are needed to confirm this conclusion."

CAR T-Cell Therapy • Acute Graft versus Host Disease • Acute Lymphocytic Leukemia • Cerebral Hemorrhage • Chronic Graft versus Host Disease • Cutaneous T-cell Lymphoma • Dermatology • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Inflammation • Leukemia • Lymphoma • Mycosis Fungoides • Oncology • Pneumonia • Respiratory Diseases • T Acute Lymphoblastic Leukemia • Thrombocytopenia • Transplantation

CD7 CHIMERIC ANTIGEN RECEPTOR T CELLS FOR ADULT PATIENTS WITH REFRACTORY AND RELAPSED T CELL MALIGNANCIES (EHA 2022) - P1 | "Auto- or allo-CAR-T have similar efficacy and safety in the process, thus optimal solutions can be selected depending on their situations. CD7 CAR-T presents a potential therapeutic option for adults with R/R T cell malignancies, but the long-term prognosis remains to be observed and improved."

CAR T-Cell Therapy • Clinical • IO biomarker • Cutaneous T-cell Lymphoma • Dermatology • Graft versus Host Disease • Hematological Disorders • Immune Modulation • Immunology • Infectious Disease • Inflammation • Leukopenia • Mycosis Fungoides • Oncology • Pediatrics • Pneumonia • Respiratory Diseases • T Acute Lymphoblastic Leukemia • CD19 • CD7 • CD8 • CTLA4

Donor-Derived CD7 Chimeric Antigen Receptor T Cells for T-Cell Acute Lymphoblastic Leukemia: First-in-Human, Phase I Trial. (PubMed, J Clin Oncol) - P2 | "Among 20 patients with r/r T-ALL enrolled in this trial, donor-derived CD7 CAR T cells exhibited efficient expansion and achieved a high complete remission rate with manageable safety profile. A multicenter, phase II trial of donor-derived CD7 CAR T cells is in progress (NCT04689659)."

CAR T-Cell Therapy • Journal • P1 data • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Inflammation • Leukemia • Oncology • Pneumonia • Respiratory Diseases • T Acute Lymphoblastic Leukemia • Transplantation • CD7

Clinical Study of Targeting CD7 CAR-T Cells in the Treatment of Autoimmune Diseases (clinicaltrials.gov) - P1 | N=75 | Recruiting | Sponsor: Zhejiang University

CAR T-Cell Therapy • New P1 trial • Crohn's disease • Dermatomyositis • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammatory Bowel Disease • Myositis • Rheumatoid Arthritis • Ulcerative Colitis

Clinical Trial for the Safety and Efficacy of Anti-CD7 CAR-T Cell Therapy for Patients With Relapsed or Refractory CD7 Positive Hematological Malignancy (clinicaltrials.gov) - P1/2; N=108; Recruiting; Sponsor: Zhejiang University

CAR T-Cell Therapy • Clinical • New P1/2 trial • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Oncology