CTD401 / Nanjing Bioheng Biotech - LARVOL DELTA

CD7-targeted universal CAR T-cell therapy in relapsed or refractory (R/R) acute myeloid leukemia (AML): Clinical results from CTD401/402 studies (ASH 2025) - P1, P2 | "(NCT04538599, NCT05902845,NCT05895994, NCT05454241) In these investigator-initiated trials, eligible CD7+ R/R AML patients received lymphodepletionwith fludarabine (25-30mg/m2) and cyclophosphamide (400-850mg/m2) for 3-5 days, with/withoutetoposide (100mg/m2) for 3 or 5 days...One developed Grade 2ICANS after CTD402 redosing due to absent expansion following initial infusion... CTD401/402 were well tolerated up to 1×10⁹ CAR⁺ T cells with no DLTs. Among patients withhigh CD7 expression, best overall response rate reached 62.5%, supporting CD7 as a viable target in amolecularly defined AML subset. Subsequent HSCT/HCB may be crucial for sustaining remission afterCAR T-cell therapy, and in selected AML patients, CD7-directed CAR T cells may allow foregoing/reductionof myeloablation, enabling potentially curative transplantation with reduced toxicity as we havepreviously published (NEJM 2024)."

CAR T-Cell Therapy • Clinical • IO biomarker • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Leukopenia • Neutropenia • Thrombocytopenia • CD123 • CD33 • CD7 • IL3RA

A Novel Universal CD7-Targeted CAR-T Cell Therapy for Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia and T-Cell Lymphoblastic Lymphoma (ASH 2022) - P=N/A | "Intravenous fludarabine (25-30 mg/m2/d), cyclophosphamide (300mg/m2/d) and etoposide (100 mg/m2/d) were given to all patients on Day -6 to Day -3 prior to CD7 UCAR-T cell infusion. Conclusions Our phase I trial showed that the allogeneic "off-the-shelf" RD13-01 product was safe and dose-dependently effective in treating patients with heavily pretreated T-ALL/LBL, including those with EMD and prior allo-HSCT, those who already failed autologous CD7 CAR-T therapy, and who could not manufacture autologous CAR-T from the patient's own PB due to high blasts in PB and those with rapid disease progression. Long-term observation and more patients are needed to further evaluate the safety and efficacy of CD7 UCAR-T cells."

CAR T-Cell Therapy • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Infectious Disease • Inflammation • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • Transplantation • ABL1 • BCR • CD7 • CDH1 • TP53

Bioheng Biotech Announces Publication of Impressive Results with CD7-targeted allogeneic CAR-T cell therapy for Relapsed or Refractory T Cell Malignancies (PRNewswire) - P1 | N=12 | NCT04538599 | "Nanjing Bioheng Biotech Co., Ltd...announced that a phase I clinical study results of RD13-01, an anti-CD7 universal CAR-T therapy product, have been published in the reputable academic journal, Cell Research....RD13-01 demonstrated a manageable safety and tolerability profile, no DLT, GvHD or ICANS was observed, and no patients experienced ≥ grade 3 CRS. Of the 11 patients included in efficacy analysis, 9 (82%) achieved an objective response. Of the 8 patients with leukemia, 6 (75%) achieved MRD-CR/CRi."

P1 data • Hematological Malignancies • Oncology

Genetically modified CD7-targeting allogeneic CAR-T cell therapy with enhanced efficacy for relapsed/refractory CD7-positive hematological malignancies: a phase I clinical study. (PubMed, Cell Res) - P1 | "In summary, we present the first report of a Phase I clinical trial using healthy donor-derived CD7-targeting allogeneic CAR-T cells to treat CD7 hematological malignancies. Our results demonstrated the encouraging safety and efficacy profiles of the RD13-01 allogeneic CAR-T cells for CD7 tumors."

CAR T-Cell Therapy • Journal • P1 data • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Cytomegalovirus Infection • Diffuse Large B Cell Lymphoma • Epstein-Barr Virus Infections • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Inflammation • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • CD7