Clinical Research Directory

Isatuximab in Adult Patients With Cytologic or Molecular Relapsed/Refractory CD38 Positive T-cell Acute Lymphoblastic Leukemia

The planned trial offers treatment cohorts for patients with full cytologic relapse (R/R ALL - Cohort 1), as well as for patients with molecular failure/relapse (MRD+ ALL - Cohort 2). Basically, the study aims to develop data for optimization of first-line therapy of T-ALL, either by modification of standard induction with Isatuximab or by establishing a post-induction therapy for eradication of MRD and thereby evaluates in parallel two different strategies.

CD123-Directed T-Cell Therapy for Acute Myelogenous Leukemia (CATCHAML)

The CD123-CAR T-cell therapy is a new treatment that is being investigated for treatment of AML/myelodysplastic syndrome (MDS), T- or B- acute lymphoblastic leukemia (ALL) or blastic plasmacytoid dendritic cell neoplasia (BPDCN). The purpose of this study is to find the maximum (highest) dose of CD123-CAR T cells that is safe to give to these patients. This would include studying the side effects of the chemotherapy, as well as the CD123-CAR T-cell product on the recipient's body, disease and overall survival. Primary Objective: * To determine the safety of one intravenous infusion of escalating doses of autologous, CD123-CAR T cells in patients (≤21 years) with recurrent/refractory CD123+ disease (AML/MDS, B-ALL, T-ALL or BPDCN) after lymphodepleting chemotherapy. * To determine the safety of an intravenous infusion of escalating doses of donor derived, CD123-CAR T cells in patients (≤21 years) with recurrent/refractory CD123+ disease (AML/MDS, B-ALL, T-ALL, BPDCN or MPAL) after lymphodepleting chemotherapy. Secondary Objectives \- To evaluate the antileukemia activity of CD123-CAR T cells. Exploratory Objectives * To assess the immunophenotype, clonal structure and endogenous repertoire of CD123-CAR T cells and unmodified T cells * To characterize the cytokine profile in the peripheral blood and CSF after treatment with CD123-CAR T cells * To characterize tumor cells post CD123-CAR T-cell therapy * To compare in vivo properties of donor-derived versus autologous CD123- CAR T cells

Clinical Trial of CD38 Monoclonal Antibody Combined With Chemotherapy for T-Cell Acute Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia (ALL) is a group of common hematological malignancies characterized by high aggressiveness and heterogeneity. Over the past 50 years, outcomes for pediatric ALL have significantly improved, with approximately 90% of children achieving long-term survival. In adults, ALL accounts for 20%-30% of acute leukemias, and nearly two-thirds of adult ALL cases are Philadelphia chromosome-negative (Ph-negative). Based on immunophenotype, Ph-negative ALL can be further classified into B-cell ALL (B-ALL) and T-cell ALL (T-ALL). T-ALL constitutes 15%-25% of Ph-negative ALL cases and is associated with poorer clinical prognosis compared to B-ALL, including lower induction remission rates and a higher risk of relapse, even among patients who achieve complete remission (CR). Over the past two decades, only nelarabine has been FDA-approved for relapsed/refractory T-ALL, but this drug is not available in China. Given the current therapeutic limitations, novel strategies to improve T-ALL outcomes are urgently needed. CD38, a cell surface antigen highly and stably expressed on T-ALL cells with minimal influence from prior chemotherapy, has emerged as a promising therapeutic target. Preliminary clinical data for daratumumab, a CD38-targeted monoclonal antibody, demonstrate improved objective response rates (ORR) in pediatric and young adult patients compared to historical controls, along with favorable safety and tolerability. CM313 injection (referred to as "CM313"), developed by Keymed Biosciences (Chengdu) Co., Ltd., is a humanized monoclonal antibody with proprietary intellectual property. Preclinical studies confirm that CM313 specifically binds to CD38 on the surface of hematologic tumor cells, including myeloma, lymphoma, and ALL. It exerts antitumor effects via multiple mechanisms: antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), antibody-dependent cellular phagocytosis (ADCP), and Fc crosslinking-induced apoptosis. Additionally, CM313 inhibits CD38 ectoenzyme activity. In vitro and in vivo pharmacodynamic studies indicate comparable antitumor efficacy between CM313 and daratumumab. This study aims to evaluate the safety and efficacy of CM313 combined with pediatric-inspired chemotherapy regimens for induction therapy in adults with newly diagnosed T-ALL, providing a foundation for extending CD38 monoclonal antibody applications to T-ALL consolidation therapy.

The Safety and Efficacy of VGO-Cs01p in Patients With CD7-positive Relapsed/Refractory Acute T-lymphoblastic Leukemia

To learn if the VGO-Cs01p can help to control CD7-positive relapsed/refractory acute T-lymphoblastic leukemia (R/R T-ALL) in children.

CD7 CAR-T in Adults With Relapsed or Refractory T-LBL/ALL Clinical Study

To evaluate the tolerability and safety of SENL101 in patients with relapsed or refractory T-LBL/ALL.