anti-CD19/CD22 CAR-T cells / Hrain Biotech - LARVOL DELTA

A bi-specific CAR-T cell therapy targeting CD19 and CD22 in relapsed or refractory B-ALL. (PubMed, Clin Exp Med) - P1 | "Pre-clinical data from animal models reveal that CD19-CD22 CAR-T cells effectively induce cytotoxicity, thus suppressing B-ALL cell proliferation...Trial registration number ClinicalTrials.gov (No. NCT04303520)."

Journal • Acute Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • Transplantation • CD22 • GZMB • IFNG • IL6

INTRA-CSF DELIVERY OF DUAL CD19/CD22 CAR-T THERAPY FOR RELAPSED/REFRACTORY CENTRAL NERVOUS SYSTEM B-CELL MALIGNANCIES: FIRST-IN-HUMAN CLINICAL TRIAL (EHA 2025) - P1 | "Intra-CSF delivery of Dual CD19/CD22 CAR-T therapy is a promising treatment for CNS B-cell malignancies, particularly when administered directly into the CSF. Intra-CSF delivery bypasses the need for lymphodepletion, allows for lower dosing, reduces CRS incidence, minimizes neurotoxicity, and achieves rapid responses without requiring long-lasting effects.(NCT05651178)Key Points:Intra-CSF delivery of CAR-T cells is safe and feasible for CNS B-cell malignancies.Intra-CSF delivery of CAR-T cells leads to compartmentalized expansion and enhanced CNS penetration, resulting in robust early responses within the CNS.Intra-CSF delivery reduces systemic toxicity and enables rapid, targeted therapeutic effects."

Clinical • P1 data • Central Nervous System Leukemia • CNS Lymphoma • Hematological Malignancies • Hepatology • Leukemia • Liver Failure • Lymphoma • Nephrology • Oncology • Renal Disease • CD22

Human CD19-CD22 Targeted T Cells Injection for Refractory/Relapsed Central Nervous System Leukemia/Lymphoma Patients (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: Hrain Biotechnology Co., Ltd. | N=20 ➔ 10 | Trial primary completion date: Aug 2024 ➔ Nov 2024

Enrollment change • Trial primary completion date • Acute Lymphocytic Leukemia • B Cell Lymphoma • Central Nervous System Leukemia • CNS Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Oncology • CD22

Anti-CD19/CD22 Bispecific CAR-T Cell Therapy for MRD Positive ALL (clinicaltrials.gov) - P1 | N=19 | Completed | Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting ➔ Completed | Trial completion date: Aug 2022 ➔ Nov 2023 | Trial primary completion date: Aug 2022 ➔ Nov 2023

CAR T-Cell Therapy • Minimal residual disease • Trial completion • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD22

Dasatinib Plus Anti-CD19/CD22 Bispecific CAR-T Cell Therapy for Elderly Ph-positive ALL Patients (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Trial completion date: Sep 2024 ➔ Sep 2025

Trial completion date • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Human CD19-CD22 Targeted T Cells Injection for Refractory/Relapsed Central Nervous System Leukemia/Lymphoma Patients (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Hrain Biotechnology Co., Ltd.

New P1 trial • Acute Lymphocytic Leukemia • CNS Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19 • CD22 • IL15 • IL6

Anti-CD19/CD22 Bispecific CAR-T Cell Therapy for MRD Positive ALL (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | N=10 ➔ 18

CAR T-Cell Therapy • Enrollment change • Minimal residual disease • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD19 • CD22

To Evaluate the Safety and Tolerability of Human CD19-CD22 Targeted T Cells Injection for Subjects With R/R B-ALL. (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Hrain Biotechnology Co., Ltd.

New P1 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD19 • CD22 • IL15 • IL6

Hrain Bio’s CD19/CD22 CAR-T therapy tacitly nodded for clinical trials (GBI Health) - "The Center for Drug Evaluation website indicates that Hrain Biotechnology Co., Ltd’s CD19 and CD22 dual-targeting chimeric antigen receptor (CAR)-T cell therapy has obtained tacit clinical approval. The targeted indication is relapsed/refractory B-cell acute lymphoblastic leukemia (ALL)."

Non-US regulatory • Acute Lymphocytic Leukemia • Hematological Malignancies • Oncology

Anti-CD19/CD22 Bispecific CAR-T Cell Therapy for CD19-positive ALL (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine

CAR T-Cell Therapy • Clinical • New P1 trial