Clinical Trial

Fourth-gen CAR T Cells Targeting CD19/CD22 for Highly Resistant B-cell Lymphoma/Leukemia (PMBCL/CNS-BCL).

Study acronym: BAH241
Recruiting Phase 1/2
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Summary
This is an open-label, single-arm, phase I clinical trial with dose escalation designed to investigate the safety, tolerability, and pharmacokinetic properties of Human CD19-CD22 Targeted T Cells Infusion. The primary objectives are to preliminarily assess the impact of Human CD19-CD22 Targeted T Cells Infusion in patients with relapsed/refractory B-cell acute lymphoblastic leukemia and to explore the appropriate dose and reinfusion schedule for phase II. Eligible participants, including those with Central Nervous System Lymphoma, B Cell Lymphoma (BCL), Acute Lymphocytic Leukemia (ALL), Acute Lymphoblastic Leukemia (ALL), B Acute Lymphoblastic Leukemia (B-ALL), Refractory Non-Hodgkin Lymphoma, Refractory Chronic Lymphocytic Leukemia (CLL), Refractory B Acute Lymphoblastic Leukemia (B-ALL), Diffuse Large B Cell Lymphoma, Lymphoid Leukemia, and MRD-positive cases, can participate. Eligibility will be determined through a comprehensive assessment, including disease evaluations, a physical examination, Electrocardiograph, Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET), and blood tests. Prior to the infusion of CD19-CD22 CAR+ T cells, participants will undergo chemotherapy. After the infusion, participants will be closely monitored for potential side effects and the effectiveness of CD19-CD22 CAR+ T cells. Certain study procedures may be conducted during hospitalization.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2024-01-10; most recent amendment 2025-08-05.
Status change: Not Yet Recruiting → Recruiting 2024-08-06
Trial Details
NCT Number NCT06213636
Lead Sponsor Essen Biotech
Conditions Acute Lymphoblastic Leukemia, Adult B-Cell, Acute Lymphoblastic Leukemia, in Relapse, Non-Hodgkin Lymphoma, B-cell, Diffuse Large B Cell Lymphoma, Central Nervous System Lymphoma, Lymphoma, Follicular, MCL
Enrollment 75 participants
Start Date 2024-07-10
Primary Completion 2027-02-10 (estimated)
Study Completion 2028-12-10 (estimated)
Updated on ClinicalTrials.gov 2025-08-06