RecruitingPhase 1Phase 2NCT06213636

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

T-cell Infusion Targeting CD19 and CD22 for Refractory/Relapsed Leukemia/Lymphoma Patients With or Without Central Nervous System Involvement

Sponsor

Essen Biotech

Enrollment

75 participants

Start Date

Jul 10, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Lymphoblastic Leukemia, Adult B-Cell Acute Lymphoblastic Leukemia, in Relapse

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.

Eligibility

Min Age: 2 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a next-generation CAR T-cell therapy — a treatment where a patient's own immune cells are genetically reprogrammed to attack cancer — targeting two proteins (CD19 and CD22) found on B-cell blood cancers. It is intended for patients with highly treatment-resistant B-cell leukemia or lymphoma, including cases that have spread to the brain or spinal fluid. **You may be eligible if...** - You have B-cell acute lymphoblastic leukemia (B-ALL) or an aggressive B-cell lymphoma that has not responded to or has relapsed after at least two lines of therapy - You are not eligible for, declined, or relapsed after a stem cell transplant - Your cancer has shown continued activity or relapse on testing - You have Philadelphia chromosome-positive leukemia that progressed after two or more treatments including targeted drugs - You have isolated relapse in the brain or spinal fluid after previously achieving remission **You may NOT be eligible if...** - Your cancer has responded to available treatments and other options remain - You have severe organ failure or active uncontrolled infection - You have recently received certain other immune therapies that would interfere with treatment - You are pregnant or breastfeeding - You have significant heart problems or poor performance status Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCD19/CD22-CAR T cells

The intervention in this clinical trial involves a novel approach using CD19/CD22-Chimeric Antigen Receptor T (CAR T) cells combined with chemotherapy. The goal is to assess safety and efficacy in patients with specific hematologic malignancies. Treatment Regimen: Patients in the trial will undergo the following regimen: Fludarabine Phosphate (Days -4 to -2): IV administration of fludarabine phosphate over 30 minutes on days -4 to -2. It's part of the preparatory regimen to enhance the body's response to CAR T-cell therapy. Cyclophosphamide (Day -2): IV cyclophosphamide over 60 minutes on day -2. CD19/CD22-Chimeric Antigen Receptor T Cells (Day 0): IV administration of investigational therapy, CD19/CD22-CAR T cells, over 10-20 minutes on day 0. Additional Doses: Eligible patients responding well to the initial CD19/CD22-CAR T cell infusion without unacceptable side effects and sufficient CAR T cell availability may receive 2 or 3 additional doses.

Locations(1)

District One Hospital

Beijing, Beijing Municipality, China

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NCT06213636

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