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

Study acronym: BAH241
StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Primary completion date: Feb 10, 2025 to Feb 10, 2027
    • Study completion date: Dec 10, 2025 to Dec 10, 2028
    v7
  2. Re-verified, no change to tracked fieldsv6
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 10, 2024 to Jul 10, 2024
    • Study site revised
    v5
  4. Re-verified, no change to tracked fieldsv4
  5. Start date: Feb 10, 2024 to Nov 10, 2024
    • Site details revised
    v3
  6. Study title shortened, about 18 wordsv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Essen Biotech
17 trials monitored
See all monitored trials
Leukemia
2,948 trials monitored
See 180 trials at risk
Non-Hodgkin Lymphoma
2,013 trials monitored
See 115 trials at risk
Acute Lymphoblastic Leukemia (ALL)
931 trials monitored
See 58 trials at risk
and 3 more diseases
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.
Trial Details
NCT Number NCT06213636
Lead Sponsor Essen Biotech
Conditions
(from sponsor)		 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
Related terms Lymphoma, B-Cell, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov