Actively Recruiting
Fourth-gen CAR T Cells Targeting CD19/CD22 for Highly Resistant B-cell Lymphoma/Leukemia (PMBCL/CNS-BCL).
Led by Essen Biotech · Updated on 2025-08-06
75
Participants Needed
1
Research Sites
230 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Fourth-gen CAR T Cells Targeting CD19/CD22 for Highly Resistant B-cell Lymphoma/Leukemia (PMBCL/CNS-BCL).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of relapsed or refractory acute lymphoblastic leukemia (ALL) or lymphoma with no available curative therapies or refusal of alternative therapies
- Chemotherapy refractory disease defined as progression or stable disease after two lines of therapy
- Recurrence of disease after complete response
- Persistent or relapsed minimal residual disease (MRD) confirmed twice at least 4 weeks apart
- Philadelphia Chromosome positive ALL progressed after two lines of therapy including tyrosine kinase inhibitors
- Recurrence of isolated CNS relapse after complete remission with MRD confirmation if applicable
- Lymphoma patients must have progressed after initial treatments including anthracycline and anti-CD20 antibody, or progressed post-autologous transplant or be ineligible for transplant
- CD19 expression on malignant cells required, demonstrated by immunohistochemistry or flow cytometry
- Subjects post-autologous or allogeneic stem cell transplant with no active graft-versus-host disease and meeting other criteria
- Prior anti-CD19 or anti-CD22 CAR therapy allowed if <5% circulating CAR T cells
- Evaluable or measurable disease present
- Minimum 2 weeks or 5 half-lives since prior systemic therapy before leukapheresis with exceptions
- Stable toxicities from prior therapies recovered to ≤ Grade 1
- Age between 1 and 30 years at enrollment
- Performance status ≥ 50% (Karnofsky for >10 years or Lansky for ≤10 years)
- Adequate organ and marrow function as defined by blood counts and organ tests
- Specific CNS status without neurologic symptoms for ALL or lymphoma
- Negative pregnancy test for females of childbearing potential
- Willingness to use contraception during and 4 months after preparative regimen
- Ability to give informed consent or assent as appropriate
You will not qualify if you...
- Recurrent or refractory ALL limited to isolated testicular disease
- Radiologically detected CNS lymphoma or CNS 3 disease with blasts in cerebrospinal fluid and/or clinical signs
- Hyperleukocytosis (≥50,000 blasts/µL) or rapidly progressive disease
- History of other malignancies unless disease-free for at least 3 years
- Uncontrolled infections requiring intravenous antimicrobials
- Ongoing infection with HIV, hepatitis B, or hepatitis C unless viral load undetectable
- CNS disorders impairing neurotoxicity assessment
- Recent significant cardiac disease or cardiac lymphoma involvement
- Receiving anticoagulation therapy
- Medical conditions interfering with safety or efficacy assessment
- History of severe hypersensitivity to study agents
- Pregnant or breastfeeding women
- Unlikely to complete protocol visits or comply with study requirements
- Primary immunodeficiency or systemic autoimmune disease causing end organ injury or requiring immunosuppression within last 2 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
District One Hospital
Beijing, Beijing Municipality, China, 086-373
Actively Recruiting
Research Team
R
Rhoda M Smith, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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