Actively Recruiting
T-cell Infusion Targeting CD19 and CD22 for Refractory or Relapsed Leukemia and Lymphoma Patients With or Without Central Nervous System Involvement
Led by Essen Biotech · Updated on 2025-08-06
75
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a new form of immunotherapy using Human CD19-CD22 Targeted T Cells for patients with relapsed or refractory B-cell blood cancers, including various leukemias and lymphomas. This phase I trial aims to evaluate the safety, tolerability, and behavior of these specially engineered T cells in the body, as well as to determine the best dose and schedule for future studies. The trial also includes patients with central nervous system lymphoma and other related blood cancers, with comprehensive assessments to confirm eligibility. Participants will first receive chemotherapy to prepare their immune system before the infusion of the CD19-CD22 CAR-T cells. The chemotherapy includes intravenous fludarabine phosphate over several days and cyclophosphamide on a specific day, followed by an intravenous infusion of the CAR-T cells. Those who respond well and tolerate the treatment without serious side effects may receive two or three additional doses. The infusion process and chemotherapy are carefully timed and monitored. During the study, participants will undergo thorough monitoring including physical exams, blood tests, and imaging scans such as CT, MRI, and PET to evaluate the treatment's effects and safety. Monitoring for side effects will continue closely, sometimes during hospitalization. The main outcome measured is the occurrence and severity of toxic effects within 28 days after infusion. The trial will also assess the ability to produce the CAR-T cells successfully. The overall study duration and follow-up are designed to ensure detailed observation of treatment responses and safety.
CONDITIONS
Brief 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 specific lymphomas without alternative curative therapies
- Chemotherapy refractory disease after two lines of therapy or disease recurrence after complete response
- Persistent or relapsed minimal residual disease (MRD) confirmed twice at least 4 weeks apart
- For Philadelphia Chromosome positive ALL, progression or relapse after two therapies including tyrosine kinase inhibitors
- Lymphoma patients progressed after initial treatments including anthracycline and anti-CD20 antibody
- CD19 expression on malignant cells at required levels
- Eligibility after prior stem cell transplants with specific conditions
- Measurable or evaluable disease present
- Recovery from prior therapies and stable toxicities
- Age between 1 and 30 years (with specific age conditions for initial dosing)
- Adequate performance status and organ function
- Negative pregnancy test for females of childbearing potential and agreement to use contraception
- Ability to give informed consent (or legal representative consent for minors)
You will not qualify if you...
- Isolated testicular relapsed or refractory ALL
- Radiologically detected CNS lymphoma or CNS 3 disease with neurological symptoms
- High blast count or rapidly progressing disease compromising treatment
- History of other malignancies unless disease-free for 3 years
- Uncontrolled infections or ongoing HIV, hepatitis B or C infections
- CNS disorders that impair neurotoxicity evaluation
- Significant cardiac disease or recent cardiac events
- Use of anticoagulation therapy
- Medical conditions interfering with treatment assessment
- History of severe allergic reactions to study agents
- Pregnant or breastfeeding women
- Unlikely to complete study visits or comply with protocol
- Primary immunodeficiency or systemic autoimmune disease with recent immunosuppression
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days
Participants receive chemotherapy to prepare their immune system for CAR-T cell therapy.
3 visits (in-person, Days -4 to -2)
Duration - Day 0 with possible additional doses
Participants receive an infusion of CD19/CD22-CAR T cells to target and destroy malignant B cells.
1 infusion visit on Day 0; additional 2 or 3 infusion visits possible depending on response and cell availability
Duration - Up to 28 days post-infusion and beyond as needed
Participants are closely monitored for side effects, clinical response, and effectiveness with various assessments including imaging and blood tests.
Multiple visits during hospitalization and follow-up assessments
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
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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