Actively Recruiting
A Clinical Study to Evaluate the Safety and Efficacy of ZZSW-01 in the Treatment of Patients With Relapsed/Refractory B-cell Malignancies
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2025-11-21
6
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and preliminary efficacy of ZZSW-01 injection in patients with relapsed or refractory B-cell blood cancers. This early-phase 1, single-center, single-arm, open-label study focuses on patients who have not responded to previous treatments. ZZSW-01 uses an extracellular vesicle that carries CD19 CAR mRNA to target these malignancies. Eligible patients will receive multiple intravenous injections of ZZSW-01, which generates CAR-T cells directly in the body. The study uses a dose-escalation design to carefully monitor safety and response. Treatment is given under close medical supervision to assess how well patients tolerate the drug and to observe any early signs of benefit. Participants will undergo regular assessments including monitoring of adverse events, dose-limiting toxicities, and immune-related side effects up to 28 days after infusion. Researchers will track disease responses and survival outcomes for up to 96 weeks post-treatment. Laboratory tests will measure CAR-T cell levels and pharmacodynamics at multiple time points during the study. This thorough follow-up aims to capture both safety and early effectiveness signals over nearly two years.
CONDITIONS
Brief Title
Safety and Efficacy of ZZSW-01 in Relapsed/Refractory B-cell Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any sex
- ECOG performance status score of 0 to 2
- Expected survival of at least 3 months
- Confirmed CD19-positive relapsed or refractory B-cell malignancies including specified lymphoma and leukemia types
- At least one measurable lesion for B-NHL or at least 5% bone marrow blasts for B-ALL
- Adequate organ function as defined by blood counts, liver, kidney, coagulation, and oxygenation levels
- Resolved non-hematologic toxicities to grade 1 or less (with some exceptions)
- Negative pregnancy test for women of childbearing potential; agreement to use effective contraception
- Ability to provide informed consent and comply with study procedures
You will not qualify if you...
- Central nervous system involvement of B-cell malignancies with related symptoms
- Isolated extramedullary relapse of B-ALL
- Severe hereditary diseases or congenital hematopoietic dysfunction
- Burkitt's lymphoma/leukemia or blast phase chronic myeloid leukemia
- History of central nervous system disorders including seizures, stroke, dementia, or autoimmune CNS diseases
- Recent chemotherapy or immune therapies within specified timeframes before infusion
- Use of systemic corticosteroids within 72 hours prior to infusion (except low-dose replacement)
- Recent targeted therapies, antibody drugs, or cytotoxic therapy before infusion
- Autologous stem cell transplantation within 6 weeks or any prior allogeneic stem cell transplantation
- Known autoimmune diseases, immunodeficiencies, or active infections including hepatitis B, C, HIV, or syphilis
- Major surgery within 4 weeks prior to screening if unsuitable
- Concurrent active malignancy (except cured prior malignancies over 2 years)
- Significant cardiac conditions or unstable angina
- Lymphoma involving heart chambers or causing clinical emergencies
- Recent deep vein thrombosis or pulmonary embolism
- Hypersensitivity to study product components
- Receipt of live vaccines within 6 weeks prior to screening
- Uncontrolled active infections
- Participation in other investigational drug trials within 3 months or intention to receive non-protocol antitumor therapy
- Any other condition judged unsuitable by the investigator
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 - Up to 96 weeks
Participants receive multiple intravenous injections of ZZSW-01, an extracellular vesicle carrying CD19 CAR mRNA, to generate CAR-T cells in vivo. The treatment aims to assess safety, tolerability, and preliminary efficacy.
Multiple visits for ZZSW-01 infusions and assessments up to 96 weeks
Duration - Up to 28 days post last infusion
Participants are monitored for safety, response, and persistence of CAR-T cells after the treatment period ends.
Multiple visits up to 28 days after last infusion
Trial Site Locations
Total: 1 location
1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China, 430022
Actively Recruiting
Research Team
H
Heng Mei, Ph.D&M.D
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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