Actively Recruiting
Safety and Efficacy of ZZSW-01 in 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
150 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-center, single-arm, open-label, dose-escalation, early-phase 1 study to evaluate the safety, tolerability and preliminary efficacy of ZZSW-01 injection in patients with relapsed/refractory B-cell malignancies.
CONDITIONS
Official 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 malignancy, including specific B-NHL subtypes or precursor B-ALL
- For B-NHL: at least one measurable lesion (e.g., lymph node >15 mm or extranodal lesion >10 mm)
- For precursor B-ALL: baseline bone marrow blasts of 5% or more
- Adequate blood cell counts and organ function as defined, including specific blood parameters and liver, kidney, coagulation, and oxygen levels
- Non-hematologic toxicities from prior treatments resolved to grade 1 or less (except alopecia and certain neurotoxicities)
- Negative pregnancy test for women of childbearing potential and agreement to use effective contraception during and for 6 months after the study
- Ability and willingness to provide informed consent and comply with study procedures
You will not qualify if you...
- CNS involvement of B-cell malignancies with symptoms confirmed by lumbar puncture or MRI
- Isolated extramedullary relapse of B-ALL
- Severe hereditary diseases or congenital blood disorders
- Burkitt's lymphoma/leukemia or blast phase chronic myeloid leukemia
- History of central nervous system disorders such as seizures, stroke, dementia, Parkinson's, or autoimmune CNS diseases
- Chemotherapy within 2 weeks prior to infusion (except intrathecal chemotherapy stopped at least 1 week prior)
- Recent immune checkpoint inhibitor or systemic antitumor therapies within specified time frames before infusion
- Use of systemic corticosteroids within 72 hours prior to infusion (except low-dose replacements)
- Recent targeted therapies, antibody drugs, or cytotoxic therapy before infusion
- Autologous stem cell transplant within 6 weeks or any prior allogeneic hematopoietic stem cell transplant
- Known systemic vasculitis, lupus, active autoimmune diseases, or immunodeficiency
- Active infections including hepatitis B or C, HIV, or syphilis
- Major surgery within 4 weeks before screening if unsuitable
- Concurrent active malignancy unless cured for 2 years or more
- Significant cardiac conditions including low ejection fraction, heart failure, severe arrhythmia, uncontrolled hypertension, recent heart attack or surgeries
- Lymphoma involving heart chambers
- Clinical emergencies from lymphoma masses causing obstruction or compression
- Recent history of deep vein thrombosis or pulmonary embolism
- Allergies to multiple drugs or investigational product components
- Live vaccines within 6 weeks before screening
- Uncontrolled active infections at screening
- Participation in other investigational drug trials within 3 months prior or intent to participate during this study
- Any other conditions judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
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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