Actively Recruiting
KSV01 Injection as the Therapy for Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia
Led by Zhejiang University · Updated on 2025-11-24
30
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang University
Lead Sponsor
T
TCRx Therapeutics Co.Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single center, single arm, open-label, dose escalation, phase 1 study to evaluate the safety, tolerability and preliminary efficacy of KSV01 injection for patients with relapsed/refractory B-Cell acute lymphoblastic leukemia (r/r B-ALL).
CONDITIONS
Official Title
KSV01 Injection as the Therapy for Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation with written informed consent
- Age 18 to 80 years, any gender
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy greater than 3 months
- Diagnosis of relapsed or refractory B-cell Acute Lymphoblastic Leukemia (B-ALL) as defined by specific relapse or refractory criteria
- Documented CD19-positive leukemia cells in bone marrow or peripheral blood within 1 month prior to screening
- Bone marrow blasts at least 5%
- For Philadelphia chromosome-positive ALL, refractory or intolerant to at least two Tyrosine Kinase Inhibitors (TKIs), except for T315I mutation patients
- Absolute Lymphocyte Count (ALC) at least 100/µL
- Adequate organ function including liver enzymes, kidney function, oxygen saturation, and cardiac function
- Negative pregnancy test for women of childbearing potential and agreement to use effective contraception for at least 1 year post-infusion
- For prior blinatumomab therapy, documented CD19 tumor expression on blasts with at least 90% CD19-positive blasts if quantified
You will not qualify if you...
- Diagnosis of Burkitt's leukemia/lymphoma or chronic myeloid leukemia in accelerated or blast phase
- Another primary malignancy not in remission for at least 2 years, with some exceptions
- Uncontrolled active infection within 4 weeks prior to enrollment
- Active hepatitis B or C infection
- HIV infection
- Positive for syphilis
- Severe active autoimmune disease or immunodeficiency except well-controlled diabetes and thyroid disorders
- History of severe allergy or hypersensitivity to biological agents
- Participation in another interventional trial within 4 weeks prior to enrollment
- Significant central nervous system disorders or CNS involvement beyond defined limits
- Genetic syndromes associated with bone marrow failure
- Significant cardiovascular conditions within past 6 months
- Active psychiatric illness
- History of drug abuse or addiction
- Recent use of specific medications or therapies including salvage chemotherapy, prior anti-CD19 therapies other than blinatumomab, certain immunosuppressive treatments, checkpoint inhibitors, radiotherapy, corticosteroids at therapeutic doses, gene therapy, or adoptive cell therapy
- Acute or chronic graft-versus-host disease requiring systemic therapy within 4 weeks prior to enrollment
- Administration of live vaccine within 4 weeks prior to enrollment
- Pregnancy or lactation
- Any condition that may affect ability to complete study visits or comply with requirements according to investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
First Affiliated Hospital of Zhejiang University
Hangzhou, China
Actively Recruiting
Research Team
H
He Huang, MD
CONTACT
Y
Yongxian Hu, MD
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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