Actively Recruiting
Human CD19-CD22 Targeted T Cells Injection for Refractory/Relapsed Central Nervous System Leukemia/Lymphoma Patients
Led by Hrain Biotechnology Co., Ltd. · Updated on 2025-01-07
10
Participants Needed
1
Research Sites
159 weeks
Total Duration
On this page
Sponsors
H
Hrain Biotechnology Co., Ltd.
Lead Sponsor
S
Second Affiliated Hospital of Nanchang University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a open-label, dose-escalation trial to explore the safety, tolerability and pharmacokinetic/pharmacodynamics characteristics of Human CD19-CD22 Targeted T Cells by intravenous and intrathecal administration, and to preliminarily observe the efficacy of the trial drug in patients with central nervous system involvement of refractory/relapsed B cell malignancies.
CONDITIONS
Official Title
Human CD19-CD22 Targeted T Cells Injection for Refractory/Relapsed Central Nervous System Leukemia/Lymphoma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with B cell malignancies positive for CD19 or CD22, including relapsed acute lymphoblastic leukemia or refractory/relapsed B cell lymphoma with central nervous system involvement
- Age between 18 and 70 years, including both males and females
- Expected survival greater than 12 weeks
- ECOG performance status score of 0 to 2
- Confirmed diagnosis of central nervous system B cell malignancy by cerebrospinal fluid and/or imaging (MRI, PET/CT)
- Venous access suitable for cell collection and ability to undergo leukapheresis as judged by investigators
- Normal liver, kidney, and cardiopulmonary function meeting specified laboratory and clinical criteria
- Ability to understand and sign the informed consent form
You will not qualify if you...
- Presence of malignant tumors other than B cell malignancies within 5 years prior to screening, except certain treated cancers
- Positive for Hepatitis B surface antigen or core antibody with detectable virus DNA, positive Hepatitis C antibody and RNA, positive HIV antibody, or positive syphilis test
- Unstable systemic diseases such as unstable angina, recent stroke, recent myocardial infarction, severe heart failure, severe arrhythmia, or significant liver, kidney, or metabolic disease
- Active or uncontrolled infection requiring systemic treatment within 14 days prior to enrollment
- Pregnant or breastfeeding women, or participants planning pregnancy within 1 year after cell infusion, including partners
- Previous CAR-T or other gene therapy treatments
- Current or recent systemic steroid treatment requiring long-term use, except inhaled or topical steroids
- Any other conditions deemed unsuitable for enrollment by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
Research Team
X
Xuedong Sun, 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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