Actively Recruiting
Early Phase 1 Trial of Human CD19-CD22 Targeted T Cells for Refractory or Relapsed Central Nervous System B Cell Malignancies
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
Researchers are evaluating the safety, tolerability, and pharmacokinetics/pharmacodynamics of Human CD19-CD22 Targeted T Cells administered both intravenously and intrathecally in patients with refractory or relapsed B cell malignancies involving the central nervous system. This early phase 1 open-label trial also aims to preliminarily observe the effectiveness of these genetically modified T cells in treating this condition. Participants will receive a preconditioning chemotherapy before infusion of the autologous anti-CD19/CD22 CAR transduced T cells. The treatment involves dose escalation to assess safety and tolerability. Following the infusion, patients will be closely monitored, with study procedures potentially conducted during hospitalization. Throughout the study, participants will undergo various assessments including disease evaluations, physical exams, electrocardiograms, imaging such as CT, MRI, or PET scans, cerebrospinal fluid exams, and blood tests. Researchers will track adverse events, pharmacokinetics/pharmacodynamics, and treatment efficacy, with a primary focus on dose-limiting toxicities and serious adverse events within 28 days post-infusion.
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
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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.
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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