Actively Recruiting
Human CD19 Targeted T Cells Injection(CD19 CAR-T) Therapy for Relapsed and Refractory B-cell Non-Hodgkin's Lymphoma
Led by Hrain Biotechnology Co., Ltd. · Updated on 2022-07-05
100
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
H
Hrain Biotechnology Co., Ltd.
Lead Sponsor
S
Shanghai Zhongshan Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
A Phase Ⅱ Clinical Study Evaluating the Efficacy and Safety of Human CD19 Targeted T Cells Injection (CD19 CAR-T) Therapy for R/R B-NHL. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19 CAR+ T cells.
CONDITIONS
Official Title
Human CD19 Targeted T Cells Injection(CD19 CAR-T) Therapy for Relapsed and Refractory B-cell Non-Hodgkin's Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older with relapsed or refractory B-cell non-Hodgkin's lymphoma
- Expected survival time greater than 12 weeks
- ECOG performance status score between 0 and 2
- Diagnosis confirmed by cytology or histopathology according to 2016 WHO criteria, including DLBCL, PMBCL, TFL, or HGBCL
- Relapsed/refractory disease after standard first-line and at least two second-line treatments, or relapse after stem cell transplantation
- Suitable venous access for leukapheresis with adequate blood counts: hemoglobin ≥80 g/L, neutrophils ≥1.0×10⁹/L, platelets ≥75×10⁹/L
- At least one measurable tumor lesion according to Lugano 2014 criteria
- Liver, kidney, and cardiopulmonary function within specified limits (creatinine, cardiac ejection fraction >50%, blood oxygen saturation >92%, bilirubin, ALT, AST levels)
- Ability to understand and sign informed consent
You will not qualify if you...
- Malignant tumors other than specified lymphoma types within 5 years before screening, except certain treated cancers
- Positive for Hepatitis B surface antigen or core antibody with elevated HBV DNA, positive for Hepatitis C antibody and RNA, HIV positive, or syphilis positive
- Uncontrolled systemic diseases such as active infections (except localized), angina, cerebrovascular accident, myocardial infarction, severe heart failure, arrhythmia, liver, kidney, or metabolic diseases
- Any other uncontrolled active disease preventing participation
- Investigator judgment of safety risk or interference with study
- Pregnancy, lactation, or planned pregnancy within one year post-treatment
- Active or uncontrolled infection requiring systemic therapy within 14 days before enrollment
- Recent systemic steroid treatment or systemic anti-tumor therapy (except local therapy)
- Previous CAR-T or gene-modified cell therapy
- Symptoms or treatment for central nervous system or brain metastases within 3 months before enrollment
- Inability or unwillingness to comply with study procedures or sign informed consent
- Considered unsuitable by investigator for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here