Actively Recruiting
A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of the CD19/CD20 Dual-Target in Vivo CAR-T Lentiviral Product in the Treatment of Relapsed/Refractory B-cell Malignancies
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2026-05-14
30
Participants Needed
6
Research Sites
104 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital with Nanjing Medical University
Lead Sponsor
N
Nanjing Legend Biotech Co.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of a new CD19/CD20 Dual-Target in vivo CAR-T Lentiviral product in adults aged 18 years or older with relapsed or refractory B-cell malignancies. This Phase I clinical trial focuses on patients with certain blood cancers who have not responded to previous treatments or whose disease has returned. The study aims to understand how well this novel cell therapy works and its safety profile. Participants will receive a single infusion of the CD19/CD20 Dual-Target in vivo CAR-T Lentiviral product. Before the infusion, some patients may receive bridging therapy if needed to control their disease. The study includes several phases: screening to determine eligibility, possible bridging therapy, treatment with the CAR-T product, and a follow-up period lasting up to about two years to monitor responses and side effects. During the study, participants will be closely monitored through clinical evaluations and laboratory tests to assess tumor response and the therapy's effects on the body. Key measures include tracking adverse events, drug levels in blood and bone marrow, and immune response. Researchers will also evaluate overall survival, progression-free survival, time to response, and duration of response. The total study participation spans approximately two years after treatment, with safety and efficacy assessments throughout this period.
CONDITIONS
Brief Title
The CD19/CD20 Dual-Target in Vivo CAR-T Lentiviral Product in the Treatment of Relapsed/Refractory B-cell Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects voluntarily agree to participate and have signed informed consent prior to any study-specific procedures
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- At least one evaluable tumor lesion
- Diagnosed with relapsed or refractory non-Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CLL) with treatment indications
- Life expectancy of at least 3 months
- Clinical laboratory values meet screening criteria
- Adequate organ function
You will not qualify if you...
- Prior antitumor therapy without sufficient washout period
- Previous treatment with lentiviral vector-based gene therapies
- Positive for hepatitis B surface antigen, hepatitis B DNA, hepatitis C antibody, hepatitis C RNA, or HIV antibody
- History of life-threatening allergic reactions or severe hypersensitivity to study drug components or related substances
- Lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Variable, depending on individual need
Participants receive bridging therapy if it is needed prior to the CAR-T Lentiviral product infusion.
Visit schedule depends on bridging therapy requirements
Duration - Single infusion day
Participants receive a single dose infusion of the CD19/CD20 Dual-Target in vivo CAR-T Lentiviral product.
1 infusion visit (in-person)
Duration - Up to 2 years
Participants are monitored for safety, efficacy, and pharmacokinetics after treatment, with assessments continuing for up to 2 years.
Regular follow-up visits over 2 years
Trial Site Locations
Total: 6 locations
1
The First Affiliated Hospital of USTC west district
Hefei, Anhui, China, 230000
Actively Recruiting
2
Beijing Gobroad Boren Hospita
Beijing, Beijing Municipality, China, 102206
Actively Recruiting
3
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050000
Actively Recruiting
4
The First Affiliated Hospital of ZHENGZHOU University
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
5
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
6
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Actively Recruiting
Research Team
F
FAN Lei
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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