Actively Recruiting
A Phase I Study Evaluating Safety, Tolerability, and Efficacy of LUCAR-20SP, An Allogenic CAR-T Cell Therapy Targeting CD20 in Adults With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Led by Peking University Cancer Hospital & Institute · Updated on 2025-03-25
42
Participants Needed
3
Research Sites
104 weeks
Total Duration
On this page
Sponsors
P
Peking University Cancer Hospital & Institute
Lead Sponsor
N
Nanjing Legend Biotech Co.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are exploring the use of LUCAR-20SP, an allogenic CAR-T cell therapy, in adults with relapsed or refractory B-cell non-Hodgkin lymphoma. This study is a prospective, single-arm, open-label clinical trial aiming to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor effects of LUCAR-20SP in this patient population. The study focuses on patients with specific types of B-cell lymphoma that have not responded to previous treatments or have relapsed. Participants will receive an infusion of LUCAR-20SP cells following a conditioning premedication regimen that includes cyclophosphamide and fludarabine. The trial includes several stages: screening, pre-treatment with lymphodepleting chemotherapy, treatment with the LUCAR-20SP infusion, and follow-up. The treatment is designed to assess the appropriate dose and monitor the body's response to this cellular therapy. During the study, participants will undergo various assessments including safety monitoring, evaluation of adverse events, and pharmacokinetic measurements in blood and bone marrow over at least two years after infusion. Researchers will also measure treatment responses such as objective response rate, time to response, duration of remission, progression-free survival, and overall survival. The study involves regular follow-up visits to track these outcomes and assess the development of antibodies against LUCAR-20SP, ensuring thorough monitoring of participants throughout the trial period.
CONDITIONS
Brief Title
A Study of LUCAR-20SP in Subjects With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects voluntarily participate in clinical research
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically confirmed large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, or indolent lymphoma to diffuse large B-cell lymphoma; CD20 positive
- At least one measurable tumor lesion according to Lugano 2014 criteria
- Expected survival of 3 months or more
- Clinical laboratory values meet criteria during screening
- Use of effective contraception
You will not qualify if you...
- Prior antitumor therapy without sufficient washout period
- Previous treatment with allogeneic cell and gene therapy such as CAR-T unless previous products are undetectable
- Previous allogeneic hematopoietic stem cell transplantation
- Previous gene therapy
- Donor specific antibody (DSA) positive
- Severe underlying diseases
- Positive for hepatitis B virus DNA, hepatitis C virus RNA, or HIV antibodies
- Other serious medical conditions limiting participation as judged by investigator
- Any condition making the subject unsuitable for the study as judged by investigator
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 visit (in-person) for screening and enrollment
Duration - Several days
Participants receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine prior to receiving the LUCAR-20SP infusion.
1 to 2 visits for chemotherapy administration
Duration - 1 day
Participants receive a single infusion of LUCAR-20SP, an allogenic CAR-T cell therapy targeting CD20.
1 infusion visit (in-person)
Duration - Minimum 2 years
Participants are monitored for safety, tolerability, pharmacokinetics, and efficacy for at least 2 years after the LUCAR-20SP infusion.
Regular visits for monitoring during the follow-up period
Trial Site Locations
Total: 3 locations
1
Beijing GoBroad Boren Hospital
Beijing, Beijing Municipality, China, 100070
Actively Recruiting
2
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
3
Henan Cancer Hospital
Zhengzhou, China
Actively Recruiting
Research Team
Y
Yuqin Song
Y
Yan Xie
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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