Actively Recruiting
A Phase I, Open-label Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LUCAR-G39D, a Dual-targeted Cell Therapy Targeting CD19/CD20 in Adults With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2024-11-06
33
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
Sponsors
T
Tianjin Medical University Cancer Institute and Hospital
Lead Sponsor
N
Nanjing Legend Biotech Co.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating LUCAR-G39D, a dual-targeted cell therapy aimed at CD19 and CD20, in adults aged 18 to 75 with relapsed or refractory B-cell non-Hodgkin lymphoma. This phase I, open-label study focuses on assessing the safety, tolerability, and effectiveness of this treatment in patients who have not responded to previous therapies or have relapsed after multiple treatment lines. Participants will receive a single infusion of LUCAR-G39D cells following a preparatory chemotherapy regimen with cyclophosphamide and fludarabine to reduce immune cells before treatment. The study includes several phases: screening, pre-treatment with chemotherapy, treatment with the cell infusion, and follow-up to monitor ongoing effects. During the study, participants will undergo various assessments including monitoring for treatment-related side effects, blood and bone marrow tests to track how the therapy behaves in the body, and evaluations of tumor response and survival outcomes over an average of two years. The study team will also assess immune responses to the therapy and determine the best dose for future studies.
CONDITIONS
Brief Title
Targeting CD19/CD20 Dual-targeted Cell in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 to 75 years (inclusive)
- Able to understand study risks and benefits and willing to complete all trial procedures with signed informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically confirmed B-cell non-Hodgkin lymphoma expressing CD19 and/or CD20
- At least one measurable tumor lesion per Lugano 2014 criteria
- Disease status consistent with primary refractory, or relapsed/refractory after two or more prior therapies
- For certain lymphoma types, relapse within 12 months of first-line chemoimmunotherapy or progression within 12 months after autologous stem cell transplant
- Life expectancy of at least 3 months
- Clinical laboratory values meeting screening criteria
You will not qualify if you...
- Prior antitumor therapy without sufficient washout period
- Previous autologous CAR-T cell therapy (except CD19-targeted) or autologous gene therapy
- Prior allogeneic hematopoietic stem cell transplantation or allogeneic therapy
- Positive for hepatitis B surface antigen, hepatitis B DNA, hepatitis C antibody, hepatitis C RNA, or HIV antibody
- Known life-threatening allergies or intolerance to LUCAR-G39D or its excipients including DMSO
- Pregnant or breastfeeding 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.
screening and enrollment visit
Duration - A few days prior to treatment
Participants receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine as conditioning before the cell therapy infusion.
1 visit (in-person)
Duration - Single day
Participants receive a single dose infusion of LUCAR-G39D cells to treat relapsed or refractory B-cell non-Hodgkin lymphoma.
1 infusion visit (in-person)
Duration - Up to 2 years after treatment
Participants are monitored for safety, tolerability, efficacy, and pharmacokinetics of LUCAR-G39D for up to approximately 2 years after infusion.
Multiple follow-up visits over 2 years
Trial Site Locations
Total: 2 locations
1
Oncology Department, The First Affiliated Hospital of USTC west district
Hefei, Anhui, China, 230000
Actively Recruiting
2
Tianjin Cancer Hospital
Tianjin, China, 300060
Actively Recruiting
Research Team
H
Huilai Zhang
K
Kaiyang Ding
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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