Actively Recruiting
Targeting CD19/CD20 Dual-targeted Cell in Patients With Relapsed/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
216 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
A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LUCAR-G39D, a dual-targeted cell preparation targeting CD19/CD20, in patients with relapsed/refractory B-cell non-Hodgkin lymphoma.
CONDITIONS
Official 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...
- Fully understand risks and benefits and able to complete all trial procedures with signed consent
- Aged 18-75 years (inclusive)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically confirmed B-cell non-Hodgkin lymphoma expressing CD19 or CD20
- At least one evaluable tumor lesion per Lugano 2014 criteria
- Primary refractory or relapsed/refractory after 2 or more therapy lines
- For LBCL, 3B FL, or t-iNHL: relapse within 12 months after first-line chemoimmunotherapy to achieve complete remission or progression/relapse within 12 months after autologous hematopoietic stem cell transplant
- Life expectancy of at least 3 months
- Clinical lab values meet screening criteria
You will not qualify if you...
- Prior antitumor therapy with insufficient washout period
- Previous autologous CAR-T cell therapy (except CD19-targeted) or autologous gene therapy
- Previous 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 allergy, hypersensitivity, or intolerance to LUCAR-G39D CAR-T cell or its excipients, including DMSO
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
K
Kaiyang Ding
CONTACT
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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