Targeting CD19/CD20 Dual-targeted Cell in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
NCT ID: NCT06395870
Last Updated: 2024-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
33 participants
INTERVENTIONAL
2024-05-09
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LUCAR-G39D cells product
Each subject will be given a single-dose LUCAR-G39D cells infusion at each dose level.
LUCAR-G39D cells product
Prior to infusion of the LUCAR-G39D, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.
Interventions
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LUCAR-G39D cells product
Prior to infusion of the LUCAR-G39D, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.
Eligibility Criteria
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Inclusion Criteria
2. Aged 18-75 years (inclusive).
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Histologically confirmed B-cell non-Hodgkin Lymphoma that expresses at least one of CD19/CD20.
5. At least one evaluable tumor lesion according to Lugano 2014 criteria.
Response to prior therapy is consistent with one of the following:
1. Primary refractory.
2. Relapsed or refractory after 2 or more lines of therapy.
3. For LBCL, 3B FL. t-iNHL:
* Relapse within 12 months after first-line chemoimmunotherapy to achieve CR;
* Progression or relapse within 12 months after autologous hematopoietic stem cell transplantation;
7\. Life expectancy≥ 3 months 8. Clinical laboratory values meet screening visit criteria
Exclusion Criteria
1\. Prior antitumor therapy with insufficient washout period ; 2. Patients who received autologous CAR-T cell therapy (except CD19-targeted) or autologous gene therapy; 3. Patients who received allogeneic hematopoietic stem cell transplantation or allogeneic therapy; 5. Patients who are positive for any index of hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), or human immunodeficiency virus antibody (HIV- Ab).
6\. Known life-threatening allergies, hypersensitivity, or intolerance to LUCAR-G39D CAR-T cell or its excipients, including DMSO.
7\. Pregnant or lactating women;
18 Years
75 Years
ALL
No
Sponsors
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Nanjing Legend Biotech Co.
INDUSTRY
Tianjin Medical University Cancer Institute and Hospital
OTHER
Responsible Party
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Huilai Zhang
Director of lymphoma department
Locations
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Oncology Department, The First Affiliated Hospital of USTC west district
Hefei, Anhui, China
Tianjin Cancer Hospital
Tianjin, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LB2303-0001
Identifier Type: -
Identifier Source: org_study_id
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