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Trial Title:
A Study of LUCAR-20SP in Subjects With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
NCT ID:
NCT06313957
Condition:
Relapsed B-cell Non-Hodgkin Lymphoma
Refractory B-cell Non-Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Conditions: Keywords:
Relapsed B-cell non-Hodgkin lymphoma
Refractory B-cell non-Hodgkin lymphoma
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
LUCAR-20SP cells
Description:
Prior to infusion of the LUCAR-20SP, subjects will receive a conditioning premedication
regimen consisting of cyclophosphamide and fludarabine.
Arm group label:
Each subject will receive LUCAR-20SP cells
Summary:
This is a prospective, single-arm, open-label, exploratory clinical study of LUCAR-20SP
in adult subjects with relapsed/refractory B-cell non-Hodgkin lymphoma.
Detailed description:
This is a prospective, single-arm, open-label exploratory clinical study to evaluate the
safety, tolerability, pharmacokinetics and anti-tumor efficacy profiles of LUCAR-20SP, an
allogenic CAR-T cell therapy in subjects with relapsed/refractory B-cell non-Hodgkin
lymphoma. Patients who meet the eligibility criteria will receive LUCAR-20SP infusion.
The study will include the following sequential stages: screening, pre-treatment
(lymphodepleting chemotherapy), treatment and follow-up.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Subjects voluntarily participate in clinical research;
- Age ≥18 years old;
- Eastern Cooperative Oncology Group (ECOG) score 0-1;
- Histologically confirmed large B-cell lymphoma, follicular lymphoma, mantle cell
lymphoma, histologically indolent lymphoma to diffuse large B-cell lymphoma; CD20
positive;
- At least one measurable tumor lesion according to the Lugano 2014.
- Expected survival ≥3 months;
- Clinical laboratory values in the screening period meet criteria.
- Effective contraception.
Exclusion Criteria:
- Prior antitumor therapy with insufficient washout period.
- Previous treatment with allogeneic cell and gene therapy (such as CAR-T); Except
subjects with evidence that previous allogeneic cell and gene therapy products (such
as CAR-positive T cells and CAR transgenes) in the subject have been below the lower
limit of detection;
- Previously received allogeneic hematopoietic stem cell transplantation;
- Previously received gene therapy;
- Donor specific antibody (DSA) positive subjects will be excluded;
- Severe underlying diseases;
- Hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C virus ribonucleic
acid (HCV RNA) or human immunodeficiency virus antibody (HIV-Ab) positive;
- Presence of other serious pre-existing medical conditions that may limit patient
participation in the study. Any condition that, in the investigator's judgment, will
make the subject unsuitable for participation in this study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University Cancer Hospital & Institute
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Yuqin Song
Phone:
13683398726
Email:
songyq22622@163.com
Contact backup:
Last name:
Yan Xie
Phone:
13671376201
Email:
xieyan9@263.net
Investigator:
Last name:
Yuqin Song
Email:
Principal Investigator
Start date:
March 14, 2024
Completion date:
September 2028
Lead sponsor:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Collaborator:
Agency:
Nanjing Legend Biotech Co.
Agency class:
Industry
Source:
Peking University Cancer Hospital & Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06313957