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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

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