Targeting CD19/CD20 Dual-targeted Cell in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

NCT ID: NCT06295549

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-11
• Study Completion Date: 2025-08-22

Brief Summary

A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LUCAR-G39P, a dual-targeted cell preparation targeting CD19/CD20, in patients with relapsed/refractory B-cell non-Hodgkin lymphoma

Detailed Description

his is an open-label, dose-escalation/dose extension study to assess the safety, tolerability, and efficacy of LUCAR-G39P in the patient ≥ 18 years of age with relapsed or refractory B-cell non-Hodgkin lymphoma. Subjects who meet the eligibility criteria will receive a single dose of LUCAR-G39P injection. The study will include the following sequential phases: screening, pre-treatment (lymphodepleting chemotherapy), treatment, and follow-up.

Conditions

Relapsed and Refractory B-cell Non-Hodgkin Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: LUCAR-G39P cells product

Each subject will be given a single-dose LUCAR-G39P cells infusion at each dose level.

Group Type: EXPERIMENTAL

LUCAR-G39P cells product

Intervention Type: BIOLOGICAL

LUCAR-G39P cells product Prior to infusion of the LUCAR-G39P, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine

Interventions

LUCAR-G39P cells product

LUCAR-G39P cells product Prior to infusion of the LUCAR-G39P, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Subjects have fully understood the possible risks and benefits of participating in this study, are willing to follow and able to complete all trial procedures, and have signed informed consent.

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

Subject eligible for this study must not meet any of the following 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-G39P CAR-T cell or its excipients, including DMSO.

7. Pregnant or lactating women;

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Legend Biotech Co.

INDUSTRY

Sponsor Role: collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianyong Li, PhD,MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Locations

Department of Haematology, the First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital

Nanjin, Jiangsu, China

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Beijing Gobroad Hosptial

Beijing, , China

Countries

China

Other Identifiers

LB2304-0001

Identifier Type: -

Identifier Source: org_study_id