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

NCT ID: NCT07093411

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-05
• Study Completion Date: 2028-12-31

Brief Summary

A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LUCAR-E9D,LUCAR-E9K, a dual-targeted cell preparation targeting CD19/CD20, in patients with relapsed/refractory B-cell non-Hodgkin lymphoma.

Detailed Description

This is an open-label, dose-escalation/dose extension study to assess the safety, tolerability, and efficacy of LUCAR-E9D,LUCAR-E9K 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-E9D,LUCAR-E9K injection. The study will include the following sequential phases: screening, pre-treatment (lymphodepleting chemotherapy), treatment, and follow-up.

Conditions

B-cell Non-Hodgkin Lymphoma Recurrent B-cell Non-Hodgkin Lymphoma Refractory

Study Design

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

Study Groups

LUCAR-E9D or LUCAR-E9K

Each subject will be given a single-dose LUCAR-E9D or LUCAR-E9K cells infusion at each dose level.

Group Type: EXPERIMENTAL

LUCAR-E9D or LUCAR-E9K cells product

Intervention Type: BIOLOGICAL

Prior to infusion of the LUCAR-E9D or LUCAR-E9K cells product subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine

Interventions

LUCAR-E9D or LUCAR-E9K cells product

Prior to infusion of the LUCAR-E9D or LUCAR-E9K cells product 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.

6. Response to prior therapy is consistent with one of the following:

1） Patients with B-NHL who are primary refractory and are unsuitable or unwilling to receive autologous CAR-T cell therapy; 2） primary refractory is defined as the best response to first-line treatment being SD or PD; 3） Relapse within 12 months after achieving CR with first-line chemotherapy and immunotherapy; 7. Life expectancy≥ 3 months 8. Women of childbearing potential must have a negative highly sensitive serum pregnancy test (β-human chorionic gonadotropin [β-hCG]) at screening and before the first administration of cyclophosphamide and fludarabine treatment;

Exclusion Criteria

1. Diagnosed with or treated for other invasive malignancies besides B-cell non-Hodgkin lymphoma.

2. Active acute or chronic graft-versus-host disease (GVHD), except for grade 1 skin involvement; or requiring immunosuppressive treatment for GVHD within 4 weeks prior to enrollment;

3. Active CNS involvement (symptomatic or positive cerebrospinal fluid or imaging data), prior CNS infiltration but currently in remission (asymptomatic and negative cerebrospinal fluid and/or imaging data) is eligible;

4. Significant bleeding tendency, such as gastrointestinal bleeding, hemorrhagic cystitis, coagulopathy.

5. Chronic diseases treated with steroids or other immunosuppressants. The following situations are excluded: use of topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; short-term use of corticosteroids for prophylaxis;

6. Severe underlying diseases, such as: - Evidence of severe active viral, bacterial infections, or uncontrolled systemic fungal infections; - Active or unstable autoimmune diseases, or autoimmune diseases within the past 3 years with potential for relapse;

7. Breastfeeding women;

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

Sponsors

First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role: collaborator

The Affiliated Hospital of Xuzhou Medical University

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital of Xi'an Jiaotong University

OTHER

Sponsor Role: collaborator

Anhui Provincial Hospital

OTHER_GOV

Sponsor Role: collaborator

Beijing GoBroad Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

Hefei, , China

Site Status: RECRUITING

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, , China

Site Status: RECRUITING

Affiliated Hospital of Xuzhou Medical University

Xuzhou, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Kai Hu

Role: CONTACT

huk@gobroadhealthcare.com

+86 15010390336

Facility Contacts

Bing Xing Wang

Role: primary

Hong wan Zhao

Role: primary

Wei Sang

Role: primary

Other Identifiers

LB2406-0001

Identifier Type: -

Identifier Source: org_study_id