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

NCT07093411 | Recruiting Early Phase 1

• 1 other identifier: LB2406-0001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Incidence, severity and type of TEAEs (Treatment-emergent Adverse Events)

  An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

  2 years after LUCAR-E9D,LUCAR-E9K infusion

• Pharmacokinetics in peripheral blood

  CAR positive T cells and CAR transgene levels in peripheral blood after LUCAR-E9D,LUCAR-E9K infusion.

  2 years after LUCAR-E9D,LUCAR-E9K infusion

• Pharmacokinetics in bone marrow

  CAR positive T cells and CAR transgene levels in bone marrow after LUCAR-E9D,LUCAR-E9K infusion.

  2 years after LUCAR-E9D,LUCAR-E9K infusion

• The recommended Phase II dose (RP2D) for this cell therapy

  RP2D established through ATD+BOIN design and the DLTs occurring following CAR T-cell infusion

  30 days after LUCAR-E9D,LUCAR-E9K infusion

Secondary Outcomes (7)

• Overall Response Rate (ORR)

  Through study completion, 2 years after LUCAR-E9D,LUCAR-E9K infusion

• Progression-free survival (PFS)

  Through study completion, 2 years after LUCAR-E9D,LUCAR-E9K infusion

• Overall Survival (OS)

  Through study completion, 2 years after LUCAR-E9D,LUCAR-E9K infusion

• Time to Response (TTR)

  Through study completion, minimum 2 years after LUCAR-E9D,LUCAR-E9K infusion (Day 1)

• Time to Response (TTR)

  Through study completion, 2 years after LUCAR-E9D,LUCAR-E9K infusion

Study Arms (1)

LUCAR-E9D or LUCAR-E9K

EXPERIMENTAL

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

Biological: LUCAR-E9D or LUCAR-E9K cells product

Interventions

LUCAR-E9D or LUCAR-E9K cells product 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

LUCAR-E9D or LUCAR-E9K

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Aged 18-75 years (inclusive).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Histologically confirmed B-cell non-Hodgkin Lymphoma that expresses at least one of CD19/CD20.
• At least one evaluable tumor lesion according to Lugano 2014 criteria.
• Response to prior therapy is consistent with one of the following:
• ） 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;

You may not qualify if:

• Diagnosed with or treated for other invasive malignancies besides B-cell non-Hodgkin lymphoma.
• 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;
• 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;
• Significant bleeding tendency, such as gastrointestinal bleeding, hemorrhagic cystitis, coagulopathy.
• 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;
• 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;
• Breastfeeding women;

Sponsors & Collaborators

• Beijing GoBroad Hospital: lead
• First Affiliated Hospital of Wenzhou Medical University: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• The Affiliated Hospital of Xuzhou Medical University: collaborator
• Second Affiliated Hospital of Xi'an Jiaotong University: collaborator
• Anhui Provincial Hospital: collaborator

Study Sites (3)

The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

Hefei, China

RECRUITING

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

RECRUITING

Affiliated Hospital of Xuzhou Medical University

Xuzhou, China

RECRUITING

Central Study Contacts

Kai Hu

CONTACT

+86 15010390336; huk@gobroadhealthcare.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: July 30, 2025
• Study Start: August 5, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 20, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)