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

NCT06295549 | Terminated Phase 1

• 1 other identifier: LB2304-0001
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 3

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

Conditions

Relapsed and Refractory B-cell Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (4)

• Incidence, severity and type of TEAEs

  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.

  Through study completion , an average of 2 years after LUCAR-G39P infusion (Day 1)

• Pharmacokinetics in peripheral blood

  CAR positive T cells and CAR transgene levels in peripheral blood after LUCAR-G39P infusion

  ThTrough study completion , an average of 2 years after LUCAR-G39P infusion (Day 1)

• Pharmacokinetics in bone marrow

  CAR positive T cells and CAR transgene levels in bone marrow after LUCAR-G39P infusion.

  ThTrough study completion , an average of 2 years after LUCAR-G39P infusion (Day 1)

• 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

  Within 30 days after LUCAR-G39P infusion

Secondary Outcomes (6)

• Overall Response Rate (ORR)

  Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1)

• Progression-free survival (PFS)

  Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1)

• Overall Survival (OS)

  Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1)

• Time to Response (TTR)

  Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1)

• Duration of Response (DoR)

  Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1)

Study Arms (1)

Experimental: LUCAR-G39P cells product

EXPERIMENTAL

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

Biological: LUCAR-G39P cells product

Interventions

LUCAR-G39P cells product BIOLOGICAL

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

Experimental: LUCAR-G39P cells product

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:
• Primary refractory.
• Relapsed or refractory after 2 or more lines of therapy.
• 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;
• \. Life expectancy≥ 3 months 8. Clinical laboratory values meet screening visit criteria

You may not qualify if:

• Subject eligible for this study must not meet any of the following criteria:
• Prior antitumor therapy with insufficient washout period ;
• Patients who received autologous CAR-T cell therapy (except CD19-targeted) or autologous gene therapy;
• Patients who received allogeneic hematopoietic stem cell transplantation or allogeneic therapy;
• \. 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).
• \. Known life-threatening allergies, hypersensitivity, or intolerance to LUCAR-G39P CAR-T cell or its excipients, including DMSO.
• \. Pregnant or lactating women;

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Nanjing Legend Biotech Co.: collaborator

Study Sites (3)

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

Nanjin, Jiangsu, 210029, China

Location

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China

Location

Beijing Gobroad Hosptial

Beijing, 102206, China

Location

MeSH Terms

Conditions

Recurrence; Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Jianyong Li, PhD,MD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: March 6, 2024
• Study Start: April 11, 2024
• Primary Completion: June 11, 2025
• Study Completion: August 22, 2025
• Last Updated: December 1, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)