Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT06395870

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

Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2024-11-06

33

Participants Needed

2

Research Sites

216 weeks

Total Duration

On this page

Sponsors

T

Tianjin Medical University Cancer Institute and Hospital

Lead Sponsor

N

Nanjing Legend Biotech Co.

Collaborating Sponsor

AI-Summary

What this Trial Is About

A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LUCAR-G39D, a dual-targeted cell preparation targeting CD19/CD20, in patients with relapsed/refractory B-cell non-Hodgkin lymphoma.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Fully understand risks and benefits and able to complete all trial procedures with signed consent
  • Aged 18-75 years (inclusive)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Histologically confirmed B-cell non-Hodgkin lymphoma expressing CD19 or CD20
  • At least one evaluable tumor lesion per Lugano 2014 criteria
  • Primary refractory or relapsed/refractory after 2 or more therapy lines
  • For LBCL, 3B FL, or t-iNHL: relapse within 12 months after first-line chemoimmunotherapy to achieve complete remission or progression/relapse within 12 months after autologous hematopoietic stem cell transplant
  • Life expectancy of at least 3 months
  • Clinical lab values meet screening criteria
Not Eligible

You will not qualify if you...

  • Prior antitumor therapy with insufficient washout period
  • Previous autologous CAR-T cell therapy (except CD19-targeted) or autologous gene therapy
  • Previous allogeneic hematopoietic stem cell transplantation or allogeneic therapy
  • Positive for hepatitis B surface antigen, hepatitis B DNA, hepatitis C antibody, hepatitis C RNA, or HIV antibody
  • Known life-threatening allergy, hypersensitivity, or intolerance to LUCAR-G39D CAR-T cell or its excipients, including DMSO
  • Pregnant or lactating women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Oncology Department, The First Affiliated Hospital of USTC west district

Hefei, Anhui, China, 230000

Actively Recruiting

2

Tianjin Cancer Hospital

Tianjin, China, 300060

Actively Recruiting

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Research Team

H

Huilai Zhang

CONTACT

K

Kaiyang Ding

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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