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Recruiting NCT06395870

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

Phase I Interventional B-Cell Non-Hodgkin Lymphoma-Recurrent B-Cell Non-Hodgkin Lymphoma-Refractory

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LUCAR-G39D cells product.
Who it may be relevant to
Registry conditions: B-Cell Non-Hodgkin Lymphoma-Recurrent, B-Cell Non-Hodgkin Lymphoma-Refractory. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

This is an open-label, dose-escalation/dose extension study to assess the safety, tolerability, and efficacy of LUCAR-G39D 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-G39D injection. The study will include the following sequential phases: screening, pre-treatment (lymphodepleting chemotherapy), treatment, and follow-up.

Interventions

  • Biological LUCAR-G39D cells product
    Prior to infusion of the LUCAR-G39D, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.

Primary outcome measures

  • Incidence, severity and type of TEAEs (Treatment-emergent Adverse Events) [Time frame: Through study completion , an average of 2 years after LUCAR-G39D infusion (Day 1)]
  • Pharmacokinetics in peripheral blood [Time frame: Through study completion , an average of 2 years after LUCAR-G39D infusion (Day 1).]
  • Pharmacokinetics in bone marrow [Time frame: Through study completion , an average of 2 years after LUCAR-G39D infusion (Day 1)]
  • The recommended Phase II dose (RP2D) for this cell therapy [Time frame: Within 30 days after LUCAR-G39D infusion]
Secondary outcome measures (6)
  • Overall Response Rate (ORR) [Time frame: Through study completion, an average of 2 years after LUCAR-G39D infusion (Day 1)]
  • Progression-free survival (PFS) [Time frame: Through study completion, an average of 2 years after LUCAR-G39D infusion (Day 1)]
  • Overall Survival (OS) [Time frame: Through study completion, an average of 2 years after LUCAR-G39D infusion (Day 1)]
  • Time to Response (TTR) [Time frame: Through study completion, an average of 2 years after LUCAR-G39D infusion (Day 1)]
  • Duration of Response (DoR) [Time frame: Through study completion, an average of 2 years after LUCAR-G39D infusion (Day 1)]
  • Immunogenicity assessment of LUCAR-G39D cells [Time frame: Through study completion, an average of 2 years after LUCAR-G39D infusion (Day 1)]

Eligibility criteria

Inclusion criteria

  • 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;

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-G39D CAR-T cell or its excipients, including DMSO.

7\. Pregnant or lactating women;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • Oncology Department, The First Affiliated Hospital of USTC west district — Hefei
  • Tianjin Cancer Hospital — Tianjin

Identifiers

NCT: NCT06395870 · LB2303-0001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗