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

November 4, 2024 updated by: Huilai Zhang, Tianjin Medical University Cancer Institute and Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

33

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Tianjin, China, 300060
        • Recruiting
        • Tianjin cancer hospital
        • Contact:
    • Anhui
      • Hefei, Anhui, China, 230000
        • Recruiting
        • Oncology Department, The First Affiliated Hospital of USTC west district
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

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

  1. Primary refractory.
  2. Relapsed or refractory after 2 or more lines of therapy.

  3. 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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LUCAR-G39D cells product
Each subject will be given a single-dose LUCAR-G39D cells infusion at each dose level.
Biological: LUCAR-G39D cells product
Prior to infusion of the LUCAR-G39D, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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-G39D infusion (Day 1)
Pharmacokinetics in peripheral blood
Time Frame: Through study completion , an average of 2 years after LUCAR-G39D infusion (Day 1).
CAR positive T cells and CAR transgene levels in peripheral blood after LUCAR-G39D infusion.
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)
CAR positive T cells and CAR transgene levels in bone marrow after LUCAR-G39D infusion.
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
RP2D established through ATD+BOIN design and the DLTs occurring following CAR T-cell infusion.
Within 30 days after LUCAR-G39D infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
Time Frame: Through study completion, an average of 2 years after LUCAR-G39D infusion (Day 1)
Objective Response Rate (ORR) is defined as the proportion of subjects who achieve CR or PR after treatment via LUCAR-G39D cell infusion
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)
Progression Free Survival (PFS) is defined as the time from the date of first infusion of the LUCAR-G39D to the first documented disease progression (according to Lugano 2014) or death (due to any cause), whichever occurs first
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)
Overall Survival (OS) is defined as the time from the date of first infusion of LUCAR-G39D to death of the subject
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)
Time to Response (TTR) is defined as the time from the date of first infusion of LUCAR-G39D to the date of the first response evaluation of the subject who has met all criteria for CR or PR.
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)
Duration of Remission (DoR) is defined as the time from the first documentation of remission (CR or PR) to the first documented relapse evidence of the responders.
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)
The incidence of Anti- LUCAR-G39D antibody in patients who received LUCAR-G39D cells infusion
Through study completion, an average of 2 years after LUCAR-G39D infusion (Day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Collaborators

Nanjing Legend Biotech Co.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

April 29, 2024

First Submitted That Met QC Criteria

April 29, 2024

First Posted (Actual)

May 2, 2024

Study Record Updates

Last Update Posted (Actual)

November 6, 2024

Last Update Submitted That Met QC Criteria

November 4, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LB2303-0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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