A Study of LUCAR-20SP in Subjects with Relapsed/refractory B-cell Non-Hodgkin Lymphoma

March 20, 2025 updated by: Peking University Cancer Hospital & Institute

A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LUCAR-20SP, an Allogenic Chimeric Antigen Receptor(CAR)-T Cell Therapy Targeting CD20 in Subjects with Relapsed/refractory B-cell Non-Hodgkin Lymphoma

This is a prospective, single-arm, open-label, exploratory clinical study of LUCAR-20SP in adult subjects with relapsed/refractory B-cell non-Hodgkin lymphoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, single-arm, open-label exploratory clinical study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor efficacy profiles of LUCAR-20SP, an allogenic CAR-T cell therapy in subjects with relapsed/refractory B-cell non-Hodgkin lymphoma. Patients who meet the eligibility criteria will receive LUCAR-20SP infusion. The study will include the following sequential stages: screening, pre-treatment (lymphodepleting chemotherapy), treatment and follow-up.

Study Type

Interventional

Enrollment (Estimated)

42

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
      • Zhengzhou, China
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Peking University Cancer Hospital & Institute
        • Contact:
        • Contact:
        • Contact:
          • Yuqin Song
      • Beijing, Beijing, China, 100070

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:

  • Subjects voluntarily participate in clinical research;
  • Age ≥18 years old;
  • Eastern Cooperative Oncology Group (ECOG) score 0-1;
  • Histologically confirmed large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, histologically indolent lymphoma to diffuse large B-cell lymphoma; CD20 positive;
  • At least one measurable tumor lesion according to the Lugano 2014.
  • Expected survival ≥3 months;
  • Clinical laboratory values in the screening period meet criteria.
  • Effective contraception.

Exclusion Criteria:

  • Prior antitumor therapy with insufficient washout period.
  • Previous treatment with allogeneic cell and gene therapy (such as CAR-T); Except subjects with evidence that previous allogeneic cell and gene therapy products (such as CAR-positive T cells and CAR transgenes) in the subject have been below the lower limit of detection;
  • Previously received allogeneic hematopoietic stem cell transplantation;
  • Previously received gene therapy;
  • Donor specific antibody (DSA) positive subjects will be excluded;
  • Severe underlying diseases;
  • Hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C virus ribonucleic acid (HCV RNA) or human immunodeficiency virus antibody (HIV-Ab) positive;
  • Presence of other serious pre-existing medical conditions that may limit patient participation in the study. Any condition that, in the investigator's judgment, will make the subject unsuitable for participation in this study.

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: Each subject will receive LUCAR-20SP cells
Chimeric antigen receptor T cells LUCAR-20SP cells
Biological: LUCAR-20SP cells
Prior to infusion of the LUCAR-20SP, 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
Dose-limiting toxicity (DLT) rate
Time Frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)
DLT refers to a drug-related toxicity during treatment with the drug, the severity of which is clinically unacceptable, limiting the further escalation of drug dose.
Minimum 2 years after LUCAR-20SP infusion (Day 1)
Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
Time Frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)
An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment.
Minimum 2 years after LUCAR-20SP infusion (Day 1)
Recommended Phase 2 Dose (RP2D) regimen finding
Time Frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)
RP2D established through accelerated titration design (ATD) and Bayesian Optimal Interval (BOIN) design.
Minimum 2 years after LUCAR-20SP infusion (Day 1)
Pharmacokinetics in peripheral blood
Time Frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)
CAR transgene levels in peripheral blood after LUCAR-20SP infusion. CAR positive T cells levels in bone marrow after LUCAR-20SP infusion.
Minimum 2 years after LUCAR-20SP infusion (Day 1)
Pharmacokinetics in bone marrow
Time Frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)
CAR positive T cells levels in bone marrow after LUCAR-20SP infusion. CAR transgene levels in bone marrow after LUCAR-20SP infusion.
Minimum 2 years after LUCAR-20SP infusion (Day 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) after administration
Time Frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)
ORR is defined as the proportion of subjects who achieve complete response (CR) or partial response (PR) after treatment via LUCAR-20SP cell infusion, and the objective tumor response rate will be calculated for patients with measurable disease per the Lugano Classification for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma (Lugano 2014)
Minimum 2 years after LUCAR-20SP infusion (Day 1)
Time to Response (TTR) after administration
Time Frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)
TTR is defined as the time from the date of first infusion of LUCAR-20SP to the date of the first response evaluation of the subject who has met all criteria for PR or better.
Minimum 2 years after LUCAR-20SP infusion (Day 1)
Duration of Remission (DoR) after administration
Time Frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)
DoR is defined as the time from the first documentation of remission (PR or better) to the first documented disease progression evidence (according to Lugano 2014) of the responders (who achieve PR or better response).
Minimum 2 years after LUCAR-20SP infusion (Day 1)
Progression-free Survival (PFS) after administration
Time Frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)]
PFS is defined as the time from the date of first infusion of the LUCAR-20SP to the first documented disease progression (according to Lugano 2014) or death (due to any cause), whichever occurs first.
Minimum 2 years after LUCAR-20SP infusion (Day 1)]
Overall Survival (OS) after administration
Time Frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)]
OS is defined as the time from the date of first infusion of LUCAR-20SP to death of the subject.
Minimum 2 years after LUCAR-20SP infusion (Day 1)]
Incidence of anti-LUCAR-20SP antibody
Time Frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)
The incidence of anti-LUCAR-20SP antibody in patients who received LUCAR-20SP infusion.
Minimum 2 years after LUCAR-20SP infusion (Day 1)

Collaborators and Investigators

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

Sponsor

Peking University Cancer Hospital & Institute

Collaborators

Henan Cancer Hospital
Beijing Boren Hospital
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)

March 14, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

March 10, 2024

First Submitted That Met QC Criteria

March 10, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 20, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LB2302-0001

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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