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

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: Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
• Intervention / Treatment: Biological: LUCAR-20SP cells

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

• Study Contact: Name: Yuqin Song; Phone Number: 13683398726; Email: songyq22622@163.com
• Study Contact Backup: Name: Yan Xie; Phone Number: 13671376201; Email: xieyan9@263.net

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Peking University Cancer Hospital & Institute
      • Principal Investigator: Yuqin Song
      • Contact: Yuqin Song; Phone Number: 13683398726; Email: songyq22622@163.com
      • Contact: Yan Xie; Phone Number: 13671376201; Email: xieyan9@263.net

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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)	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	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	CAR positive T cells and CAR transgene levels in peripheral blood after LUCAR-20SP infusion	Minimum 2 years after LUCAR-20SP infusion (Day 1)
Pharmacokinetics in bone marrow	CAR positive T cells and 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	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	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	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	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	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	Venous blood samples will be collected to measure LUCAR-20SP positive cell concentrations and the transgenic level of LUCAR-20SP, at the time points when anti-LUCAR-20SP antibody serum samples are evaluated.	Minimum 2 years after LUCAR-20SP infusion (Day 1)

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 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 15, 2024
• Last Update Submitted That Met QC Criteria: March 10, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Relapsed/refractory B-cell non-Hodgkin lymphoma
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin
• 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