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

Refractory B-cell Non-Hodgkin Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06313957
• Other study ID #: LB2302-0001
• Status: Recruiting
• Phase: Phase 1
• Start date: March 14, 2024
• Est. completion date: September 2028

Study information

• Verified date: March 2024
• Source: Peking University Cancer Hospital & Institute
• Contact: Yuqin Song
• Phone: 13683398726
• Email: songyq22622[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: September 2028
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin
• Refractory B-cell Non-Hodgkin Lymphoma
• Relapsed B-cell Non-Hodgkin Lymphoma

Intervention

Biological:
• LUCAR-20SP cells
Prior to infusion of the LUCAR-20SP, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.

Locations

Country	Name	City	State
China	Peking University Cancer Hospital & Institute	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University Cancer Hospital & Institute	Nanjing Legend Biotech Co.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	Pharmacokinetics in peripheral blood	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)
Primary	Pharmacokinetics in bone marrow	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	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)
Secondary	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)
Secondary	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)
Secondary	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)]
Secondary	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)]
Secondary	Incidence of anti-LUCAR-20SP antibody	The incidence of anti-LUCAR-20SP antibody in patients who received LUCAR-20SP infusion.	Minimum 2 years after LUCAR-20SP infusion (Day 1)