Clinical trial NCT06313957: A Study of LUCAR-20SP in Subjects With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Relapsed B-cell Non-Hodgkin Lymphoma
Refractory B-cell Non-Hodgkin Lymphoma
Keywords: Relapsed B-cell non-Hodgkin lymphoma
Refractory B-cell non-Hodgkin lymphoma
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
Collaborators: name: Nanjing Legend Biotech Co.
name: Beijing Boren Hospital
name: Henan Cancer Hospital
First posted: 2024-03-15
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Dose-limiting toxicity (DLT) rate
timeFrame: Minimum 2 years after LUCAR-20SP infusion (Day 1)
measure: Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
timeFrame: Minimum 2 years after LUCAR-20SP infusion (Day 1)
measure: Recommended Phase 2 Dose (RP2D) regimen finding
timeFrame: Minimum 2 years after LUCAR-20SP infusion (Day 1)
measure: Pharmacokinetics in peripheral blood
timeFrame: Minimum 2 years after LUCAR-20SP infusion (Day 1)
measure: Pharmacokinetics in bone marrow
timeFrame: Minimum 2 years after LUCAR-20SP infusion (Day 1)
Secondary outcomes:
measure: Objective Response Rate (ORR) after administration
timeFrame: Minimum 2 years after LUCAR-20SP infusion (Day 1)
measure: Time to Response (TTR) after administration
timeFrame: Minimum 2 years after LUCAR-20SP infusion (Day 1)
measure: Duration of Remission (DoR) after administration
timeFrame: Minimum 2 years after LUCAR-20SP infusion (Day 1)
measure: Progression-free Survival (PFS) after administration
timeFrame: Minimum 2 years after LUCAR-20SP infusion (Day 1)]
measure: Overall Survival (OS) after administration
timeFrame: Minimum 2 years after LUCAR-20SP infusion (Day 1)]
measure: Incidence of anti-LUCAR-20SP antibody
timeFrame: Minimum 2 years after LUCAR-20SP infusion (Day 1)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing GoBroad Boren Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Cancer Hospital & Institute
state: Beijing
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
Study officials:
References: