A Study of LUCAR-20SP in Subjects With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University Cancer Hospital & Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
LUCAR-20SP cells
Biological/VaccinePrior to infusion of the LUCAR-20SP, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.
Treatment groups
42 Participants
are divided into 1 treatment groupGroup A: Each subject will receive LUCAR-20SP cellsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Minimum 2 years after LUCAR-20SP infusion (Day 1)2
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.
Time frame
Minimum 2 years after LUCAR-20SP infusion (Day 1)3
Recommended Phase 2 Dose (RP2D) regimen finding
RP2D established through accelerated titration design (ATD) and Bayesian Optimal Interval (BOIN) design.
Time frame
Minimum 2 years after LUCAR-20SP infusion (Day 1)4
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.
Time frame
Minimum 2 years after LUCAR-20SP infusion (Day 1)Secondary outcomes
1
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)
Time frame
Minimum 2 years after LUCAR-20SP infusion (Day 1)2
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.
Time frame
Minimum 2 years after LUCAR-20SP infusion (Day 1)3
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).
Time frame
Minimum 2 years after LUCAR-20SP infusion (Day 1)4
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.
Time frame
Minimum 2 years after LUCAR-20SP infusion (Day 1)]Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Peking University Cancer Hospital & Institute
Lead sponsor
Nanjing Legend Biotech Co.
Collaborator
Beijing Boren Hospital
Collaborator
Henan Cancer Hospital
Collaborator
Source ClinicalTrials.gov