NCT06313957

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
28mo left

Started Mar 2024

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Mar 2024Sep 2028

First Submitted

Initial submission to the registry

March 10, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

March 14, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

2.5 years

First QC Date

March 10, 2024

Last Update Submit

March 20, 2025

Conditions

Relapsed B-cell Non-Hodgkin LymphomaRefractory B-cell Non-Hodgkin Lymphoma

Keywords

Relapsed B-cell non-Hodgkin lymphomaRefractory B-cell non-Hodgkin lymphoma

Outcome Measures

Primary Outcomes (5)

  • 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 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

    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 Outcomes (6)

  • Objective Response Rate (ORR) after administration

    Minimum 2 years after LUCAR-20SP infusion (Day 1)

  • Time to Response (TTR) after administration

    Minimum 2 years after LUCAR-20SP infusion (Day 1)

  • Duration of Remission (DoR) after administration

    Minimum 2 years after LUCAR-20SP infusion (Day 1)

  • Progression-free Survival (PFS) after administration

    Minimum 2 years after LUCAR-20SP infusion (Day 1)]

  • Overall Survival (OS) after administration

    Minimum 2 years after LUCAR-20SP infusion (Day 1)]

  • +1 more secondary outcomes

Study Arms (1)

Each subject will receive LUCAR-20SP cells

EXPERIMENTAL

Chimeric antigen receptor T cells LUCAR-20SP cells

Biological: LUCAR-20SP cells

Interventions

LUCAR-20SP cellsBIOLOGICAL

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

Each subject will receive LUCAR-20SP cells

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Beijing GoBroad Boren Hospital

Beijing, Beijing Municipality, 100070, China

RECRUITING

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, 100142, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Yuqin Song

CONTACT

13683398726songyq22622@163.com

Yan Xie

CONTACT

13671376201xieyan9@263.net

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2024

First Posted

March 15, 2024

Study Start

March 14, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2028

Last Updated

March 25, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(3)