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Relmacabtagene Autoleucel Combined With Sintilimab for Relapsed/Refractory B-cell Lymphoma

NCT07077512 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-01-21

No results posted yet for this study

Summary

This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of Relmacabtagene Autoleucel in combination with the Sintilimab regimen for the treatment of relapsed/refractory B-cell lymphoma

Conditions

  • Large B Cell Diffuse Lymphoma
  • Mantle Cell Lymphoma (MCL)
  • Follicular Lymphoma ( FL)

Interventions

DRUG

Autoleucel (Relmacabtagene Autoleucel)

Relmacabtagene Autoleucel will be reinfused 2 to 7 days after lymphodepletion (fludarabine + cyclophosphamide).

DRUG

Sintilimab (PD-1 inhibitor)

Patients will receive intravenous Sintilimab (200 mg every 3 weeks) starting on Day 28 after reinfusion, continuing until disease progression or intolerable toxicity, with a maximum duration of 1 year.

Sponsors & Collaborators

  • Fifth Affiliated Hospital of Guangzhou Medical University

    collaborator OTHER

  • Guangzhou Overseas Chinese Hospital,Guangdong

    collaborator UNKNOWN

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2027-01-15
Completion
2027-07-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07077512 on ClinicalTrials.gov