RecruitingPhase 2NCT07077512

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

A Single-arm, Phase II Clinical Study of Relmacabtagene Autoleucel Combined With Sintilimab for Relapsed/Refractory B-cell Lymphoma.


Sponsor

Sun Yat-sen University

Enrollment

30 participants

Start Date

Sep 15, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria9

  • The patient must be aware of and voluntarily sign the informed consent form (ICF).
  • Aged between 18 and 70 years, both male and female.
  • Pathologically diagnosed with DLBCL, FL, or MCL, with histological confirmation of CD19 positivity (immunohistochemistry or flow cytometry, with flow cytometry used for re-evaluation if immunohistochemistry is CD19-negative).
  • The patient must be willing to receive regorafenib and sintilimab treatment and be deemed suitable for this treatment by the investigator.
  • Relapsed/refractory DLBCL, FL, or MCL.
  • At least one measurable or evaluable lesion.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
  • Expected survival of ≥3 months.
  • Adequate function of the heart, lungs, liver, kidneys, and other organs.

Exclusion Criteria13

  • History of another malignancy that has not been in complete remission for at least 2 years, except for: non-melanoma skin cancer, completely resected stage I tumors with low recurrence potential, treated localized prostate cancer, biopsy-confirmed cervical carcinoma in situ, or squamous intraepithelial lesions detected by Pap smear and so on.
  • Active Hepatitis B: a) Positive for Hepatitis B surface antigen (HBsAg) and/or Hepatitis B core antibody (HBcAb) , with HBV-DNA below the lower limit of the reference value can be included.
  • Hepatitis C, HIV, or syphilis infection.
  • Uncontrolled systemic fungal, bacterial, viral, or other infections.
  • Acute or chronic graft-versus-host disease (GVHD).
  • Known hypersensitivity or allergy to any study drug or excipient.
  • Clinically significant central nervous system (CNS) disease or symptoms, such as epilepsy, seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychiatric illness.
  • Pregnant or breastfeeding women, and women of childbearing age who do not wish to use contraception.
  • Mentally ill individuals or those unable to provide informed consent.
  • The investigator deems the patient unsuitable for the study due to medical, psychological, familial, social, or geographical reasons or an inability to comply with the study protocol.
  • Previous CAR-T cell therapy or other gene-modified T-cell treatments.
  • Previous CD19-targeted therapy.
  • Previous allogeneic hematopoietic stem cell transplantation.

Interventions

DRUGAutoleucel (Relmacabtagene Autoleucel)

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

DRUGSintilimab (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.


Locations(3)

Sun Yat-sen Universitiy Cancer Center

Guangzhou, China

Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Guangzhou overseas Chinese hospital

Guangzhou, China

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NCT07077512


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