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

Recruiting now · Phase 2

Conditions studied: Large B Cell Diffuse Lymphoma, Mantle Cell Lymphoma (MCL), Follicular Lymphoma ( FL)

In brief

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

Key facts

Study ID

NCT07077512

Run by

Sun Yat-sen University

People needed

30

Starts

2025-09-15

Expected to finish

2027-07-15

Last updated by the study team

2026-01-21

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Sun Yat-sen Universitiy Cancer Center — Guangzhou, China (enrolling)
• Fifth Affiliated Hospital of Guangzhou Medical University — Guangzhou, China
• Guangzhou overseas Chinese hospital — Guangzhou, China

Full record on ClinicalTrials.gov

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