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

NCT07077512 | Recruiting Phase 2

• 1 other identifier: B2025-263-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief 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

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

Keywords

Relmacabtagene Autoleucel; Sintilimab; CD19 Positive; B cell lymphoma

Outcome Measures

Primary Outcomes (1)

• The complete response rate (CRR) at 3 months

  Up to 3 months after Relmacabtagene Autoleucel infusion

Secondary Outcomes (5)

• Disease-free survival (DFS)

  From the date of the first complete response to the date of the first documented progression or death from any cause, whichever came first,assessed up to 24 months

• Progression-free survival (PFS)

  From the date of enrollment until the date of the first documented progression or death from any cause,whichever came first,assessed up to 24 months

• Overall survival (OS)

  From the date of enrollment until the date of death from any cause, assessed up to 24 months

• Number of participants with adverse events (AE) and severe adverse events (SAE) as assessed by CTCAE v5.0

  Through study completion, an average of 2 years

• Objective Response Rate

  Up to 1 year after Relmacabtagene Autoleucel infusion

Other Outcomes (1)

• Investigating Immune Microenvironment, Proteomic, and Metabolomic Changes Associated with Treatment Efficacy Across Different Patient Group

  Through study completion, an average of 2 years

Study Arms (1)

Relmacabtagene Autoleucel in combination with Sintilimab

EXPERIMENTAL

Patients with CD19-positive relapsed/refractory B-cell lymphoma will receive Relmacabtagene Autoleucel after lymphodepletion therapy (fludarabine + cyclophosphamide) on Day 1. After Relmacabtagene Autoleucel infusion, sintilimab (200 mg IV) will begin on Day 28, administered every 3 weeks until disease progression or intolerable toxicity, with a maximum duration of 1 year.

Drug: Autoleucel (Relmacabtagene Autoleucel); Drug: Sintilimab (PD-1 inhibitor)

Interventions

Sintilimab (PD-1 inhibitor) DRUG

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.

Also known as: PD-1 Inhibitor

Relmacabtagene Autoleucel in combination with Sintilimab

Autoleucel (Relmacabtagene Autoleucel) DRUG

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

Also known as: Chimeric Antigen Receptor T-Cell (CAR-T) Therapy

Relmacabtagene Autoleucel in combination with Sintilimab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Fifth Affiliated Hospital of Guangzhou Medical University: collaborator
• Guangzhou Overseas Chinese Hospital,Guangdong: collaborator
• Sun Yat-sen University: lead

Study Sites (3)

Sun Yat-sen Universitiy Cancer Center

Guangzhou, 51000, China

RECRUITING

Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, 510060, China

NOT YET RECRUITING

Guangzhou overseas Chinese hospital

Guangzhou, 510632, China

NOT YET RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Lymphoma, Mantle-Cell; Lymphoma, Follicular; Lymphoma, B-Cell

Interventions

relmacabtagene autoleucel; Therapeutics; sintilimab; Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Central Study Contacts

Qingqing Cai, MD. PhD

CONTACT

02087342823; caiqq@sysucc.org.cn

Yi Xia, MD. PhD

CONTACT

02087342823; xiayi@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 22, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): July 15, 2027
• Last Updated: January 21, 2026

Record last verified: 2025-06

Locations

CN (3)