Adebrelimab Combined With SHR2554 in Relapsed/Refractory PTCL and NK/T-Cell Lymphoma

NCT07615283 | Not Yet Recruiting Phase 1

• 1 other identifier: B2026-063-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety of adebrelimab combined with SHR2554 in the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL) and NK/T-cell lymphoma (NKTCL), to determine the recommended Phase 2 dose (RP2D) of the combination regimen, and to assess preliminary efficacy.

Conditions

NKTCL; Relapsed or Refractory Peripheral T Cell Lymphoma

Keywords

SHR2554; adebrelimab; EZH2 inhibitor

Outcome Measures

Primary Outcomes (3)

• Phase Ib: Dose limited toxicities (DLTs)

  Adverse events (AE) defined as DLT events per protocol

  Cycle 1 (21 days)

• Phase Ib: Recommended Phase II Dose (RP2D)

  RP2D based on Phase Ib results

  through Phase Ib study completion, an average of 4 months

• Objective response rate (ORR)

  Response is assessed according to the 2014 lugano criteria

  Up to 2 years

Secondary Outcomes (6)

• Complete response rate (CRR)

  Up to 2 years

• Duration of Response (DOR)

  Up to 4 years

• Progression-free survival（PFS）

  Up to 4 years

• Overall survival (OS)

  Up to 4 years

• Adverse events(AE)

  From the first day of medication to 28 days after the last dose

Study Arms (1)

Adebrelimab combined with SHR2554

EXPERIMENTAL

Drug: Adebrelimab & SHR2554

Interventions

Adebrelimab & SHR2554 DRUG

①Phase Ib : SHR2554 350 mg twice daily ; Adebrelimab 1200 mg, IV infusion for 1 cycle(21days) ②Phase II ：Adebrelimab RP2D (600 mg or 1200 mg ), IV infusion ,D1 Q3W ; SHR2554 : 350 mg，twice daily ; Up to 6 cycles. ③Maintenance therapy : SHR2554 350 mg，twice daily (28 days per cycle) ,not exceed 24 months.

Adebrelimab combined with SHR2554

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years old,regardless of gender;
• Centrally confirmed histopathological/cytologic diagnosis of PTCL with the following subtypes:
• Peripheral T-cell lymphoma, not otherwise specified (PTCL, NOS);
• Systemic anaplastic large cell lymphoma (ALK+ and ALK-);
• Follicular helper T (TFH) cell lymphoma of lymph nodes, including angioimmunoblastic, follicular, NOS;
• NKTCL
• Met the criteria of relapsed/refractory lymphoma: Relapsed lymphoma was defined as relapsed lymphoma after achieving complete response (CR) or partial response(PR)after initial therapy. Refractory is defined as having an evaluation of progressive disease (PD) after 2 cycles, or stable disease (SD) after 4 cycles of a previous systemic therapy regimen.
• There must be at least one measurable or evaluable lesion that meets the Lugano 2014 criteria for lymphoma: Measurable lesion: Nodal lesions with major diameter greater than 1.5cm and minor diameter greater than 1.0cm as assessed by PET/CT or Computed Tomography (CT) and/or Magnetic Resonance Imaging (MRI); Or the length of extranodal lesions \>1.0cm; 2)Evaluable lesions: PET-CT showed increased uptake in lymph nodes or extranodal regions (higher than liver) and imaging features consistent with lymphoma;
• ECOG performance status score: 0-2;
• Expected survival time ≥3 months;
• Have adequate organ and bone marrow function, defined as follows(The patients had not received granulocyte growth factor, platelet transfusion, or red blood cell transfusion within 14 days before the examination):
• Blood routine: absolute neutrophil count (ANC) ≥ 1.0×109/L;
• platelet count (PLT) ≥ 60×109/L;
• hemoglobin (HGB) ≥ 8.0 g/dL;
• white blood cell (WBC) ≥ 3.5×109/L;

You may not qualify if:

• Pregnant or lactating women;
• Patients with hemophagocytic lymphohistiocytosis;
• Primary central nervous system (CNS) lymphoma or secondary CNS involvement.
• History of allogeneic organ transplantation;
• Received allogeneic hematopoietic stem cell transplantation (allo-HSCT) within 3 years prior to the first dose of study drug (patients who received allo-HSCT \> 3 years prior to the first dose of study drug and currently have no active graft-versus-host disease \[GVHD\] are eligible to enroll);
• Known allergy or hypersensitivity to the study drugs or their related metabolites;
• Uncontrolled active infection;
• Currently participating in another clinical study, or less than 4 weeks elapsed from the end of treatment in a previous clinical study to the planned start of study treatment;
• Planned autologous hematopoietic stem cell transplantation (auto-HSCT);
• Less than 3 months elapsed since the last dose of prior treatment with any immune checkpoint inhibitors (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4).
• Active autoimmune disease that required systemic treatment within the past 2 years (hormone replacement therapy is not considered systemic treatment, e.g., type 1 diabetes mellitus, hypothyroidism requiring only thyroxine replacement therapy, or adrenal/pituitary insufficiency requiring only physiologic doses of corticosteroids). Patients with an autoimmune disease that did not require systemic treatment within the past 2 years are eligible to enroll;
• Required systemic treatment with corticosteroids or other immunosuppressive agents for any condition within 14 days prior to the start of study treatment (except for topical or short-term use of corticosteroids, or corticosteroids used for non-autoimmune conditions such as delayed-type hypersensitivity caused by contact allergens);
• Diagnosis of another malignancy within the past 5 years, except for malignancies treated with curative intent, including basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the breast, or carcinoma in situ of the cervix.
• Received systemic anti-tumor therapy within 28 days prior to the start of study treatment, including chemotherapy, immunotherapy, and biological therapy (tumor vaccines, cytokines, or growth factors to control cancer);
• Underwent major surgery within 28 days, or received radiotherapy within 90 days prior to the start of study treatment;

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, China

Location

MeSH Terms

Conditions

Recurrence; Lymphoma, T-Cell, Peripheral

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Huiqiang Huang, M.D

CONTACT

020-87343349; huanghq@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Medical Oncology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start: May 29, 2026
• Primary Completion (Estimated): May 29, 2030
• Study Completion (Estimated): October 29, 2030
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)