Adebrelimab Combined With SHR2554 in Relapsed/Refractory PTCL and NK/T-Cell Lymphoma
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years old,regardless of gender;
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;
Disqualifiers
Pregnant or lactating women;
Patients with hemophagocytic lymphohistiocytosis;
Primary central nervous system (CNS) lymphoma or secondary CNS involvement.
History of allogeneic organ transplantation;
Trial design
Design model
Single group
Treatments tested in this trial
Adebrelimab & SHR2554
Drug①Phase 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Adebrelimab combined with SHR2554Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Phase Ib: Dose limited toxicities (DLTs)
Adverse events (AE) defined as DLT events per protocol
Time frame
Cycle 1 (21 days)2
Phase Ib: Recommended Phase II Dose (RP2D)
RP2D based on Phase Ib results
Time frame
through Phase Ib study completion, an average of 4 months3
Objective response rate (ORR)
Response is assessed according to the 2014 lugano criteria
Time frame
Up to 2 yearsSecondary outcomes
1
Complete response rate (CRR)
Response is assessed according to the 2014 lugano criteria
Time frame
Up to 2 years2
Duration of Response (DOR)
Response is assessed according to the 2014 lugano criteria
Time frame
Up to 4 years3
Progression-free survival（PFS）
From the time subjects were enrolled to the time of disease progression (in any way) or death from any cause.
Time frame
Up to 4 years4
Overall survival (OS)
From the date of inclusion to date of death, irrespective of cause.
Time frame
Up to 4 yearsSponsors and contacts
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Source ClinicalTrials.gov
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