NCT04052659 is a Phase 2 clinical trial of Sintilimab in Peripheral T-cell Lymphoma, sponsored by Peking University.

Who is sponsoring NCT04052659?

NCT04052659 is sponsored by Peking University.

What drugs are being tested in NCT04052659?

Interventions in NCT04052659: Sintilimab, Chidamide, Azacidine.

What condition does NCT04052659 study?

NCT04052659 studies Peripheral T-cell Lymphoma.

Is NCT04052659 still recruiting?

NCT04052659 is currently status unknown. Last updated 9 March 2021.

Last reviewed 2021-03-09 · How we verify

NCT04052659

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Sintilimab (IBI308) in Combination With Chidamide and Azacitidine in Refractory or Relapsed PTCL

Status unknown Phase 2 Last updated 9 March 2021

What this trial tests

Phase 2 trial testing Sintilimab in Peripheral T-cell Lymphoma in 30 participants. Status unknown.

Timeline

15 April 2021

Primary endpoint
30 December 2024

30 December 2025

Quick facts

Lead sponsor	Peking University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	15 April 2021
Primary completion	30 December 2024
Estimated completion	30 December 2025
Sites	1 location across China

Drugs / interventions tested

Sintilimab — full drug profile →
Chidamide — full drug profile →
Azacidine — full drug profile →

Conditions studied

Peripheral T-cell Lymphoma — all drugs for Peripheral T-cell Lymphoma →

Sponsor

Peking University

Who can join

Adults 18 to 80, any sex, with Peripheral T-cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a single-arm, single-center Phase II clinical trial for patients with relapsed or refractory Peripheral T-cell lymphoma (PTCL). Immunotherapy with anti-PD-1 antibodies, such as sintilimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chidamide and azacitidine may respectively stop the growth of tumor cells by blocking histone deacetylation and DNA methylation enzymes needed for cell growth. Giving chidamide and azacitidine with sintilimab these three drugs may work better than single drug or combination of two drugs in treating patients with relapsed or refractory peripheral T-cell lymphoma.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Epigenetic regulation in hematopoiesis and its implications in the targeted therapy of hematologic malignancies.
Zhao A, Zhou H, Yang J, Li M, et al · · 2023 · cited 81× · PMID 36797244 · DOI 10.1038/s41392-023-01342-6
Revolutionization in Cancer Therapeutics via Targeting Major Immune Checkpoints PD-1, PD-L1 and CTLA-4.
Pandey P, Khan F, Qari HA, Upadhyay TK, et al · · 2022 · cited 67× · PMID 35337133 · DOI 10.3390/ph15030335
Therapeutic potential of tucidinostat, a subtype-selective HDAC inhibitor, in cancer treatment.
Sun Y, Hong JH, Ning Z, Pan D, et al · · 2022 · cited 58× · PMID 36120308 · DOI 10.3389/fphar.2022.932914
Recent updates on Sintilimab in solid tumor immunotherapy.
Liu X, Yi Y. · · 2020 · cited 35× · PMID 33292551 · DOI 10.1186/s40364-020-00250-z
Primary CNS lymphoma commonly expresses immune response biomarkers.
Ou A, Sumrall A, Phuphanich S, Spetzler D, et al · · 2020 · cited 34× · PMID 32201861 · DOI 10.1093/noajnl/vdaa018
Epi-immunotherapy for cancers: rationales of epi-drugs in combination with immunotherapy and advances in clinical trials.
Xu Y, Li P, Liu Y, Xin D, et al · · 2022 · cited 29× · PMID 35642676 · DOI 10.1002/cac2.12313
Converting "cold" to "hot": epigenetics strategies to improve immune therapy effect by regulating tumor-associated immune suppressive cells.
Tang Y, Cui G, Liu H, Han Y, et al · · 2024 · cited 28× · PMID 38715348 · DOI 10.1002/cac2.12546
Treatment Advances in EBV Related Lymphoproliferative Diseases.
Lv K, Yin T, Yu M, Chen Z, et al · · 2022 · cited 14× · PMID 35515118 · DOI 10.3389/fonc.2022.838817

Verify or expand the search:

Other trials of Sintilimab

Trials testing the same drug.

NCT07535632 — SBRT Followed by PD-1 Inhibitor, Bevacizumab and TAS-102 as Third-Line Therapy for Recurrent/Metastatic Colorectal Cance · Phase 2 · not yet recruiting
NCT07537946 — Local Consolidation After Sintilimab Plus Lenvatinib for Metastatic Liver Cancer · Phase 3 · not yet recruiting
NCT07537972 — Denosumab Strategy for Liver Cancer With Bone Metastases · Phase 2 · not yet recruiting
NCT07468630 — Tolecizumab Plus Chemoimmunotherapy for pMMR/MSS Locally Advanced Colon Adenocarcinoma · Phase 2 · recruiting
NCT07515625 — Efficacy of Sintilimab Combined With Bevacizumab and XELOX/SOX in Initially Unresectable AFP-positive Gastric/Gastroesop · Phase 2 · not yet recruiting

Other recruiting trials for Peripheral T-cell Lymphoma

Currently open trials in the same condition.

NCT07523555 — Adaptive Dual-Target CAR-T Cells for Relapsed or Refractory Hematologic Malignancies · Phase 1, PHASE2 · recruiting
NCT06176690 — Constitutive IL7R (C7R) Modified Banked Allogeneic CD30.CAR EBVSTS for CD30-Positive Lymphomas · Phase 1 · recruiting
NCT06914037 — A Clinical Study of CHT101 in CD70-Positive Relapsed or Refractory Hematological Malignancies · Phase 1 · recruiting
NCT07072221 — Bendamustine Combined With Chidamide and Lenalidomide for Relapsed and Refractory PTCL Patients · NA · recruiting
NCT06739265 — Golidocitinib Plus CHOP in Newly Diagnosed PTCL · Phase 1, PHASE2 · recruiting

Other Peking University trials

Trials by the same sponsor.

NCT07519122 — Fangshan Active Nutrition Initiative · NA · not yet recruiting
NCT07466238 — HAIC Plus Systemic Therapy as De-escalation Therapy Strategy for Biliary Tract Cancer · NA · recruiting
NCT07480525 — Efficacy and Mechanisms of Escitalopram in Drug-Naïve First-Episode Major Depressive Disorder · NA · not yet recruiting
NCT07454031 — Intraperitoneal PX in Combination With Nab-Paclitaxel in Patients With Peritoneal Metastatic Mucinous Adenocarcinoma · Phase 1 · not yet recruiting
NCT07466225 — HAIC Plus Lenva and PD-1 for Advanced HCC With Macrovascular or Biliary Invasion · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04052659 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Peking University
Last refreshed: 9 March 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04052659.

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