NCT05316246

Efficacy and Safety of BV With Tislelizumab for the Treatment of CD30+ Relapsed/Refractory NK/T-cell Lymphoma

Status unknown Phase 2 Last updated 7 April 2022

What this trial tests

Phase 2 trial testing Brentuximab Vedotin in Combination with Tislelizumab in NK/T Cell Lymphoma Nos in 40 participants. Status unknown.

Timeline

1 June 2022

Primary endpoint
1 June 2024

31 December 2024

Quick facts

Lead sponsor	Shanghai Zhongshan Hospital
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	1 June 2022
Primary completion	1 June 2024
Estimated completion	31 December 2024

Drugs / interventions tested

• Brentuximab Vedotin in Combination with Tislelizumab — full drug profile →

Conditions studied

• NK/T Cell Lymphoma Nos — all drugs for NK/T Cell Lymphoma Nos →

Sponsor

Shanghai Zhongshan Hospital

Who can join

Adults 18 to 75, any sex, with NK/T Cell Lymphoma Nos. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a single-arm, open-label, multicenter, phase 2 study designed to evaluate the efficacy and safety of brentuximab vedotin combined with PD-1 inhibitor tislelizumab in Chinese patients with relapsed/refractory CD30+ NK/CL. Brentuximab vedotin will be administered as 1.8 mg/kg IV infusion on Day 1 of each 3-week cycle. PD-1 inhibitor tislelizumab will be administered as 200 mg on Day 1 of each 3-week cycle. Patients will receive maximum of 8 cycles if they do not meet the criteria for removal from the study. Patients will be assessed for overall response using the Revised Response Criteria for Malignant Lymphoma (Lugano 2014). Dedicated computed tomography (CT) scans (neck, chest, abdomen, and pelvis) will be performed at Baseline and at Cycles 2, 4 and 8, and positron emission tomography (PET) scans will be performed at Baseline and at Cycles 4 and 8. No additional PET scanning is required beyond Cycle 8 unless clinically indicated (for example, suspected of disease progression). The disease symptoms will be assessed at Baseline and on Day 1 of each cycle. Patients may continue study treatment until the sooner of disease progression, unacceptable toxicity, or completion of 8 cycles. Patients who discontinue study treatment for any reason other than withdrawal of consent will have safety follow-up assessments through 30 days after the last dose of 、study drug (end of treatment \[EOT\]). Patients who discontinue study treatment with stable disease (SD), responses and progression disease (PD) will be followed for 1-year PFS rate and 1-year OS rate. The CT scan, PET-CT and laboratory examination will be followed based on clinical practice. The study will be closed when all patients enrolled have completed the required follow-up.Toxicity will be evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0 Laboratory values, vital signs, and electrocardiograms (ECGs) will be obtained to evaluate the safety and tolerability of study treatment.

Publications & conference data

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

1. Current trends in sensitizing immune checkpoint inhibitors for cancer treatment.
   Wei J, Li W, Zhang P, Guo F, et al · · 2024 · cited 82× · PMID 39725966 · DOI 10.1186/s12943-024-02179-5
2. Treatment of extranodal NK/T-cell lymphoma: From past to future.
   Yan Z, Yao S, Wang Z, Zhou W, et al · · 2023 · cited 22× · PMID 36825002 · DOI 10.3389/fimmu.2023.1088685
3. The progress of novel strategies on immune-based therapy in relapsed or refractory diffuse large B-cell lymphoma.
   Lu T, Zhang J, Xu-Monette ZY, Young KH. · · 2023 · cited 19× · PMID 37580826 · DOI 10.1186/s40164-023-00432-z
4. Antibody-Drug Conjugates Targeting CD30 in T-Cell Lymphomas: Clinical Progression and Mechanism.
   Jiang Y, Dong S, Wang Y. · · 2025 · cited 5× · PMID 39941862 · DOI 10.3390/cancers17030496
5. Education and Empowering Special Forces to Eradicate Secret Defectors: Immune System-Based Treatment Approaches for Mature T- and NK-Cell Malignancies.
   Braun T, Schrader A. · · 2023 · cited 2× · PMID 37173999 · DOI 10.3390/cancers15092532
6. Antibody-Based Therapies for Peripheral T-Cell Lymphoma.
   Shafagati N, Paul S, Rozati S, Sterling CH. · · 2024 · PMID 39456582 · DOI 10.3390/cancers16203489