Phase II Study of Golidocitinib and Benmelstobart in Patients with R/R ENKTL (JACKPOT50)

Phase 2

Recruiting

• Conditions: Natural Killer T-cell Lymphoma
• Interventions: Drug: Golidocitinib; Drug: Benmelstobart

• Registration Number: NCT06733051
• Lead Sponsor: Sun Yat-sen University

Brief Summary

This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of golidocitinib and benmelstobart combination treatment in patients with relapsed or refractory extranodal natural killer/T cell lymphoma.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-27
• Study First Submitted: 2024-12-08
• Study First Submitted QC: 2024-12-12
• Study First Posted: 2024-12-13
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-10
• Primary Completion: 2026-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

1. Subjects fully understand and voluntarily participate in this study and sign informed consent.
2. Pathologically confirmed extranodal natural killer/T cell lymphoma (ENKTL).
3. Age ≥18, no gender limitation.
4. Treatment failure to at least one line of asparaginase-based therapy.
5. Eastern Cooperative Oncology Group performance status of 0-2
6. Expected survival ≥ 3 months.
7. At least one measurable lesion that meets Lugano 2014 criteria.
8. Sufficient organ function.

Exclusion Criteria

1. Invasive NK-cell leukemia or NKTCL that has progressed to leukemia.
2. Accompanied by hemophagocytic lymphohistiocytosis.
3. NKTCL with central nervous system invasion.
4. Previously treated with JAK inhibitors.
5. The patients have contraindications to any drug in the combined treatment.
6. Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome.
7. Inability to swallow tablets, presence of malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may affect the absorption of the study drug.
8. Pregnant and lactating women and subjects of childbearing age who do not want to use contraception.
9. Mentally ill persons or persons unable to obtain informed consent. The investigators think that the patient is not suitable for the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Golidocitinib and Benmelstobart Combination	Benmelstobart	Patients will receive golidocitinib in combination with benmelstobart every 3 weeks for up to 24 months, until disease progression, unaccpetable toxicities or other reasons lead to discontinuation.
Golidocitinib and Benmelstobart Combination	Golidocitinib	Patients will receive golidocitinib in combination with benmelstobart every 3 weeks for up to 24 months, until disease progression, unaccpetable toxicities or other reasons lead to discontinuation.

Primary Outcome Measures

Name	Time	Method
Objective response rate(ORR)	2 years	The proportion of patients who achieve complete remission (CR) or partial remission (PR) as the best response.

Secondary Outcome Measures

Name	Time	Method
Complete Response(CR)	2 years	Defined as the proportion of patients who achieve complete remission as the best response
Duration of Response(DOR)	Up to 4 years	To investigate the preliminary anti-tumor efficacy
Progression-free survival(PFS)	Up to 4 years	To investigate the preliminary anti-tumor efficacy
Overall survival(OS)	Up to 4 years	To investigate the preliminary anti-tumor efficacy
Incidence and severity of adverse events (AE) , Serious adverse event (SAE) and immune-related adverse event (irAE)	Through study completion, up tp 2 years.	To identify the incidence of AE, SAE, and irAE.

Trial Locations

Locations (2)

Beijing Tongren Hospital; 🇨🇳 Beijing, Beijing, China

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China