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

NCT06733051 | Recruiting Phase 2

• 1 other identifier: B2024-736-01
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 2

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.

Conditions

Natural Killer T-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate(ORR)

  The proportion of patients who achieve complete remission (CR) or partial remission (PR) as the best response.

  2 years

Secondary Outcomes (5)

• Complete Response(CR)

  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

• Incidence and severity of adverse events (AE) , Serious adverse event (SAE) and immune-related adverse event (irAE)

  Through study completion, up tp 2 years.

Study Arms (1)

Golidocitinib and Benmelstobart Combination

EXPERIMENTAL

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.

Drug: Golidocitinib; Drug: Benmelstobart

Interventions

Golidocitinib DRUG

150 mg, administered once daily from Day 1 to Day 21 (D1-D21)

Golidocitinib and Benmelstobart Combination

Benmelstobart DRUG

1200 mg, administered on Day 1 (D1) of every cycle

Golidocitinib and Benmelstobart Combination

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (2)

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Central Study Contacts

Qingqing Cai, MD. PhD.

CONTACT

0086-20-87342823; caiqq@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. PhD.

Study Record Dates

• First Submitted: December 8, 2024
• First Posted: December 13, 2024
• Study Start: January 27, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 10, 2025

Record last verified: 2025-02

Locations

CN (2)