AZD4205 in Peripheral T Cell Lymphoma Following First-Line Therapy (JACKPOT26)

NCT06511869 | Completed Phase 2

• 1 other identifier: DZ2021J0005
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 23

Brief Summary

This study is intended to assess the safety and anti-tumor activity of AZD4205 at 150 mg once daily in participants with PTCL who have achieved tumor response after first-line systemic therapy (with or without combination radiotherapy) and are ineligible for HSCT assessed by the investigator as ineligible for HSCT or have no plan for HSCT.

Conditions

Peripheral T-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Adverse events and serious adverse events (graded by CTCAE version 5.0)

  To assess the safety and tolerability of AZD4205 as maintenance/consolidation therapy in PTCL participants achieving tumor response after first-line systemic therapy

  up to 2 years

Secondary Outcomes (6)

• Cohort 1: Disease Free Survival (DFS)

  up to 2 years

• Cohort 1: Disease Free Survival (DFS) rate at 1 year from the first dose of investigational product

  1 year

• Cohort 2: Objective Response Rate (ORR)

  up to 2 years

• Cohort 2: Duration of Response (DoR)

  up to 2 years

• Cohort 2: Progression-free Survival (PFS)

  up to 2 years

Study Arms (1)

AZD4205 treatment

EXPERIMENTAL

Cohort 1: Participants achieving a CR as assessed by the investigator according to Lugano criteria following the first-line systemic therapy. Cohort 2: Participants achieving a PR as assessed by the investigator according to Lugano criteria following the first-line systemic therapy.

Drug: AZD4205

Interventions

AZD4205 DRUG

AZD4205 capsules administered at 150 mg orally, once daily, in 28-day cycle.

AZD4205 treatment

Eligibility Criteria

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

You may qualify if:

• ≥ 18 years old.
• ECOG status score ranging from 0 to 1, without any deterioration in the past two weeks.
• Life expectancy ≥ 3 months.
• Have histopathologically confirmed PTCL that meets the pathological subtypes (except for ALCL-ALK+) as specified in the latest WHO classification of lymphoid neoplasms in 2016.
• Must be assessed to achieve complete or partial response according to Lugano's criteria after first-line systemic standard of therapy:
• The participants should be assessed as ineligible for HSCT
• For participants with CR, the end of initial treatment should be ≤ 3 months from the planned first dose in this study.
• Adequate bone marrow hematopoietic function and organ function reserve.
• LVEF ≥ 50% by ECHO.
• Should be able to follow the relevant requirements of this study for medication and follow-up.
• If there is a potential for conception for the female spouses (partners) of male participants, the spouses (partners) should take physical contraceptive measures (such as condoms) during the participant participating in the trial and within 6 months after the end of treatment.
• Male participants should also avoid sperm donation during the trial and within 6 months after the end of treatment.
• Female participants should take adequate contraceptive measures and vasoligation of the partner during the trial and within 3 months after the end of the trial. All hormonal contraceptive methods (except abstinence) should be used in conjunction with the use of a condom by the male partner. Breastfeeding is prohibited for female participants. Female participants of conception potential should have a negative pregnancy test prior to initiation of treatment.

You may not qualify if:

• With any of the following treatment history:
• The use of the investigational product or investigational product in another project within 30 days prior to the start of dosing in this study.
• The cytotoxic chemotherapeutic agents are not discontinued within 21 days prior to the start of dosing in this study.
• Prior use of histone deacetylase (HDAC) inhibitors (e.g., romidepsin, chidamide, belinostat) or pralatrexate within 1 week prior to the start of dosing in this study.
• Prior use of corticosteroid therapy at equivalent prednisone dose \> 15 mg/day within 1 week prior to the start of dosing in this study.
• Undergoing major surgery (excluding vascular access surgery) or serious trauma within 4 weeks prior to the start of dosing in this study; or anticipated to undergo potential surgery after the start of dosing in this study.
• Prior use of anti-tumor macromolecular antibody agents (including brentuximab vedotin) within 4 weeks; radiation therapy within 3 weeks; and other toxin/isotope-immune antibody couplers within 10 weeks prior to the start of dosing in this study.
• With prior use of JAK or STAT3 inhibitors.
• Prior use of anti-tumor immunotherapy (e.g., immune checkpoint inhibitors, including PD-1, PD-L1, and CTLA-4) within 28 days prior to the start of dosing in this study. For participants treated with other types of novel therapy, whether they can be included may be jointly decided by the investigator and the sponsor's study physician.
• Vaccination with attenuated vaccines or viral vector vaccines within 28 days prior to the start of dosing in this study.
• Currently on treatment with vitamin K antagonists, antiplatelets, and anticoagulants (or these drugs cannot be discontinued within 1 week prior to the start of dosing in this study).
• Currently on treatment with (or unable to discontinue the use within 1 week prior to the start of dosing in this study) certain known drugs, herbs, or supplements that may significantly induce or inhibit CYP3A or can serve as sensitive substrates of BCRP/P-gp, with low therapeutic indexes.
• With unresolved \> CTCAE Grade 1 adverse drug reactions (except alopecia) prior to the start of dosing in this study.
• Central nervous system or meninges involvement by the lymphoma.
• With significant lung function impairment (i.e., pulmonary function tests show FEV1 and DLCO \< 60% of predicted values). Participants with prior history of non-infectious pneumonitis, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy, or evidence showing clinically active interstitial lung disease.

Sponsors & Collaborators

• Dizal Pharmaceuticals: lead

Study Sites (23)

Anhui Provincial Hospital (The First Affiliated Hospital of USTC)

Hefei, Anhui, China

Location

Peking university Third Hospital

Beijing, Beijing Municipality, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Location

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, China

Location

Hainan General Hospital

Haikou, Hainan, China

Location

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, China

Location

Hubei Cancer Hospital

Wuhan, Hubei, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

Hunan Cancer Hospital

Changsha, Hunan, China

Location

Research Center of Clinical Trials, The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

Shandong Cancer Hospital & Institution

Jinan, Shandong, China

Location

Linyi Cancer Hospital

Linyi, Shandong, China

Location

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Location

Yunnan Cancer Hospital

Kunming, Yunnan, China

Location

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Jie Jin

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 22, 2024
• Study Start: March 17, 2022
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (23)