AzTrials
AzTrials

Peripheral T Cell LymphomaPhase 2NCT06511895

AZD4205 in Relapsed or Refractory Peripheral T Cell Lymphoma (JACKPOT27)

A Phase 2 study testing AZD4205 in people with Peripheral T Cell Lymphoma, run by Dizal Pharmaceuticals at 19 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a phase II, open label, multicenter study of AZD4205 administered orally in participants with r/r PTCL to determine its safety, tolerability, PK, and anti-tumor activity. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral T Cell Lymphoma
What is being tested?
AZD4205
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
19 sitesChina
Study dates
31 May 2022to 17 Oct 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 18 years old (for Korean ≥ 19 years old)
  • ECOG performance status 0-2 with no deterioration over the previous 2 weeks
  • Predicted life expectancy ≥ 12 weeks.
  • Histologically confirmed PTCL by local pathology review according to the 2016 revision of the WHO classification of lymphoid neoplasms. Eligible histological subtypes are restricted to the following:
  • PTCL-NOS
  • AITL
Show all 19Show fewer
  • ALCL ALK+
  • ALCL ALK-
  • EATL
  • MEITL
  • NKTCL
  • HSTCL
  • SPTCL
  • Have measurable disease according to the 2014 Lugano classification
  • Must have progressed on or are refractory to standard systemic therapy, or patients were intolerant to standard systemic therapy. Participants should be transplant-ineligible upon their entries to this study.
  • Adequate bone marrow reserve and organ system functions
  • LVEF ≥ 55% assessed by ECHO or MUGA.
  • Male participant with female partners of child-bearing potential should be willing to use barrier contraceptives (i.e., by use of condoms), during his participation in this study and for 6 months following the last dose of the study drug. Male participant must refrain from donating sperm during their participation in the study and at least for 6 months after the last treatment.
  • Female participant should be using adequate contraceptive measures while on study drug and for 3 months following the last dose of study drug.

Who cannot join

  • Intervention with any of the following:
  • Any investigational agents or study drugs from a previous clinical study within 30 days of the first dose of study treatment.
  • Any cytotoxic chemotherapy from a previous treatment regimen within 21 days of the first dose of study treatment.
  • Prior HDAC inhibitors (including romidepsin, belinostat and chidamide) or pralatrexate therapy within one week of the start of the study treatment.
  • Corticosteroids at dosages equivalent to prednisone > 15 mg/day within 7 days of the start of the study treatment.
  • Major surgery procedure (excluding placement of vascular access), or significant traumatic injury within 4 weeks of the first dose of study treatment, or have an anticipated need for major surgery during the study.
Show all 34Show fewer
  • Prior therapeutic anticancer antibodies (including brentuximab vedotin) within 4 weeks, other radio- or toxin-immunoconjugates within 10 weeks, radiation therapy within 3 weeks.
  • Has undergone an allogeneic stem cell transplant. Participant had autologous stem cell transplant within 6 months.
  • Prior treatment with a JAK or STAT3 inhibitor.
  • Prior treatment with any onco-immunotherapy in 28 days prior to first dosing of AZD4205.
  • Live vaccines within 28 days prior to first dose.
  • Currently receiving (or unable to stop use at least 1 week prior to receiving the first dose) vitamin K antagonists, anti-platelet agents or anticoagulated agents.
  • Currently receiving (or unable to stop use at least 1 week prior to receiving the first dose) medications or herbal supplements known to be potent inhibitors or inducers of CYP3A or sensitive substrates of BCRP or P-gp with narrow therapeutic index.
  • Any unresolved toxicities from prior therapy, greater than CTCAE v 5.0 Grade 1 at the time of starting study treatment with the exception of alopecia.
  • Central nervous system or leptomeningeal lymphoma.
  • With severely decreased lung function (i.e. any parameter of FEV1, and DLCO < 60% of predicted value). Past medical history of pneumonitis, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
  • With disease condition which requires the treatment of immunosuppressants, biologics, or NSAIDs (non-steroid anti-inflammatory drugs).
  • Active infections including:
  • History of known latent or active tuberculosis (TB).
  • Known infection with HIV, or serologic status reflecting active hepatitis B or hepatitis C infection.
  • Active viral infections (i.e. zoster) other than hepatitis B or C.
  • Infections requiring oral or intravenous antimicrobial therapy or interferon.
  • Bacterial infections including pneumonia within 30 days.
  • Any of the following cardiac criteria:
  • Congestive heart failure (CHF) per NYHA classification > Class II.
  • Clinically significant valvular diseases, hypertrophic or constrictive cardiomyopathy.
  • Any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG, e.g., complete left bundle branch block, third degree heart block, and second-degree heart block, PR interval > 250 msec.
  • Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
  • AMI within 6 months prior to starting treatment, unstable angina or new-onset angina.
  • With heart transplant.
  • Mean resting corrected QTcF interval (QTC) > 450 ms on ECG.
  • With factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalaemia, congenital long QT syndrome, any concomitant medication known to prolong the QT interval) or family history of long QT interval syndrome or unexplained sudden death under 40 years of age in first degree relatives.
  • With previous/current thrombotic diseases such as pulmonary embolism, and deep venous thrombosis.
  • Another malignancy within 5 years prior to enrollment with the exception of adequately treated in-situ carcinoma of the cervix, uterus, basal or squamous cell carcinoma or non-melanomatous skin cancer.

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

China19 sites

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality

  • Peking University Third Hospital

    Beijing, Beijing Municipality

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin

  • Hunan Cancer Hospital

    Changsha, Hunan

  • West China Hospital of Sichuan University

    Chengdu, Sichuan

  • Chongqing Cancer Hospital

    Chongqing, Chongqing Municipality

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong

  • Hainan General Hospital

    Haikou, Hainan

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

  • Anhui Provincial Hospital (The First Affiliated Hospital of USTC)

    Hefei, Anhui

  • The Second Hospital of Anhui Meidcine University

    Hefei, Anhui

  • Shandong Cancer Hospital & Insititution

    Jinan, Shandong

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu

  • Ruijing Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei

  • Henan Cancer Hospital

    Zhengzhou, Henan

Other trials in China

About this study

Official title: A Phase II, Open-Label, Single-Arm Study to Investigate the Safety, Tolerability, and Anti-tumor Activity of AZD4205 Treating Relapsed or Refractory Peripheral T Cell Lymphoma (r/r PTCL)

This is a phase II, open label, multicenter study of AZD4205 administered orally in participants with r/r PTCL to determine its safety, tolerability, PK, and anti-tumor activity. Eligible participants are those who had pathologically confirmed PTCL and have relapsed after or been refractory/intolerant to at least one prior systemic treatment regimen. The primary objective of this study is to evaluate anti-tumor efficacy of AZD4205 at 150 mg once daily (RP2D) in participants with r/r PTCL. The safety, tolerability, and PK of AZD4205 in r/r PTCL at RP2D will also be investigated.

Being tested
AZD4205
Medical subject headings
Lymphoma, T-Cell, Peripheral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AZD4205Drug

    AZD4205 capsules administered at 150 mg or 75 mg orally, once daily, in 28-day cycle.

Study groups in NCT06511895
Study groupRoleWhat they receive
AZD4205 treatmentExperimentalCohort 1: Newly enrolled participants with r/r PTCL who were never exposed to AZD4205 (receive 150 mg or 75 mg). Cohort 2: Participants from other completed AZD4205 study if they are still benefiting from AZD4205 (receive 150 mg).
Receives: Drug: AZD4205

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR) assessed by investigators per Lugano criteria

    To assess the anti-tumor efficacy of AZD4205 as a single agent in r/r PTCL.

    Measured: Up to 2 years

Secondary outcomes (5)

  1. Duration of Response (DoR)

    To further assess the anti-tumor efficacy of AZD4205 as a single agent in r/r PTCL using other efficacy endpoints.

    Measured: Up to 2 years

  2. Time to Response (TTR)

    To further assess the anti-tumor efficacy of AZD4205 as a single agent in r/r PTCL using other efficacy endpoints.

    Measured: Up to 2 years

  3. Progression-free Survival (PFS)

    To further assess the anti-tumor efficacy of AZD4205 as a single agent in r/r PTCL using other efficacy endpoints.

    Measured: Up to 2 years

  4. Adverse events graded by CTCAE version 5.0

    To further assess the safety and tolerability of AZD4205 as a single agent in r/r PTCL.

    Measured: Up to 2 years

  5. Plasma concentration of AZD4205

    To characterize the pharmacokinetic of AZD4205 in plasma.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2024
  2. Study start31 May 2022
  3. Primary completion17 Oct 2025
  4. Study completion17 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06511895
Sponsor's protocol ID
DZ2021J0006
Status last verified
Dec 2025
First submitted
15 Jul 2024
Last updated
24 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD4205 in people with Peripheral T Cell Lymphoma, run by Dizal Pharmaceuticals at 19 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) assessed by investigators per Lugano criteria (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06511895.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in