Phase 2 Leukaemia Trial, Recruiting NCT05475925 Sponsor: Dren Bio Condition: Leukaemia
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Phase 2 Leukaemia Trial, Recruiting

NCT05475925
Recruiting Phase 2 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are 18 years of age or older
  • People who are able to understand the study requirements and are willing to sign a consent form
  • People whose key organs (such as heart, liver, and kidneys) and blood clotting ability are functioning at a sufficient level
  • Women who could become pregnant must agree to use a highly effective form of contraception from the time of joining the trial until at least 12 months after their last dose of the study drug
  • Men must agree to use an effective form of contraception during the trial
  • People with a condition called LGLL must have already stopped at least one previous treatment for their condition, and must also meet additional disease-specific criteria set by the trial team (confirm with trial site)
  • People with certain types of lymphoma (called cytotoxic lymphomas) must have already tried and not responded to at least one previous treatment
  • People with cytotoxic lymphomas must have a tissue sample available from after their disease worsened, or be willing to have a biopsy taken at the start of the trial
  • People with cytotoxic lymphomas must have their diagnosis confirmed by a specialist blood cancer pathologist
  • Depending on which part of the trial a person is enrolled in, their disease may need to be detectable and measurable in specific ways on scans or blood tests (confirm with trial site)

Who may not be able to join:

  • People whose increased white blood cell count is caused by a viral infection, or is linked to certain other blood disorders (MDS or AML), rather than being a true diagnosis of LGLL or ANKL
  • People with a serious active infection (such as bacterial, viral, or fungal) that requires treatment through the bloodstream
  • People with cancer that has spread to, or is suspected to have spread to, the brain or spinal cord
  • People with life-threatening complications from their cancer, such as uncontrolled bleeding, severe pneumonia, or a serious blood clotting disorder
  • People with another active cancer diagnosis
  • People living with HIV (type 1 or 2)
  • People with active Hepatitis B, or active Hepatitis C with detectable virus (people who have been treated for Hepatitis C and have no detectable virus may still be considered)
  • People with a significant history of heart disease or heart failure beyond a mild level
  • People who have recently used steroid medications above certain dose levels, or other immune-suppressing drugs, within a set period before starting the trial
  • People who require ongoing hormonal treatment for a medical condition (not including contraception, hormone replacement therapy, or hormonal treatment to prevent a previous cancer returning)
  • People with any other medical or mental health condition, or abnormal test results, that the trial doctor believes would make participation unsafe
  • People who still have significant side effects from previous cancer treatments that have not returned to near-normal levels
  • People who have had a stem cell transplant using their own cells within 40 days, or a stem cell transplant using a donor's cells within 90 days, before starting the trial
  • People who are still receiving immune-suppressing treatment to manage complications from a donor stem cell transplant
  • People who have had major surgery within 28 days before starting the trial

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Wan-Jen Hong, MD, Dren Bio

Phone: 415-737-5277

Australian sites

Dren Investigational Site, Clayton, Victoria
415-737-5277
Dren Investigational Site, Richmond, Victoria
415-735-5277
Dren Investigational Site, Nedlands, Washington
415-735-5277

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Dren Bio
Registry
ClinicalTrials.gov
Start date
13 July 2022
Est. completion
1 December 2026

Where this trial is recruiting

🇦🇺 Australia 🇫🇷 France 🇩🇪 Germany Hong Kong 🇮🇹 Italy 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan 🇺🇸 United States

3 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Part A: Safety and Tolerability. To determine the incidence and severity of adverse events as assessed by CTCAE v5.0.; Part A: Safety and Tolerability. To determine the incidence and severity of dose limiting toxicities (DLTs) as defined by protocol specified DLT criteria.; Part A: To determine potential pharmacologically optimized dose/regimen for DR-01 in LGL leukemia and cytotoxic lymphoma populations as determined using an integrated assessment of efficacy, safety, PK/PD, and exposure-response relationships.; Part B: Overall Response Rate (ORR), defined as the proportion of subjects with C...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov