Phase 2 Leukaemia Trial, Recruiting
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.
Contact this trial
Principal Investigator: Wan-Jen Hong, MD, Dren Bio
Phone: 415-737-5277
Australian sites
415-737-5277
415-735-5277
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
Where this trial is recruiting
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?
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.