LGLL - Large Granular Lymphocytic LeukemiaPhase 1/2NCT05475925
A Study of DR-01 in Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas
A Phase 1/2 study testing DR-01 in people with LGLL - Large Granular Lymphocytic Leukemia and Primary Cutaneous Gamma-Delta T-Cell Lymphoma, run by Dren Bio at 37 sites in 9 countries.
Trial summary
This is a multicenter, first-in-human, Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of DR-01 in adult patients with large granular lymphocytic leukemia or cytotoxic lymphomas Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- LGLL - Large Granular Lymphocytic Leukemia, Primary Cutaneous Gamma-Delta T-Cell Lymphoma, Primary Cutaneous CD8+ Aggressive Epidermotropic T-Cell Lymphoma
- What is being tested?
- DR-01
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 37 sitesin 9 countries
- Study dates
- 13 Jul 2022to Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 of age.
- Able to understand and comply with protocol-required study procedures and voluntarily sign a written informed consent document.
- Sufficient key organ performance and coagulation.
- Female subjects of childbearing potential (postmenarcheal, has an intact uterus and at least one ovary, and is <1 year postmenopausal) must agree to use a highly effective method of contraception from enrollment through at least 12 months after last dose of DR-01.
- Male subjects must agree to use acceptable effective method(s) of contraception.
- Subjects with LGLL must also meet inclusion criteria 6 and 7.
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- Must have discontinued at least one prior line of systemic therapy.
- Additional immunophenotypic and symptomatic criteria must be met.
- Disease-specific Inclusion Criteria (Cytotoxic Lymphomas):
- Subjects with cytotoxic lymphomas must also meet inclusion criteria 8,9, and 10.
- Subjects must have failed at least one prior systemic regimens.
- Availability of post-progression tissue sample or willingness to consent to a baseline biopsy.
- Histologically confirmed diagnosis of a cytotoxic lymphoma by a hematopathologist (according to the WHO 2016 classification [Swerdlow 2016]).
- For Part A only, evaluable disease is acceptable.
- For Part B2 only, evaluable by the following response criteria as documented during Screening:
- For cytotoxic PTCL-NOS, ENKTL, MEITL, EATL, SPTCL - Subjects must have radiographically measurable disease by computed tomography (CT) or CT/positron emission tomography (PET) scan defined as at least one node measuring >1.5 cm or measurable extranodal lesion of at least 1.0 cm in longest diameter to be evaluated by Lugano criteria (Cheson 2014).
- For PCGDTCL, ET-CTCL, HVLPD, cytotoxic CuPTCL-NOS - Subjects with primary cutaneous variants must have at least 1 measurable lesion that is evaluable using the Olsen criteria (Olsen 2021) or have leukemic involvement that can be evaluated using modified TPLL response criteria (Staber 2019).
- For HSTCL, ANKL, SysEBV TCL - Subjects with hepatosplenic disease without measurable disease by Lugano criteria (Cheson 2014) or leukemic involvement in BM or peripheral blood that is evaluable for response using a modified TPLL response criteria (Staber 2019).
Who cannot join
- Disease-specific Exclusion Criteria; LGLL and ANKL:
- A reactive LGL lymphocytosis to a viral infection or LGL associated with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
- The following exclusion criteria apply to all subjects:
- Active systemic infection or severe localized infection requiring systemic antibiotics, antivirals or antifungals.
- Active or suspected malignant central nervous system involvement.
- Life-threatening, severe complications of malignancy (e.g., uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation).
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- Active known second malignancy.
- Infection with human immunodeficiency virus (HIV) type 1 or 2 (HIV-1 or HIV-2).
- Hepatitis B infection (hepatitis B virus surface antigen [HBsAg] positive), or hepatitis C (hepatitis C virus [HCV] antibody positive, confirmed by HCV ribonucleic acid). Subjects with HCV with undetectable virus after treatment are eligible.
- History of clinically significant cardiac disease or congestive heart failure greater than New York Heart Association (NYHA) Class II.
- Use of systemic corticosteroids at prohibited dose levels within 15 days prior to C1D1 (except for prophylaxis for radiodiagnostic contrast reactions and study-defined premedication) or use of other non-biological immunosuppressive drugs within 15 days or 5 half-lives (whichever is less) prior to C1D1.
- Any condition requiring hormonal therapy (except for contraception, hormone replacement therapy and hormonal prophylaxis for a prior malignancy).
- Any other medical or psychiatric condition, or laboratory abnormality that would increase the risk associated with study participation, in the opinion of the Investigator or Medical Monitor.
- Toxicities from previous anticancer therapies must have resolved to baseline levels or to Grade 1 (except for alopecia, peripheral neuropathy, or hematologic parameters meeting inclusion criteria).
- Autologous HSCT within 40 days of C1D1, allogeneic HSCT within 90 days
- Any immunosuppressive therapy for GVHD for subjects who are post allogeneic HSCT.
- Major surgery within 28 days of C1D1 (requires more than local anesthesia or plexus blockade).
Trial locations and contacts
37 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
37 sites in 9 countries
United States15 sites, 15 recruiting
- Recruiting
Dren Investigational Site
Birmingham, Alabama, 35233
Dren Central Contact, 415-735-5277, DR-01-ONC-001_inquiries@drenbio.com
- Recruiting
Dren Investigational Site
Boston, Massachusetts, 02114
Dren Central Contact, 415-735-5277, DR-01-ONC-001_inquiries@drenbio.com
- Recruiting
Dren Investigational Site
Charlottesville, Virginia, 22903
Dren Central Contact, 415-735-5277, DR-01-ONC-001_inquiries@drenbio.com
- Recruiting
Dren Investigational Site
Columbus, Ohio, 43210
Dren Central Contact, 415-735-5277, DR-01-ONC-001_inquiries@drenbio.com
- Recruiting
Dren Investigational Site
Duarte, California, 91010
Dren Central Contact, 415-737-5277, DR-01-ONC-001_inquiries@drenbio.com
- Recruiting
Dren Investigational Site
Fairfax, Virginia, 22031
Dren Central Contact, 415-737-5277, DR-01-ONC-001_inquiries@drenbio.com
- Recruiting
Dren Investigational Site
Houston, Texas, 77030
Dren Central Contact, 415-737-5277, DR-01-ONC-001_inquiries@drenbio.com
- Recruiting
Dren Investigational Site
Irvine, California, 92612
Dren Central Contact, 415-737-5277, DR-01-ONC-001_inquiries@drenbio.com
- Recruiting
Dren Investigational Site
New Haven, Connecticut, 06519
Dren Central Contact, 415-737-5277, DR-01-ONC-001_inquiries@drenbio.com
- Recruiting
Dren Investigational Site 1
New York, New York, 10021
Dren Central Contact, 415-735-5277, DR-01-ONC-001_inquiries@drenbio.com
- Not yet recruiting
Dren Investigational Site 2
New York, New York, 10032
Dren Central Contact, 415-737-5277, DR-01-ONC-001_inquiries@drenbio.com
- Recruiting
Dren Investigational Site 2
Pittsburgh, Pennsylvania, 15213
Dren Central Contact, 415-737-5277, DR-01-ONC-001_inquiries@drenbio.com
- Recruiting
Dren Investigational Site
Redwood City, California, 94063
Dren Central Contact, 415-735-5277, DR-01-ONC-001_inquiries@drenbio.com
- Recruiting
Dren Investigational Site
Seattle, Washington, 98109
Dren Cntral Contact, 415-737-5277, DR-01-ONC-001_inquiries@drenbio.com
- Recruiting
Dren Investigational Site
Tampa, Florida, 33612
Dren Central Contact, 415-737-5277, DR-01-ONC-001_inquiries@drenbio.com
South Korea6 sites, 6 recruiting
- Recruiting
Dren Investigational Site 1
Busan
Dren Central Contact, 415-737-5277, DR-01-ONC-001_inquiries@drenbio.com
- Recruiting
Dren Investigational Site 2
Busan
Dren Central Contact, 415-737-5277, DR-01-ONC-001_inquiries@drenbio.com
- Recruiting
Dren Investigational Site
Goyang-si
Dren Central Contact, 415-737-5277, DR-01-ONC-001_inquiries@drenbio.com
- Recruiting
Dren Investigational Site 1
Seoul
Dren Central Contact, 415-737-5277, DR-01-ONC-001_inquiries@drenbio.com
- Recruiting
Dren Investigational Site 2
Seoul
Dren Central Contact, 415-737-5277, DR-01-ONC-001_inquiries@drenbio.com
- Recruiting
Dren Investigational Site 3
Seoul
Dren Central Contact, 415-737-5277, DR-01-ONC-001_inquiries@drenbio.com
Australia3 sites, 3 recruiting
- Recruiting
Dren Investigational Site
Clayton, Victoria, 3168
Dren Central Contact, 415-737-5277, DR-01-ONC-001_inquiries@drenbio.com
- Recruiting
Dren Investigational Site
Nedlands, Washington, 6009
Dren Central Contact, 415-735-5277, DR-01-ONC-001_inquiries@drenbio.com
- Recruiting
Dren Investigational Site
Richmond, Victoria, 3121
Dren Central Contact, 415-735-5277, DR-01-ONC-001_inquiries@drenbio.com
France3 sites, 3 recruiting
- Recruiting
Dren Investigational Site
Pierre-Bénite, 69310
Dren Central Contact, 415-737-5277, DR-01-ONC-001_inquiries@drenbio.com
- Recruiting
Dren Investigational Site
Rennes, 35000
Dren Central Contact, 415-737-5277, DR-01-ONC-001_inquiries@drenbio.com
- Recruiting
Dren Investigational Site
Toulouse, 31059
Dren Central Contact, 415-737-5277, DR-01-ONC-001_inquiries@drenbio.com
Germany3 sites, 3 recruiting
- Recruiting
Dren Investigational Site
Berlin, 10117
Dren Central Contact, 415-737-5277, DR-01-ONC-001_inquiries@drenbio.com
- Recruiting
Dren Investigational Site
Cologne, 50937
Dren Central Contact, 415-737-5277, DR-01-ONC-001_inquiries@drenbio.com
- Recruiting
Dren Investigational Site
Leipzig, 04103
Dren Central Contact, 415-737-5277, DR-01-ONC-001_inquiries@drenbio.com
Hong Kong2 sites, 2 recruiting
- Recruiting
Dren Investigational Site 1
Hong Kong, Hong Kong
Dren Central Contact, 415-737-5277, DR-01-ONC-001_inquiries@drenbio.com
- Recruiting
Dren Investigational Site 2
Hong Kong
Dren Central Contact, 415-737-5277, DR-01-ONC-001_inquiries@drenbio.com
Spain2 sites, 2 recruiting
- Recruiting
Dren Investigational Site
Barcelona, 08035
Dren Central Contact, 415-737-5277, DR-01-ONC-001_inquiries@drenbio.com
- Recruiting
Dren Investigational Site
Salamanca, 37007
Dren Central Contact, 415-737-5277, DR-01-ONC-001_inquiries@drenbio.com
Taiwan2 sites, 2 recruiting
- Recruiting
Dren Investigational Site
Tainan
Dren Central Contact, 415-737-5277, DR-01-ONC-001_inquiries@drenbio.com
- Recruiting
Dren Investigational Site
Taipei
Dren Central Contact, 415-737-5277, DR-01-ONC-001_inquiries@drenbio.com
Italy1 site, 1 recruiting
- Recruiting
Dren Investigational Site
Bologna, 40126
Dren Central Contact, 415-737-5277, DR-01-ONC-001_inquiries@drenbio.com
About this study
Official title: A Multicenter, Open-Label, First-In-Human, Multiple Expansion Cohort, Phase 1/2 Study to Evaluate the Safety and Efficacy of DR-01 in Adult Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas
This is a multicenter, first-in-human, Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of DR-01 in adult patients with large granular lymphocytic leukemia or cytotoxic lymphomas
- Conditions
- LGLL - Large Granular Lymphocytic Leukemia, Primary Cutaneous Gamma-Delta T-Cell Lymphoma, Primary Cutaneous CD8+ Aggressive Epidermotropic T-Cell Lymphoma, Hepatosplenic T-cell Lymphoma, Subcutaneous Panniculitis-Like T-Cell Lymphoma, Aggressive NK Cell Leukemia
- Being tested
- DR-01
- Keywords
- LGLL, Cytotoxic, Lymphoma, ANKL, EATL, MEITL, ENKL, HSTCL, Leukemia, SPTCL, ENKTL, CTCL, PTCL-NOS, TCL
- Medical subject headings
- Leukemia, Large Granular Lymphocytic, Subcutaneous panniculitis-like T-cell lymphoma, Lymphoma, Extranodal NK-T-Cell, Enteropathy-Associated T-Cell Lymphoma, Lymphoma, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DR-01Drug
DR-01 is a non-fucosylated, human immunoglobulin G1 (IgG1) monoclonal antibody.
| Study group | Role | What they receive |
|---|---|---|
| Part A Dose Escalation 1 mg/kg of DR-01 | Experimental | Subjects in this arm will initially receive 1 mg/kg at either the Primary regimen (bi-weekly dosing for fist month), Secondary regimen (doses at Days 1, 8, 15, 29 during first month), or Tertiary regimen (dosing days 1-5, 15, 29 during first month), followed by monthly dosing (up to 6 mg/kg) thereafter for up to 25 cycles total. Receives: Drug: DR-01 |
| Part A Dose Escalation 3 mg/kg of DR-01 | Experimental | Subjects in this arm will initially receive 3 mg/kg at either the Primary regimen (bi-weekly dosing for fist month), Secondary regimen (doses at Days 1, 8, 15, 29 during first month), or Tertiary regimen (dosing days 1-5, 15, 29 during first month), followed by monthly dosing (up to 10 mg/kg) thereafter for up to 25 cycles total. Receives: Drug: DR-01 |
| Part A Dose Escalation 6 mg/kg of DR-01 | Experimental | Subjects in this arm will initially receive 6 mg/kg at either the Primary regimen (bi-weekly dosing for fist month), Secondary regimen (doses at Days 1, 8, 15, 29 during first month), or Tertiary regimen (dosing days 1-5, 15, 29 during first month), followed by monthly dosing (up to 10 mg/kg) thereafter for up to 25 cycles total. Receives: Drug: DR-01 |
| Part A Dose Escalation 10 mg/kg of DR-01 | Experimental | Subjects in this arm will initially receive 10 mg/kg at either the Primary regimen (bi-weekly dosing for fist month), Secondary regimen (doses at Days 1, 8, 15, 29 during first month), or Tertiary regimen (dosing days 1-5, 15, 29 during first month), followed by monthly dosing (up to 10 mg/kg) thereafter for up to 25 cycles total. Receives: Drug: DR-01 |
| Part A Dose De-escalation 0.3 to <1 mg/kg of DR-01 | Experimental | This cohort would only be triggered should a DLT occur at Dose Level 1 or if recommended by the Safety Review Committee. Subjects in this arm would initially receive 0.3 to <1 mg/kg at either the Primary regimen (bi-weekly dosing for fist month), Secondary regimen (doses at Days 1, 8, 15, 29 during first month), or Tertiary regimen (dosing days 1-5, 15, 29 during first month), followed by monthly dosing (up to 3 mg/kg) thereafter for up to 25 cycles total. Receives: Drug: DR-01 |
| Part B Dose Expansion (Cohort B1) Optimized Dose/Regimen of DR-01 | Experimental | Subjects in this arm will receive the pharmacologically optimized dose/regimen for LGL leukemia subjects determined in Part A. Depending on the selected dose/regimen, subjects will receive target dose at either the Primary regimen (bi-weekly dosing for fist month), Secondary regimen (doses at Days 1, 8, 15, 29 during first month), or Tertiary regimen (dosing days 1-5, 15, 29 during first month), followed by monthly dosing thereafter for up to 25 doses total. Receives: Drug: DR-01 |
| Part B Dose Expansion (Cohort B2) Optimized Dose/Regimen of DR-01 | Experimental | Subjects in this arm will receive the pharmacologically optimized dose/regimen for cytotoxic lymphoma subjects determined in Part A. Depending on the selected dose/regimen, subjects will receive target dose at either the Primary regimen (bi-weekly dosing for fist month), Secondary regimen (doses at Days 1, 8, 15, 29 during first month), or Tertiary regimen (dosing days 1-5, 15, 29 during first month), followed by monthly dosing thereafter for up to 25 doses total. Receives: Drug: DR-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Safety and Tolerability. To determine the incidence and severity of adverse events as assessed by CTCAE v5.0.
Measured: Up to 25 months
Part A: Safety and Tolerability. To determine the incidence and severity of dose limiting toxicities (DLTs) as defined by protocol specified DLT criteria.
Measured: During First 28 days (Cycle 1)
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.
Measured: Up to 6 months
Part B: Overall Response Rate (ORR), defined as the proportion of subjects with Complete Response (CR) or Partial Response (PR) based on disease-specific response criteria.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start13 Jul 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LGLL - Large Granular Lymphocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dren Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wan-Jen Hong, MD, Study director, Dren Bio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475925
- Sponsor's protocol ID
- DR-01-ONC-001
- Status last verified
- Jun 2026
- First submitted
- 21 Jul 2022
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, First-In-Human, Multiple Expansion Cohort, Phase 1/2 Study to Evaluate the Safety and Efficacy of DR-01 in Adult Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas
- ClinicalTrials.gov ID
- NCT05475925
- Acronym / sponsor ID
- DR-01-ONC-001
- Conditions
- LGLL - Large Granular Lymphocytic Leukemia, Primary Cutaneous Gamma-Delta T-Cell Lymphoma, Primary Cutaneous CD8+ Aggressive Epidermotropic T-Cell Lymphoma, Hepatosplenic T-cell Lymphoma, Subcutaneous Panniculitis-Like T-Cell Lymphoma, Aggressive NK Cell Leukemia
- Keywords
- LGLL, Cytotoxic, Lymphoma, ANKL, EATL, MEITL, ENKL, HSTCL
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Dren BioIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, first-in-human, Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of DR-01 in adult patients with large granular lymphocytic leukemia or cytotoxic lymphomas
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part A Dose Escalation 1 mg/kg of DR-01 | Experimental | Drug: DR-01Subjects in this arm will initially receive 1 mg/kg at either the Primary regimen (bi-weekly dosing for fist month), Secondary regimen (doses at Days 1, 8, 15, 29 during first month), or Tertiary regimen (dosing days 1-5, 15, 29 during first month), followed by monthly dosing (up to 6 mg/kg) thereafter for up to 25 cycles total. |
| Part A Dose Escalation 3 mg/kg of DR-01 | Experimental | Drug: DR-01Subjects in this arm will initially receive 3 mg/kg at either the Primary regimen (bi-weekly dosing for fist month), Secondary regimen (doses at Days 1, 8, 15, 29 during first month), or Tertiary regimen (dosing days 1-5, 15, 29 during first month), followed by monthly dosing (up to 10 mg/kg) thereafter for up to 25 cycles total. |
| Part A Dose Escalation 6 mg/kg of DR-01 | Experimental | Drug: DR-01Subjects in this arm will initially receive 6 mg/kg at either the Primary regimen (bi-weekly dosing for fist month), Secondary regimen (doses at Days 1, 8, 15, 29 during first month), or Tertiary regimen (dosing days 1-5, 15, 29 during first month), followed by monthly dosing (up to 10 mg/kg) thereafter for up to 25 cycles total. |
| Part A Dose Escalation 10 mg/kg of DR-01 | Experimental | Drug: DR-01Subjects in this arm will initially receive 10 mg/kg at either the Primary regimen (bi-weekly dosing for fist month), Secondary regimen (doses at Days 1, 8, 15, 29 during first month), or Tertiary regimen (dosing days 1-5, 15, 29 during first month), followed by monthly dosing (up to 10 mg/kg) thereafter for up to 25 cycles total. |
| Part A Dose De-escalation 0.3 to <1 mg/kg of DR-01 | Experimental | Drug: DR-01This cohort would only be triggered should a DLT occur at Dose Level 1 or if recommended by the Safety Review Committee. Subjects in this arm would initially receive 0.3 to <1 mg/kg at either the Primary regimen (bi-weekly dosing for fist month), Secondary regimen (doses at Days 1, 8, 15, 29 during first month), or Tertiary regimen (dosing days 1-5, 15, 29 during first month), followed by monthly dosing (up to 3 mg/kg) thereafter for up to 25 cycles total. |
| Part B Dose Expansion (Cohort B1) Optimized Dose/Regimen of DR-01 | Experimental | Drug: DR-01Subjects in this arm will receive the pharmacologically optimized dose/regimen for LGL leukemia subjects determined in Part A. Depending on the selected dose/regimen, subjects will receive target dose at either the Primary regimen (bi-weekly dosing for fist month), Secondary regimen (doses at Days 1, 8, 15, 29 during first month), or Tertiary regimen (dosing days 1-5, 15, 29 during first month), followed by monthly dosing thereafter for up to 25 doses total. |
| Part B Dose Expansion (Cohort B2) Optimized Dose/Regimen of DR-01 | Experimental | Drug: DR-01Subjects in this arm will receive the pharmacologically optimized dose/regimen for cytotoxic lymphoma subjects determined in Part A. Depending on the selected dose/regimen, subjects will receive target dose at either the Primary regimen (bi-weekly dosing for fist month), Secondary regimen (doses at Days 1, 8, 15, 29 during first month), or Tertiary regimen (dosing days 1-5, 15, 29 during first month), followed by monthly dosing thereafter for up to 25 doses total. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- ≥18 years of age.
- Able to understand and comply with protocol-required study procedures and voluntarily sign a written informed consent document.
- Sufficient key organ performance and coagulation.
- Female subjects of childbearing potential (postmenarcheal, has an intact uterus and at least one ovary, and is <1 year postmenopausal) must agree to use a highly effective method of contraception from enrollment through at least 12 months after last dose of DR-01.
- Male subjects must agree to use acceptable effective method(s) of contraception.
Key exclusion criteria (17 listed)
- A reactive LGL lymphocytosis to a viral infection or LGL associated with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
- Active systemic infection or severe localized infection requiring systemic antibiotics, antivirals or antifungals.
- Active or suspected malignant central nervous system involvement.
- Life-threatening, severe complications of malignancy (e.g., uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation).
- Active known second malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DR-01DR-01 is a non-fucosylated, human immunoglobulin G1 (IgG1) monoclonal antibody. | Drug | Part A Dose De-escalation 0.3 to <1 mg/kg of DR-01, Part A Dose Escalation 1 mg/kg of DR-01, Part A Dose Escalation 10 mg/kg of DR-01, Part A Dose Escalation 3 mg/kg of DR-01, Part A Dose Escalation 6 mg/kg of DR-01, Part B Dose Expansion (Cohort B1) Optimized Dose/Regimen of DR-01, Part B Dose Expansion (Cohort B2) Optimized Dose/Regimen of DR-01 |
Primary outcome
Part A: Safety and Tolerability. To determine the incidence and severity of adverse events as assessed by CTCAE v5.0.
Time frame: Up to 25 months
Part A: Safety and Tolerability. To determine the incidence and severity of dose limiting toxicities (DLTs) as defined by protocol specified DLT criteria.
Time frame: During First 28 days (Cycle 1)
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.
Time frame: Up to 6 months
Part B: Overall Response Rate (ORR), defined as the proportion of subjects with Complete Response (CR) or Partial Response (PR) based on disease-specific response criteria.
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wan-Jen Hong, MD study director
Dren Bio
37 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DR-01 in people with LGLL - Large Granular Lymphocytic Leukemia and Primary Cutaneous Gamma-Delta T-Cell Lymphoma, run by Dren Bio at 37 sites in 9 countries.
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 18 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, South Korea, Australia, France, Germany and 4 more countries. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dren Central Contact (415-737-5277, DR-01-ONC-001_inquiries@drenbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: Safety and Tolerability. To determine the incidence and severity of adverse events as assessed by CTCAE v5.0. (time frame: Up to 25 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2026.