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New hope for rare blood cancers: first human trial launches

NCT ID NCT05475925

Disease control Sponsor: Dren Bio Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called DR-01 in adults with rare types of leukemia or lymphoma. The goal is to see if it is safe and can shrink tumors. About 200 people will take part in this early-stage trial.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria (All Subjects): 1. ≥18 years of age. 2. Able to understand and comply with protocol-required study procedures and voluntarily sign a written informed consent document. 3. Sufficient key organ performance and coagulation. 4. 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. 5. Male subjects must agree to use acceptable effective method(s) of contraception. Subjects with LGLL must also meet inclusion criteria 6 and 7. 6. Must have discontinued at least one prior line of systemic therapy. 7. 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. 8. Subjects must have failed at least one prior systemic regimens. 9. Availability of post-progression tissue sample or willingness to consent to a baseline biopsy. 10. Histologically confirmed diagnosis of a cytotoxic lymphoma by a hematopathologist (according to the WHO 2016 classification \[Swerdlow 2016\]). 11. For Part A only, evaluable disease is acceptable. 12. For Part B2 only, evaluable by the following response criteria as documented during Screening: 1. 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). 2. 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). 3. 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). Exclusion Criteria: Disease-specific Exclusion Criteria; LGLL and ANKL: 1. 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: 2. Active systemic infection or severe localized infection requiring systemic antibiotics, antivirals or antifungals. 3. Active or suspected malignant central nervous system involvement. 4. Life-threatening, severe complications of malignancy (e.g., uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation). 5. Active known second malignancy. 6. Infection with human immunodeficiency virus (HIV) type 1 or 2 (HIV-1 or HIV-2). 7. 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. 8. History of clinically significant cardiac disease or congestive heart failure greater than New York Heart Association (NYHA) Class II. 9. 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. 10. Any condition requiring hormonal therapy (except for contraception, hormone replacement therapy and hormonal prophylaxis for a prior malignancy). 11. 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. 12. 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). 13. Autologous HSCT within 40 days of C1D1, allogeneic HSCT within 90 days 14. Any immunosuppressive therapy for GVHD for subjects who are post allogeneic HSCT. 15. Major surgery within 28 days of C1D1 (requires more than local anesthesia or plexus blockade).

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Conditions

The condition(s) this trial relates to.

aggressive NK-cell leukemia enteropathy-associated T-cell lymphoma extranodal nasal NK/T cell lymphoma hepatosplenic T-cell lymphoma hydroa vacciniforme-like lymphoma leukemia Leukemia, Large Granular Lymphocytic lymphoma Lymphoma, Extranodal NK-T-Cell monomorphic epitheliotropic intestinal T-cell lymphoma primary cutaneous aggressive epidermotropic CD8+ T-cell lymphoma primary cutaneous gamma-delta t-cell lymphoma subcutaneous panniculitis-like T-cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aggressive NK-cell leukemia Cutaneous PTCL-nos (CD8+ or CD56+ and cytotoxic marker) Cytotoxic PTCL-nos (CD8+ or CD56+ and cytotoxic marker) Enteropathy-associated T-cell lymphoma Extranodal NK/T cell lymphoma, nasal type Hepatosplenic T-cell lymphoma Hydroa vacciniforme-like lymphoproliferative disorder LGLL - large granular lymphocytic leukemia Monomorphic epitheliotropic intestinal T-cell lymphoma Primary cutaneous CD8+ aggressive epidermotropic T-cell lymphoma Primary cutaneous gamma-delta T-cell lymphoma Subcutaneous panniculitis-like T-cell lymphoma Systemic EBV1 T-cell lymphoma, if CD8 positive

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    37 sites in 9 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Dren Investigational Site

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • Dren Investigational Site

    RECRUITING

    Duarte, California, 91010, United States

  • Dren Investigational Site

    RECRUITING

    Irvine, California, 92612, United States

  • Dren Investigational Site

    RECRUITING

    Redwood City, California, 94063, United States

  • Dren Investigational Site

    RECRUITING

    New Haven, Connecticut, 06519, United States

  • Dren Investigational Site

    RECRUITING

    Tampa, Florida, 33612, United States

  • Dren Investigational Site

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Dren Investigational Site

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Dren Investigational Site

    RECRUITING

    Houston, Texas, 77030, United States

  • Dren Investigational Site

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • Dren Investigational Site

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Dren Investigational Site

    RECRUITING

    Seattle, Washington, 98109, United States

  • Dren Investigational Site

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • Dren Investigational Site

    RECRUITING

    Richmond, Victoria, 3121, Australia

  • Dren Investigational Site

    RECRUITING

    Nedlands, Washington, 6009, Australia

  • Dren Investigational Site

    RECRUITING

    Pierre-Bénite, 69310, France

  • Dren Investigational Site

    RECRUITING

    Rennes, 35000, France

  • Dren Investigational Site

    RECRUITING

    Toulouse, 31059, France

  • Dren Investigational Site

    RECRUITING

    Berlin, 10117, Germany

  • Dren Investigational Site

    RECRUITING

    Cologne, 50937, Germany

  • Dren Investigational Site

    RECRUITING

    Leipzig, 04103, Germany

  • Dren Investigational Site

    RECRUITING

    Bologna, 40126, Italy

  • Dren Investigational Site

    RECRUITING

    Goyang-si, South Korea

  • Dren Investigational Site

    RECRUITING

    Barcelona, 08035, Spain

  • Dren Investigational Site

    RECRUITING

    Salamanca, 37007, Spain

  • Dren Investigational Site

    RECRUITING

    Tainan, Taiwan

  • Dren Investigational Site

    RECRUITING

    Taipei, Taiwan

  • Dren Investigational Site 1

    RECRUITING

    New York, New York, 10021, United States

  • Dren Investigational Site 1

    RECRUITING

    Hong Kong, Hong Kong, Hong Kong

  • Dren Investigational Site 1

    RECRUITING

    Busan, South Korea

  • Dren Investigational Site 1

    RECRUITING

    Seoul, South Korea

  • Dren Investigational Site 2

    NOT_YET_RECRUITING

    New York, New York, 10032, United States

  • Dren Investigational Site 2

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • Dren Investigational Site 2

    RECRUITING

    Hong Kong, Hong Kong

  • Dren Investigational Site 2

    RECRUITING

    Busan, South Korea

  • Dren Investigational Site 2

    RECRUITING

    Seoul, South Korea

  • Dren Investigational Site 3

    RECRUITING

    Seoul, South Korea

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