A Study of DR-01 in Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests DR-01 in adults with large granular lymphocytic leukemia (LGLL) or cytotoxic lymphomas, types of blood cancer. It is the first study of DR-01 in people and looks at its safety, how it works in the body, and whether it fights cancer.
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
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be at least 18, understand and follow study steps, and freely sign a consent form.
- Have key organs and blood clotting that work well enough.
- Women who can become pregnant must use highly effective birth control during the study and for at least 12 months after the last dose. Men must use acceptable, effective birth control.
- For LGLL: have stopped at least one treatment that works throughout the body. Meet extra rules about symptoms and markers on immune cells.
- For cytotoxic lymphoma: have had at least one treatment that works throughout the body fail. A blood cancer specialist must confirm the diagnosis by checking tissue.
- For cytotoxic lymphoma: have a tissue sample from after the cancer got worse, or agree to have a tissue sample taken before treatment.
- For Part A: have cancer that can be checked to see how it responds.
- For Part B2: meet rules for checking cancer response based on the lymphoma type. These may involve scans, skin spots, blood, or bone marrow.
Who can't join
- For LGLL or ANKL: increased LGL immune cells caused by a virus, or LGL linked to myelodysplastic syndrome or acute myeloid leukemia, other blood disorders.
- An active infection throughout the body or a severe local infection needing medicines; HIV; hepatitis B; or hepatitis C. Treated hepatitis C is allowed if the virus can no longer be detected.
- Known or suspected cancer in the brain or spinal cord, another active cancer, or life-threatening cancer problems such as uncontrolled bleeding.
- A history of serious heart disease, heart failure above the study's limit, or another health, mental health, or lab problem that makes joining unsafe.
- Recent use of steroids above allowed doses or other medicines that weaken the immune system. Some steroid uses are allowed. Hormone treatment is not allowed except for birth control, hormone replacement, or preventing a past cancer from returning.
- Side effects from past cancer treatment that have not returned to usual levels or become mild. Exceptions include hair loss, nerve damage, and blood counts that meet study rules.
- A stem cell transplant using your own cells within 40 days before the first dose, or donor cells within 90 days. Immune-weakening treatment for graft-versus-host disease, when donor cells attack your body, is also not allowed.
- Major surgery within 28 days before the first dose.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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).
Study sites (15)
AL
- Dren Investigational Site · Birmingham, AL 35233Dren Central Contact · Study contact · 415-735-5277 · DR-01-ONC-001_inquiries@drenbio.comMore trials in Birmingham
CA
- Dren Investigational Site · Duarte, CA 91010Dren Central Contact · Study contact · 415-737-5277 · DR-01-ONC-001_inquiries@drenbio.comMore trials in Duarte
- Dren Investigational Site · Irvine, CA 92612Dren Central Contact · Study contact · 415-737-5277 · DR-01-ONC-001_inquiries@drenbio.comMore trials in Irvine
- Dren Investigational Site · Redwood City, CA 94063Dren Central Contact · Study contact · 415-735-5277 · DR-01-ONC-001_inquiries@drenbio.comMore trials in Redwood City
CT
- Dren Investigational Site · New Haven, CT 06519Dren Central Contact · Study contact · 415-737-5277 · DR-01-ONC-001_inquiries@drenbio.comMore trials in New Haven
FL
- Dren Investigational Site · Tampa, FL 33612Dren Central Contact · Study contact · 415-737-5277 · DR-01-ONC-001_inquiries@drenbio.comMore trials in Tampa
MA
- Dren Investigational Site · Boston, MA 02114Dren Central Contact · Study contact · 415-735-5277 · DR-01-ONC-001_inquiries@drenbio.comMore trials in Boston
NY
- Dren Investigational Site 1 · New York, NY 10021Dren Central Contact · Study contact · 415-735-5277 · DR-01-ONC-001_inquiries@drenbio.comMore trials in New York
- Dren Investigational Site 2 · New York, NY 10032Dren Central Contact · Study contact · 415-737-5277 · DR-01-ONC-001_inquiries@drenbio.comMore trials in New York
OH
- Dren Investigational Site · Columbus, OH 43210Dren Central Contact · Study contact · 415-735-5277 · DR-01-ONC-001_inquiries@drenbio.comMore trials in Columbus
PA
- Dren Investigational Site 2 · Pittsburgh, PA 15213Dren Central Contact · Study contact · 415-737-5277 · DR-01-ONC-001_inquiries@drenbio.comMore trials in Pittsburgh
TX
- Dren Investigational Site · Houston, TX 77030Dren Central Contact · Study contact · 415-737-5277 · DR-01-ONC-001_inquiries@drenbio.comMore trials in Houston
VA
- Dren Investigational Site · Charlottesville, VA 22903Dren Central Contact · Study contact · 415-735-5277 · DR-01-ONC-001_inquiries@drenbio.comMore trials in Charlottesville
- Dren Investigational Site · Fairfax, VA 22031Dren Central Contact · Study contact · 415-737-5277 · DR-01-ONC-001_inquiries@drenbio.comMore trials in Fairfax
WA
- Dren Investigational Site · Seattle, WA 98109Dren Cntral Contact · Study contact · 415-737-5277 · DR-01-ONC-001_inquiries@drenbio.comMore trials in Seattle