Actively Recruiting
A Multicenter, Open-Label, First-In-Human Phase 1/2 Study to Evaluate the Safety and Efficacy of DR-01 in Adults With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas
Led by Dren Bio · Updated on 2026-04-17
200
Participants Needed
37
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of DR-01, a human monoclonal antibody, in adults with large granular lymphocytic leukemia or cytotoxic lymphomas. This multicenter, open-label, first-in-human Phase 1/2 study aims to find the optimal dose and regimen of DR-01 and assess its effects on these diseases. Participants will receive DR-01 at different dose levels ranging from 0.3 mg/kg to 10 mg/kg. Dosing regimens during the first month include bi-weekly dosing, doses on Days 1, 8, 15, and 29, or dosing on Days 1 to 5, 15, and 29. After the first month, monthly dosing continues for up to 25 cycles. The study has a dose escalation part to identify the best dose and regimen, followed by dose expansion parts to evaluate that dose in specific patient groups. During the study, researchers will monitor safety by tracking adverse events and dose-limiting toxicities, assess pharmacokinetics and pharmacodynamics, and evaluate anti-tumor responses using disease-specific criteria. Participants will undergo regular assessments including imaging scans and tissue biopsies when applicable. The total participation may last up to 25 months, with ongoing safety and efficacy evaluations throughout the study.
CONDITIONS
Brief Title
A Study of DR-01 in Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Able to understand and follow study procedures and provide informed consent
- Adequate organ function and blood clotting
- Women of childbearing potential must agree to use effective contraception during the study and for 12 months after last dose
- Male participants must agree to use effective contraception
- For large granular lymphocytic leukemia (LGLL) patients: must have stopped at least one prior systemic therapy
- LGLL patients must meet additional immunophenotypic and symptom criteria
- For cytotoxic lymphoma patients: must have failed at least one prior systemic treatment
- Must provide a post-progression tissue sample or agree to a baseline biopsy
- Histologically confirmed diagnosis of cytotoxic lymphoma by a hematopathologist
- For Part A: having measurable or evaluable disease is acceptable
- For Part B2: disease must be evaluable by specific imaging or response criteria depending on lymphoma subtype
You will not qualify if you...
- Reactive large granular lymphocyte lymphocytosis due to viral infection or associated with myelodysplastic syndrome or acute myeloid leukemia (for LGLL and aggressive NK cell leukemia)
- Active systemic or severe localized infection needing antibiotics, antivirals, or antifungals
- Active or suspected malignant involvement of the central nervous system
- Life-threatening severe complications of cancer such as uncontrolled bleeding or severe pneumonia
- Active second cancer
- Infection with HIV-1 or HIV-2
- Hepatitis B or C infection (except treated hepatitis C with undetectable virus)
- Significant heart disease or congestive heart failure worse than New York Heart Association Class II
- Use of high-dose systemic corticosteroids or other immunosuppressive drugs shortly before study start
- Conditions requiring hormonal therapy except contraception or hormone replacement
- Other medical or psychiatric conditions increasing study risk
- Unresolved toxicities from prior cancer treatments except specific exceptions
- Recent autologous or allogeneic stem cell transplant within specified timeframes
- Immunosuppressive therapy for graft-versus-host disease after allogeneic transplant
- Major surgery within 28 days before starting study treatment requiring more than local anesthesia or plexus blockades
- Any other condition deemed unsafe by the investigator or medical monitor for study participation
- Toxicities from previous anticancer therapies must have resolved to baseline or Grade 1 except alopecia, peripheral neuropathy, or allowed hematologic parameters
- Use of prohibited immunosuppressive drugs within 15 days or five half-lives before treatment start except specific exceptions
- Hormonal therapy restrictions as noted except for contraception or hormone replacement therapy
- Major surgery requiring significant anesthesia within 28 days before starting treatment
- Other medical or psychiatric conditions that increase risk as judged by investigators or medical monitor
- Recent hematopoietic stem cell transplantation within specified periods
- Immunosuppressive therapy for graft-versus-host disease in post-transplant subjects
- Active infections or malignancies as specified above
- HIV, hepatitis B or untreated hepatitis C infections as detailed above
- Severe heart disease excluding NYHA Class I-II
- Use of systemic corticosteroids or other immunosuppressive drugs close to treatment start
- Hormonal therapies unless allowed for contraception or replacement
- Unresolved toxicities or other safety concerns preventing safe participation
- Recent major surgery requiring more than local anesthesia or plexus blockade within 28 days before treatment start
- Reactive LGL lymphocytosis from viral infection or associated malignancies in specific subtypes
- Life-threatening complications of malignancy such as uncontrolled bleeding or pneumonia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 25 months
Participants receive DR-01 monoclonal antibody according to different dosing regimens during the first month, followed by monthly dosing for up to 25 cycles.
Multiple visits during the first month and monthly visits thereafter for up to 25 cycles
Trial Site Locations
Total: 37 locations
1
Dren Investigational Site
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Dren Investigational Site
Duarte, California, United States, 91010
Actively Recruiting
3
Dren Investigational Site
Irvine, California, United States, 92612
Actively Recruiting
4
Dren Investigational Site
Redwood City, California, United States, 94063
Actively Recruiting
5
Dren Investigational Site
New Haven, Connecticut, United States, 06519
Actively Recruiting
6
Dren Investigational Site
Tampa, Florida, United States, 33612
Actively Recruiting
7
Dren Investigational Site
Boston, Massachusetts, United States, 02114
Actively Recruiting
8
Dren Investigational Site 1
New York, New York, United States, 10021
Actively Recruiting
9
Dren Investigational Site 2
New York, New York, United States, 10032
Not Yet Recruiting
10
Dren Investigational Site
Columbus, Ohio, United States, 43210
Actively Recruiting
11
Dren Investigational Site 2
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
12
Dren Investigational Site
Houston, Texas, United States, 77030
Actively Recruiting
13
Dren Investigational Site
Charlottesville, Virginia, United States, 22903
Actively Recruiting
14
Dren Investigational Site
Fairfax, Virginia, United States, 22031
Actively Recruiting
15
Dren Investigational Site
Seattle, Washington, United States, 98109
Actively Recruiting
16
Dren Investigational Site
Clayton, Victoria, Australia, 3168
Actively Recruiting
17
Dren Investigational Site
Richmond, Victoria, Australia, 3121
Actively Recruiting
18
Dren Investigational Site
Nedlands, Washington, Australia, 6009
Actively Recruiting
19
Dren Investigational Site
Pierre-Bénite, France, 69310
Actively Recruiting
20
Dren Investigational Site
Rennes, France, 35000
Actively Recruiting
21
Dren Investigational Site
Toulouse, France, 31059
Actively Recruiting
22
Dren Investigational Site
Berlin, Germany, 10117
Actively Recruiting
23
Dren Investigational Site
Cologne, Germany, 50937
Actively Recruiting
24
Dren Investigational Site
Leipzig, Germany, 04103
Actively Recruiting
25
Dren Investigational Site 1
Hong Kong, Hong Kong, Hong Kong
Actively Recruiting
26
Dren Investigational Site 2
Hong Kong, Hong Kong
Actively Recruiting
27
Dren Investigational Site
Bologna, Italy, 40126
Actively Recruiting
28
Dren Investigational Site 1
Busan, South Korea
Actively Recruiting
29
Dren Investigational Site 2
Busan, South Korea
Actively Recruiting
30
Dren Investigational Site
Goyang-si, South Korea
Actively Recruiting
31
Dren Investigational Site 1
Seoul, South Korea
Actively Recruiting
32
Dren Investigational Site 2
Seoul, South Korea
Actively Recruiting
33
Dren Investigational Site 3
Seoul, South Korea
Actively Recruiting
34
Dren Investigational Site
Barcelona, Spain, 08035
Actively Recruiting
35
Dren Investigational Site
Salamanca, Spain, 37007
Actively Recruiting
36
Dren Investigational Site
Tainan, Taiwan
Actively Recruiting
37
Dren Investigational Site
Taipei, Taiwan
Actively Recruiting
Research Team
D
Dren Central Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here