Actively Recruiting
A Study of DR-01 in Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas
Led by Dren Bio · Updated on 2026-04-17
200
Participants Needed
37
Research Sites
228 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 comply with study procedures and voluntarily sign informed consent
- Adequate key organ function and coagulation
- Females of childbearing potential must agree to use highly effective contraception from enrollment through 12 months after last dose
- Males must agree to use effective contraception
- For LGLL patients: must have discontinued at least one prior systemic therapy
- For LGLL patients: must meet additional immunophenotypic and symptomatic criteria
- For cytotoxic lymphoma patients: must have failed at least one prior systemic regimen
- For cytotoxic lymphoma patients: must provide a post-progression tissue sample or consent to baseline biopsy
- Histologically confirmed diagnosis of cytotoxic lymphoma by hematopathologist per WHO 2016 classification
- For Part A: evaluable disease is acceptable
- For Part B2: disease must be measurable or evaluable by specified criteria depending on lymphoma subtype
You will not qualify if you...
- Reactive LGL lymphocytosis due to viral infection or LGL associated with myelodysplastic syndrome or acute myeloid leukemia
- Active systemic or severe localized infections requiring systemic treatment
- Active or suspected malignant central nervous system involvement
- Life-threatening severe complications of malignancy such as uncontrolled bleeding or pneumonia with hypoxia
- Active known second malignancy
- HIV infection
- Hepatitis B infection or active hepatitis C infection (treated HCV with undetectable virus allowed)
- History of significant cardiac disease or congestive heart failure greater than NYHA Class II
- Use of systemic corticosteroids at prohibited doses within 15 days prior to first dose (except for specific exceptions)
- Use of other non-biological immunosuppressives within 15 days or 5 half-lives prior to first dose
- Conditions requiring hormonal therapy except contraception, hormone replacement, or prophylaxis for prior malignancy
- Any medical or psychiatric condition or lab abnormality increasing study risk per investigator
- Toxicities from prior anticancer therapy must have resolved to baseline or Grade 1 except alopecia, neuropathy, or hematologic parameters
- Autologous HSCT within 40 days or allogeneic HSCT within 90 days before first dose
- Immunosuppressive therapy for GVHD post allogeneic HSCT
- Major surgery within 28 days prior to first dose requiring more than local anesthesia or plexus blockade
AI-Screening
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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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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