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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05475925
Other study ID # DR-01-ONC-001
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date July 13, 2022
Est. completion date December 2025

Study information

Verified date October 2023
Source Dren Bio
Contact Dren Central Contact
Phone 415-737-5277
Email clinops@drenbio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


Recruitment information / eligibility

Status Recruiting
Enrollment 69
Est. completion date December 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 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 two 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: Subjects must have radiographically measurable disease to be assessed by Lugano criteria. Subjects with primary cutaneous variants must have at least 1 measurable lesion that is evaluable using the Olsen criteria (Olsen 2021) or leukemic involvement that can be evaluated using a modified TPLL response criteria (Staber 2019). Subjects with hepatosplenic disease or other variants that do not have measurable disease by Lugano criteria (Cheson 2014) may be eligible upon discussion with the Medical Monitor if they have identifiable leukemic involvement in BM or peripheral blood (meeting the CD8+ cytotoxic phenotype definition) that can be evaluated for response using a modified TPLL response criteria (Staber 2019), or skin involvement that can be evaluated using Olsen criteria (Olsen 2021). 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 (e.g., >5 mg/day prednisone or equivalent for subjects with LGL leukemia (subjects on 20 mg prednisone or equivalent to treat LGL leukemia must be weaned within 28 days post C1D1 to 5 mg) and >10 mg/day prednisone or equivalent for subjects with cytotoxic lymphoma) within 15 days (except for prophylaxis for radiodiagnostic contrast reactions), or other non-biological immunosuppressive drugs within 15 days, prior to C1D1. Patients on stable prednisone =10 mg for documented rheumatologic/autoimmune conditions are exempted from this requirement. 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
DR-01
DR-01 is a non-fucosylated, human immunoglobulin G1 (IgG1) monoclonal antibody.

Locations

Country Name City State
Australia Dren Investigational Site Nedlands Western Australia
Australia Dren Investigational Site Richmond Victoria
France Dren Investigational Site Pierre-Bénite
France Dren Investigational Site Rennes
France Dren Investigational Site Toulouse
Spain Dren Investigational Site Barcelona
Spain Dren Investigational Site Salamanca
United States Dren Investigational Site Birmingham Alabama
United States Dren Investigational Site Charlottesville Virginia
United States Dren Investigational Site Columbus Ohio
United States Dren Investigational Site Duarte California
United States Dren Investigational Site Fairfax Virginia
United States Dren Investigational Site Houston Texas
United States Dren Investigational Site Jacksonville Florida
United States Dren Investigational Site New York New York
United States Dren Investigational Site Philadelphia Pennsylvania
United States Dren Investigational Site Phoenix Arizona
United States Dren Investigational Site Redwood City California
United States Dren Investigational Site Rochester Minnesota
United States Dren Investigational Site Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
Dren Bio Novotech

Countries where clinical trial is conducted

United States,  Australia,  France,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Part A: Safety and Tolerability. To determine the incidence and severity of adverse events as assessed by CTCAE v5.0. Up to 25 months
Primary Part A: Safety and Tolerability. To determine the incidence and severity of dose limiting toxicities (DLTs) as defined by protocol specified DLT criteria. During First 28 days (Cycle 1)
Primary 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. Up to 6 months
Primary 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. Up to 24 months
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