A Study of DR-01 in Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas

Recruiting Phase 1 Phase 2 Interventional Study
LGLL - Large Granular Lymphocytic Leukemia Primary Cutaneous Gamma-Delta T-Cell Lymphoma Primary Cutaneous CD8+ Aggressive Epidermotropic T-Cell Lymphoma Hepatosplenic T-cell Lymphoma Subcutaneous Panniculitis-Like T-Cell Lymphoma Aggressive NK Cell Leukemia Systemic EBV1 T-cell Lymphoma, if CD8 Positive Hydroa Vacciniforme-Like Lymphoproliferative Disorder Extranodal NK/T Cell Lymphoma, Nasal Type Enteropathy-Associated T-Cell Lymphoma Monomorphic Epitheliotropic Intestinal T-Cell Lymphoma Cytotoxic PTCL-NOS (CD8+ or CD56+ and Cytotoxic Marker) Cutaneous PTCL-NOS (CD8+ or CD56+ and Cytotoxic Marker)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
200 (estimated)
Sponsor
Dren Bio · Industry
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About This Trial

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

Trial Locations
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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 (postmenarchea…
Contacts

Dren Central Contact

415-737-5277

DR-01-ONC-001_inquiries@drenbio.com

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