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.
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…
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