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

ConditionsLGLL - Large Granular Lymphocytic LeukemiaPrimary Cutaneous Gamma-Delta T-Cell LymphomaPrimary Cutaneous CD8+ Aggressive Epidermotropic T-Cell LymphomaHepatosplenic T-cell LymphomaSubcutaneous Panniculitis-Like T-Cell LymphomaAggressive NK Cell LeukemiaSystemic EBV1 T-cell Lymphoma, if CD8 PositiveHydroa Vacciniforme-Like Lymphoproliferative DisorderExtranodal NK/T Cell Lymphoma, Nasal TypeEnteropathy-Associated T-Cell LymphomaMonomorphic Epitheliotropic Intestinal T-Cell LymphomaCytotoxic PTCL-NOS (CD8+ or CD56+ and Cytotoxic Marker)Cutaneous PTCL-NOS (CD8+ or CD56+ and Cytotoxic Marker)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDren Bio

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 years of age.

Able to understand and comply with protocol-required study procedures and voluntarily sign a written informed consent document.

Sufficient key organ performance and coagulation.

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.

Disqualifiers

A reactive LGL lymphocytosis to a viral infection or LGL associated with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).

Active systemic infection or severe localized infection requiring systemic antibiotics, antivirals or antifungals.

Active or suspected malignant central nervous system involvement.

Life-threatening, severe complications of malignancy (e.g., uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation).

Trial design

Design model

Sequential

Treatments tested in this trial

  • DR-01

    Drug

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

Treatment groups

200 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Part A Dose Escalation 1 mg/kg of DR-01Experimental treatment 1 intervention
Group B: Part A Dose Escalation 3 mg/kg of DR-01Experimental treatment 1 intervention
Group C: Part A Dose Escalation 6 mg/kg of DR-01Experimental treatment 1 intervention
Group D: Part A Dose Escalation 10 mg/kg of DR-01Experimental treatment 1 intervention
Group E: Part A Dose De-escalation 0.3 to <1 mg/kg of DR-01Experimental treatment 1 intervention
Group F: Part B Dose Expansion (Cohort B1) Optimized Dose/Regimen of DR-01Experimental treatment 1 intervention
Group G: Part B Dose Expansion (Cohort B2) Optimized Dose/Regimen of DR-01Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part A: Safety and Tolerability. To determine the incidence and severity of adverse events as assessed by CTCAE v5.0.

Time frame
Up to 25 months
2

Part A: Safety and Tolerability. To determine the incidence and severity of dose limiting toxicities (DLTs) as defined by protocol specified DLT criteria.

Time frame
During First 28 days (Cycle 1)
3

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.

Time frame
Up to 6 months
4

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.

Time frame
Up to 24 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dren Bio

Lead sponsor

Source ClinicalTrials.gov
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