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

Conditions

• Aggressive NK Cell Leukemia
• Cutaneous PTCL-NOS (CD8+ or CD56+ and Cytotoxic Marker)
• Cytotoxic PTCL-NOS (CD8+ or CD56+ and Cytotoxic Marker)
• Enteropathy-Associated T-Cell Lymphoma
• Extranodal NK/T Cell Lymphoma, Nasal Type
• Hepatosplenic T-cell Lymphoma
• Hydroa Vacciniforme-Like Lymphoproliferative Disorder
• LGLL - Large Granular Lymphocytic Leukemia
• Monomorphic Epitheliotropic Intestinal T-Cell Lymphoma
• Primary Cutaneous CD8+ Aggressive Epidermotropic T-Cell Lymphoma
• Primary Cutaneous Gamma-Delta T-Cell Lymphoma
• Subcutaneous Panniculitis-Like T-Cell Lymphoma
• Systemic EBV1 T-cell Lymphoma, if CD8 Positive

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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

Key Dates

Start date

Jul 13, 2022

Status verified

Apr 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

200 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part A Dose Escalation 1 mg/kg of DR-01
  Subjects in this arm will initially receive 1 mg/kg at either the Primary regimen (bi-weekly dosing for fist month), Secondary regimen (doses at Days 1, 8, 15, 29 during first month), or Tertiary regimen (dosing days 1-5, 15, 29 during first month), followed by monthly dosing (up to 6 mg/kg) thereafter for up to 25 cycles total.
• Experimental: Part A Dose Escalation 3 mg/kg of DR-01
  Subjects in this arm will initially receive 3 mg/kg at either the Primary regimen (bi-weekly dosing for fist month), Secondary regimen (doses at Days 1, 8, 15, 29 during first month), or Tertiary regimen (dosing days 1-5, 15, 29 during first month), followed by monthly dosing (up to 10 mg/kg) thereafter for up to 25 cycles total.
• Experimental: Part A Dose Escalation 6 mg/kg of DR-01
  Subjects in this arm will initially receive 6 mg/kg at either the Primary regimen (bi-weekly dosing for fist month), Secondary regimen (doses at Days 1, 8, 15, 29 during first month), or Tertiary regimen (dosing days 1-5, 15, 29 during first month), followed by monthly dosing (up to 10 mg/kg) thereafter for up to 25 cycles total.
• Experimental: Part A Dose Escalation 10 mg/kg of DR-01
  Subjects in this arm will initially receive 10 mg/kg at either the Primary regimen (bi-weekly dosing for fist month), Secondary regimen (doses at Days 1, 8, 15, 29 during first month), or Tertiary regimen (dosing days 1-5, 15, 29 during first month), followed by monthly dosing (up to 10 mg/kg) thereafter for up to 25 cycles total.
• Experimental: Part A Dose De-escalation 0.3 to <1 mg/kg of DR-01
  This cohort would only be triggered should a DLT occur at Dose Level 1 or if recommended by the Safety Review Committee. Subjects in this arm would initially receive 0.3 to \<1 mg/kg at either the Primary regimen (bi-weekly dosing for fist month), Secondary regimen (doses at Days 1, 8, 15, 29 during first month), or Tertiary regimen (dosing days 1-5, 15, 29 during first month), followed by monthly dosing (up to 3 mg/kg) thereafter for up to 25 cycles total.
• Experimental: Part B Dose Expansion (Cohort B1) Optimized Dose/Regimen of DR-01
  Subjects in this arm will receive the pharmacologically optimized dose/regimen for LGL leukemia subjects determined in Part A. Depending on the selected dose/regimen, subjects will receive target dose at either the Primary regimen (bi-weekly dosing for fist month), Secondary regimen (doses at Days 1, 8, 15, 29 during first month), or Tertiary regimen (dosing days 1-5, 15, 29 during first month), followed by monthly dosing thereafter for up to 25 doses total.
• Experimental: Part B Dose Expansion (Cohort B2) Optimized Dose/Regimen of DR-01
  Subjects in this arm will receive the pharmacologically optimized dose/regimen for cytotoxic lymphoma subjects determined in Part A. Depending on the selected dose/regimen, subjects will receive target dose at either the Primary regimen (bi-weekly dosing for fist month), Secondary regimen (doses at Days 1, 8, 15, 29 during first month), or Tertiary regimen (dosing days 1-5, 15, 29 during first month), followed by monthly dosing thereafter for up to 25 doses total.

Primary Outcome Measure

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 ]

Central Contacts

• Dren Central Contact
  415-737-5277
  [email protected]

Locations (15)

Find similar trials in Birmingham, AL

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