DR-01 for Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Dren Investigational Site, East Melbourne, Australia
Lymphoma+26 More
DR-01 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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

Eligible Conditions

  • Other CD8+/NK Cell Driven Lymphoma Not Listed Above
  • Lymphoma
  • Hydroa Vacciniforme-Like Lymphoproliferative Disorder
  • Primary Cutaneous CD8-Positive Aggressive Epidermotropic T-Cell Lymphoma
  • Enteropathy-Associated T-Cell Lymphoma
  • Hepatosplenic T-cell Lymphoma
  • Systemic EBV1 T-cell Lymphoma, if CD8 Positive
  • Indolent Chronic Lymphoproliferative Disorder (CLPD) (CD8+ or NK Derived) of the GI Tract
  • LGLL - Large Granular Lymphocytic Leukemia
  • Aggressive NK Cell Leukemia
  • T-Cell Lymphoma
  • Primary Cutaneous T-Cell Lymphoma - Category
  • Primary Cutaneous Acral CD8-Positive T-Cell Lymphoma
  • Monomorphic Epitheliotropic Intestinal T-Cell Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

5 Primary · 0 Secondary · Reporting Duration: Up to 25 months

Day 28
Part A: Safety and Tolerability. To determine the incidence and severity of dose limiting toxicities (DLTs) as defined by protocol specified DLT criteria.
Up to 1 month
Part A: Max tolerated dose of DR-01 (if applicable).
Up to 24 months
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 25 months
Part A: Safety and Tolerability. To determine the incidence and severity of adverse events as assessed by CTCAE v5.0.
Up to 6 months
Part A: Recommended Phase 2 dose (RP2D) of DR-01 in LGL leukemia and cytotoxic lymphoma populations as determined by integrated assessment of target engagement/attainment, efficacy, safety, PK/PD, and exposure-response relationships.

Trial Safety

Safety Progress

1 of 3

Trial Design

7 Treatment Groups

Part A Dose Escalation (Cohort 1) 1 mg/kg of DR-01
1 of 7
Part B Dose Expansion (Cohort B1) RP2D of DR-01
1 of 7
Part A Dose De-escalation (Cohort -1) 0.3 to <1 mg/kg of DR-01
1 of 7
Part A Dose Escalation (Cohort 4) 10 mg/kg of DR-01
1 of 7
Part A Dose Escalation (Cohort 2) 3 mg/kg of DR-01
1 of 7
Part A Dose Escalation (Cohort 3) 6 mg/kg of DR-01
1 of 7
Part B Dose Expansion (Cohort B2) RP2D of DR-01
1 of 7
Experimental Treatment

69 Total Participants · 7 Treatment Groups

Primary Treatment: DR-01 · No Placebo Group · Phase 1 & 2

Part A Dose Escalation (Cohort 1) 1 mg/kg of DR-01
Drug
Experimental Group · 1 Intervention: DR-01 · Intervention Types: Drug
Part B Dose Expansion (Cohort B1) RP2D of DR-01
Drug
Experimental Group · 1 Intervention: DR-01 · Intervention Types: Drug
Part A Dose De-escalation (Cohort -1) 0.3 to <1 mg/kg of DR-01
Drug
Experimental Group · 1 Intervention: DR-01 · Intervention Types: Drug
Part A Dose Escalation (Cohort 4) 10 mg/kg of DR-01
Drug
Experimental Group · 1 Intervention: DR-01 · Intervention Types: Drug
Part A Dose Escalation (Cohort 2) 3 mg/kg of DR-01
Drug
Experimental Group · 1 Intervention: DR-01 · Intervention Types: Drug
Part A Dose Escalation (Cohort 3) 6 mg/kg of DR-01
Drug
Experimental Group · 1 Intervention: DR-01 · Intervention Types: Drug
Part B Dose Expansion (Cohort B2) RP2D of DR-01
Drug
Experimental Group · 1 Intervention: DR-01 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 25 months
Closest Location: Dren Investigational Site · Duarte, CA
Photo of Duarte 1Photo of Duarte 2Photo of Duarte 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Lymphoma
0 CompletedClinical Trials

Who is running the clinical trial?

Dren BioLead Sponsor
NovotechUNKNOWN
ProTrials Research Inc.UNKNOWN
Matthias Will, MDStudy DirectorDren Bio
2 Previous Clinical Trials
152 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are 18 years of age or older.
You are able to understand and comply with protocol-required study procedures and voluntarily sign a written informed consent document.
Subjects with LGLL must also meet inclusion criteria 6 and 7.
Subjects with cytotoxic lymphomas must also meet inclusion criteria 8,9, and 10.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.