Monoclonal Antibodies

DR-01 for T-Cell Lymphoma

Dren Investigational Site, East Melbourne, Australia
Targeting 13 different conditionsDR-01Phase 1 & 2RecruitingResearch Sponsored by Dren Bio

Study Summary

This trial is testing a new drug, DR-01, to treat adults with large granular lymphocytic leukemia or cytotoxic lymphomas. The goal is to see if it is safe and effective.

Eligible Conditions
  • T-Cell Lymphoma
  • Cutaneous T-Cell Lymphoma
  • Mycosis Fungoides
  • Hepatosplenic T-cell Lymphoma
  • Natural Killer Cell Leukemia
  • Systemic T-cell Lymphoma
  • Nasal Lymphoma
  • Intestinal T-Cell Lymphoma
  • CD8+/NK Cell Lymphoma
  • Large Granular Lymphocytic Leukemia
  • Hydroa Vacciniforme-Like Lymphoproliferative Disorder
  • Chronic Lymphoproliferative Disorder of the Gastrointestinal Tract

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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You have already tried two different treatments before participating in this study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 25 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 25 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A: Safety and Tolerability. To determine the incidence and severity of adverse events as assessed by CTCAE v5.0.
Part A: Safety and Tolerability. To determine the incidence and severity of dose limiting toxicities (DLTs) as defined by protocol specified DLT criteria.
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.
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

7Treatment groups
Experimental Treatment
Group I: Part B Dose Expansion (Cohort B2) Optimized Dose/Regimen of DR-01Experimental Treatment1 Intervention
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.
Group II: Part B Dose Expansion (Cohort B1) Optimized Dose/Regimen of DR-01Experimental Treatment1 Intervention
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.
Group III: Part A Dose Escalation 6 mg/kg of DR-01Experimental Treatment1 Intervention
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.
Group IV: Part A Dose Escalation 3 mg/kg of DR-01Experimental Treatment1 Intervention
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.
Group V: Part A Dose Escalation 10 mg/kg of DR-01Experimental Treatment1 Intervention
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.
Group VI: Part A Dose Escalation 1 mg/kg of DR-01Experimental Treatment1 Intervention
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.
Group VII: Part A Dose De-escalation 0.3 to <1 mg/kg of DR-01Experimental Treatment1 Intervention
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.

Find a site

Who is running the clinical trial?

Dren BioLead Sponsor
ProTrials Research Inc.UNKNOWN
NovotechUNKNOWN
Matthias Will, MDStudy Director
Dren Bio
2 Previous Clinical Trials
152 Total Patients Enrolled
Kimberley Dilley, MD, MPHStudy Director
Dren Bio

Media Library

DR-01 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05475925 — Phase 1 & 2
T-Cell Lymphoma Research Study Groups: Part A Dose Escalation 1 mg/kg of DR-01, Part A Dose Escalation 3 mg/kg of DR-01, Part A Dose Escalation 6 mg/kg of DR-01, Part A Dose Escalation 10 mg/kg of DR-01, Part A Dose De-escalation 0.3 to <1 mg/kg of DR-01, Part B Dose Expansion (Cohort B1) Optimized Dose/Regimen of DR-01, Part B Dose Expansion (Cohort B2) Optimized Dose/Regimen of DR-01
T-Cell Lymphoma Clinical Trial 2023: DR-01 Highlights & Side Effects. Trial Name: NCT05475925 — Phase 1 & 2
DR-01 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05475925 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total enrollment of participants for this clinical research?

"Affirmative. Clinicaltrials.gov provides evidence that this medical trial is presently recruiting and has been since 13 July 2022, with the latest update on 6 September of the same year. 69 patients need to be sourced from 8 sites."

Answered by AI

How many establishments are carrying out this trial?

"Currently, this research study is actively recruiting patients from 8 locations across the United States; these include Columbus, Fairfax and Houston among other cities. To reduce travel burden associated with enrolment it is wise to select a site closest to you."

Answered by AI

Are there opportunities for enrolment in this research framework?

"Affirmative. The clinicaltrials.gov platform shows that this medical experiment is presently recruiting, having been initially posted on July 13th 2022 and last updated September 6th 2022. A total of 69 patients are needed across 8 sites for the trial to reach completion."

Answered by AI
~34 spots leftby Dec 2024