Monoclonal Antibodies

DR-01 for T-Cell Lymphoma

Q: 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.

Q: 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.

Q: 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.

Dren Investigational Site, East Melbourne, Australia

Targeting 13 different conditionsDR-01Phase 1 & 2RecruitingResearch Sponsored by Dren Bio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must have failed at least two prior systemic regimens.

Be older than 18 years old

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upup to 25 months

Awards & highlights

No Placebo-Only Group

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

Select...

You have already tried two different treatments before participating in this study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 25 months

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.

0 / 1Eligibility criteria met

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

Recent research and studies

clinicaltrials.govStudy

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

2022. "A Study of DR-01 in Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05475925.