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Monoclonal Antibodies
DR-01 for Leukemia and Lymphoma
Phase 1 & 2
Recruiting
Research Sponsored by Dren Bio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed diagnosis of a cytotoxic lymphoma by a hematopathologist (according to the WHO 2016 classification [Swerdlow 2016]).
Subjects must have failed at least two prior systemic regimens.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 25 months
Awards & highlights
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.
Who is the study for?
Adults with large granular lymphocytic leukemia or cytotoxic lymphomas who have tried at least one other treatment can join this trial. They must be over 18, meet specific diagnostic criteria, and have a certain level of organ function. Women able to bear children and men must use effective birth control. People with HIV, hepatitis B/C, severe heart issues, recent major surgery or those on high-dose steroids are excluded.Check my eligibility
What is being tested?
The study is testing DR-01's safety and effectiveness in treating certain blood cancers. It's the first time humans will try it (Phase 1/2). The trial involves multiple centers where participants' reactions to the drug are closely monitored for any signs of improvement in their condition.See study design
What are the potential side effects?
Since this is a first-in-human study for DR-01, potential side effects aren't fully known yet but may include typical reactions related to cancer treatments such as fatigue, nausea, immune system effects or infusion-related responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lymphoma diagnosis is confirmed by a specialist according to WHO standards.
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I have tried at least two different treatments without success.
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I can and will use effective birth control for 12 months after my last dose.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 25 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 25 months
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 moreTrial 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 Location
Who is running the clinical trial?
Dren BioLead Sponsor
1 Previous Clinical Trials
48 Total Patients Enrolled
ProTrials Research Inc.UNKNOWN
NovotechUNKNOWN
1 Previous Clinical Trials
48 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a serious heart condition worse than NYHA Class II.I have cytotoxic lymphoma and meet specific criteria numbers 8, 9, and 10.My lymphoma diagnosis is confirmed by a specialist according to WHO standards.My vital organs are functioning well and my blood clots normally.I have tried at least two different treatments without success.I do not have severe complications like uncontrolled bleeding or severe infections from my cancer.I am on hormonal therapy not related to contraception, hormone replacement, or cancer prevention.I am infected with HIV.I have hepatitis B or C, but if it's hepatitis C, it's undetectable after treatment.My disease can be measured using specific medical criteria.My condition is not due to a viral infection or associated with MDS or AML.I can and will use effective birth control for 12 months after my last dose.I haven't taken high doses of steroids or immune-weakening drugs in the last 15 days.I do not have any active infections requiring strong antibiotics, antivirals, or antifungals.I am taking immunosuppressive drugs after a stem cell transplant.Side effects from my past cancer treatments have mostly gone away.I have another active cancer besides the one being treated.I have not had major surgery in the last 28 days.My cancer has spread to my brain or is suspected to.I have stopped at least one previous systemic treatment.I am 18 years old or older.I had a stem cell transplant from my own cells within 40 days or from a donor within 90 days.I understand the study requirements and agree to participate.I agree to use effective birth control methods.If you have any other medical or mental health conditions or abnormalities in your lab results that could make participating in the study risky, the investigator or medical monitor may exclude you.
Research Study Groups:
This trial has the following groups:- Group 1: Part A Dose Escalation 6 mg/kg of DR-01
- Group 2: Part B Dose Expansion (Cohort B2) Optimized Dose/Regimen of DR-01
- Group 3: Part A Dose Escalation 1 mg/kg of DR-01
- Group 4: Part A Dose Escalation 3 mg/kg of DR-01
- Group 5: Part A Dose De-escalation 0.3 to <1 mg/kg of DR-01
- Group 6: Part B Dose Expansion (Cohort B1) Optimized Dose/Regimen of DR-01
- Group 7: Part A Dose Escalation 10 mg/kg of DR-01
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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