69 Participants Needed

DR-01 for Leukemia and Lymphoma

Recruiting at 41 trial locations
DC
Overseen ByDren Central Contact
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called DR-01 to see if it is safe and effective for adults with specific blood cancers. The study will check if the drug can safely reach and affect cancer cells to stop their growth.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop all current medications, but it does mention that you cannot use certain medications like systemic corticosteroids above specific doses within 15 days before starting the trial. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

What data supports the effectiveness of the drug DR-01 for leukemia and lymphoma?

Monoclonal antibodies, like DR-01, have been shown to be effective in treating various blood cancers, including leukemia and lymphoma, by targeting specific proteins on cancer cells. They are known for their unique action and fewer side effects, making them suitable for older patients or those with other health issues.12345

Is DR-01 safe for humans?

The research on non-fucosylated therapeutic antibodies, like DR-01, suggests they have a favorable safety profile and are well-tolerated in preclinical studies, indicating they may be safe for humans.46789

What makes the drug DR-01 unique for treating leukemia and lymphoma?

DR-01 is a monoclonal antibody that targets CD94, a specific protein on immune cells, which is different from other treatments that may target more common proteins like CD20 or CD19. This unique targeting could potentially offer a new approach for treating leukemia and lymphoma by focusing on a less commonly targeted pathway.910111213

Research Team

KD

Kimberley Dilley, MD, MPH

Principal Investigator

Dren Bio

Eligibility Criteria

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.

Inclusion Criteria

I have cytotoxic lymphoma and meet specific criteria numbers 8, 9, and 10.
For Part A only, evaluable disease is acceptable.
My lymphoma diagnosis is confirmed by a specialist according to WHO standards.
See 11 more

Exclusion Criteria

I have a serious heart condition worse than NYHA Class II.
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.
See 12 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Subjects receive DR-01 at various doses (0.3 to 10 mg/kg) with different regimens during the first month, followed by monthly dosing for up to 25 cycles

25 months
Multiple visits during the first month, monthly visits thereafter

Dose Expansion

Subjects receive the pharmacologically optimized dose/regimen determined in Part A for up to 25 doses

25 months
Multiple visits during the first month, monthly visits thereafter

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • DR-01
Trial OverviewThe 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

Dren Bio

Lead Sponsor

Trials
6
Recruited
280+

Novotech Health Holdings Pte. Ltd.

Industry Sponsor

Trials
1
Recruited
330+

ProTrials Research Inc.

Collaborator

Trials
1
Recruited
70+

Novotech

Collaborator

Trials
2
Recruited
80+

Findings from Research

Monoclonal antibodies represent a new treatment option for lymphoma, working through immunologic mechanisms to induce tumor lysis rather than causing DNA damage like traditional chemotherapy.
These antibodies have a favorable side effect profile and show significant effectiveness in treating chemoresistant lymphoma, suggesting they could be used alongside traditional therapies for better outcomes.
The role of monoclonal antibodies in the treatment of lymphomas.Hsu, JW., Dang, NH.[2013]
Monoclonal antibodies (MAbs) are being improved to enhance their effectiveness in treating hematologic malignancies, with three promising classes identified: unconjugated MAbs, drug-conjugated MAbs that deliver cytotoxic drugs directly to tumors, and radioactive immunotherapy that targets tumors with radiation.
Advancements in understanding how MAbs are metabolized and localized in the body are leading to the development of new antibody constructs that have better distribution profiles, potentially increasing their therapeutic efficacy.
Future of monoclonal antibodies in the treatment of hematologic malignancies.Reff, ME., Hariharan, K., Braslawsky, G.[2017]
Monoclonal antibodies have transformed cancer research and treatment by providing critical tools for understanding cancer cell behavior and are now essential in diagnosing and treating various cancers, particularly hematological malignancies.
This review specifically highlights the application of monoclonal antibodies in treating acute myeloid leukemia and mature B-cell neoplasms, showcasing their importance in modern cancer therapies.
Monoclonal antibodies in the treatment of hematologic malignancy.Ball, ED., Broome, HE.[2010]

References

The role of monoclonal antibodies in the treatment of lymphomas. [2013]
Future of monoclonal antibodies in the treatment of hematologic malignancies. [2017]
Monoclonal antibodies in the treatment of hematologic malignancy. [2010]
Antibody therapy of acute and chronic leukemias. [2019]
Monoclonal antibody therapy for lymphoma. [2019]
Defucosylated chimeric anti-CC chemokine receptor 4 IgG1 with enhanced antibody-dependent cellular cytotoxicity shows potent therapeutic activity to T-cell leukemia and lymphoma. [2020]
Preclinical evaluation of a novel antibody-drug conjugate targeting DR5 for lymphoblastic leukemia therapy. [2021]
Non-fucosylated therapeutic antibodies as next-generation therapeutic antibodies. [2020]
Immunotoxins for leukemia. [2022]
Monoclonal antibody NU-B1 reacts with novel antigen on human B cells in mantle and marginal zones distinct from known CD molecules. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Immunologic classification of leukemia and lymphoma. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
Laboratory and clinical applications of monoclonal antibodies for leukemias and non-Hodgkin's lymphomas. [2019]
Monoclonal antibody studies in B(non-T)-cell malignancies. [2007]