What side effects are associated with this type of intervention?

Common treatments for T-Cell Lymphoma, such as chemotherapy, monoclonal antibodies, and immunotherapy, often have significant side effects. Chemotherapy can cause myelosuppression, leading to anemia, neutropenia, and thrombocytopenia, as well as gastrointestinal symptoms like nausea and vomiting. Monoclonal antibodies, such as rituximab, can cause infusion reactions, which are more severe in the first cycle, especially in patients with high white blood cell counts. Immunotherapy, including checkpoint inhibitors like nivolumab and ipilimumab, can lead to immune-related adverse events such as skin reactions, endocrine disorders, and pneumonitis. These treatments aim to reduce tumor burden but require careful management of their side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for T-Cell Lymphoma that exhibit anti-tumor activity. Notable examples include brentuximab vedotin, an anti-CD30 monoclonal antibody-drug conjugate, and pralatrexate, a folate analog metabolic inhibitor. Additionally, romidepsin and belinostat, both histone deacetylase inhibitors, have been approved for relapsed or refractory T-Cell Lymphoma. These treatments, like DR-01, aim to target and reduce tumor activity in affected patients.

What other types of research exist?

Promising novel alternatives to DR-01 for T-Cell Lymphoma patients include: 1) Pembrolizumab and Nivolumab (immune checkpoint inhibitors targeting PD-1), 2) CAR-T cell therapies such as Axicabtagene Ciloleucel, and 3) targeted therapies like Brentuximab Vedotin (anti-CD30 antibody-drug conjugate). These treatments have shown efficacy in clinical trials and offer new avenues for managing T-Cell Lymphoma.

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Monoclonal Antibodies

DR-01 for Leukemia and Lymphoma

Q: What is the mechanism of action of this treatment?

The most common treatments for T-Cell Lymphoma include chemotherapy, immunotherapy, and targeted therapies. Chemotherapy works by killing rapidly dividing cells, including cancer cells, but can also affect normal cells, leading to side effects. Immunotherapy, such as checkpoint inhibitors, enhances the body's immune response against cancer cells by blocking proteins that inhibit immune activity. Targeted therapies, like tyrosine kinase inhibitors, specifically target molecular abnormalities in cancer cells, reducing damage to normal cells. These treatments are crucial for T-Cell Lymphoma patients as they aim to reduce tumor burden, improve survival rates, and offer options when traditional therapies fail.

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.

Must not have

History of clinically significant cardiac disease or congestive heart failure greater than New York Heart Association (NYHA) Class II.

Life-threatening, severe complications of malignancy (e.g., uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I do not have severe complications like uncontrolled bleeding or severe infections from my cancer.

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My condition is not due to a viral infection or associated with MDS or AML.

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I do not have any active infections requiring strong antibiotics, antivirals, or antifungals.

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I am infected with HIV.

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I am taking immunosuppressive drugs after a stem cell transplant.

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I have another active cancer besides the one being treated.

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I have not had major surgery in the last 28 days.

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My cancer has spread to my brain or is suspected to.

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I had a stem cell transplant from my own cells within 40 days or from a donor within 90 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for T-Cell Lymphoma include chemotherapy, immunotherapy, and targeted therapies. Chemotherapy works by killing rapidly dividing cells, including cancer cells, but can also affect normal cells, leading to side effects. Immunotherapy, such as checkpoint inhibitors, enhances the body's immune response against cancer cells by blocking proteins that inhibit immune activity. Targeted therapies, like tyrosine kinase inhibitors, specifically target molecular abnormalities in cancer cells, reducing damage to normal cells. These treatments are crucial for T-Cell Lymphoma patients as they aim to reduce tumor burden, improve survival rates, and offer options when traditional therapies fail.