140 Participants NeededMy employer runs this trial

ARC-02 + Rituximab for Non-Hodgkin's Lymphoma

(ABLATE-101 Trial)

Recruiting at 28 trial locations
TO
Overseen ByTaiho Oncology, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ARC-02 for people with B-cell Non-Hodgkin's Lymphoma, a type of blood cancer. The study explores the safety and effectiveness of ARC-02 when used alone or with Rituximab, a monoclonal antibody therapy. Researchers aim to understand how the body reacts to different doses and whether the treatment can help control the cancer. Participants should have a diagnosis of B-cell Non-Hodgkin's Lymphoma and have tried at least two other treatments without success. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial requires that you stop taking chemotherapy, radiotherapy, small molecule, investigational, and biologic agents at least 28 days before starting the study. It doesn't specify about other medications, so you should discuss your current medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Earlier research has shown that ARC-02 has a promising safety profile in lab studies. This treatment is being tested for certain blood cancers. Although human studies provide limited information, early tests suggest it might be well-tolerated.

When combined with rituximab, a drug often used for similar conditions, more safety information becomes available. Rituximab alone is generally well-tolerated. Some patients have experienced mild to moderate side effects, such as reactions during drug administration. Severe reactions are rare but can occur, especially during the first treatment.

In summary, ARC-02 has demonstrated a good safety profile in early tests, and rituximab is known to be mostly safe in humans. However, since ARC-02 remains in early trials, information on its safety in humans is limited.12345

Why are researchers excited about this trial's treatments?

ARC-02 is unique because it offers a novel approach to treating Non-Hodgkin's Lymphoma by potentially targeting cancer cells more precisely. Unlike standard treatments like R-CHOP or Rituximab alone, ARC-02 may provide a different mechanism of action, enhancing the body's ability to fight the disease. Researchers are particularly excited about its use in combination with Rituximab, as this combination could amplify the effectiveness of treatment by leveraging both ARC-02's new mechanism and Rituximab's established ability to target B-cell malignancies. This combined approach might lead to better outcomes and fewer side effects than traditional therapies.

What evidence suggests that this trial's treatments could be effective for Non-Hodgkin's Lymphoma?

Research has shown that ARC-02 could be a promising treatment for non-Hodgkin's lymphoma. Early studies suggest it has good potential, but its effectiveness in people is still under investigation. In this trial, some participants will receive ARC-02 alone, while others will receive it in combination with rituximab, a well-known treatment. Studies have indicated that combining rituximab with other treatments can lead to high success rates, sometimes up to 92%. This suggests that using ARC-02 with rituximab might be a strong option for treating non-Hodgkin's lymphoma.678910

Are You a Good Fit for This Trial?

This trial is for adults with certain types of B-cell non-Hodgkin's lymphoma, such as diffuse large B-cell, mantle cell, follicular, MALT lymphoma, or Waldenström's macroglobulinemia. Participants must meet specific health requirements and cannot join if they have conditions that would interfere with the study.

Inclusion Criteria

I am able to care for myself and do light activities.
I have tumors that can be measured by scans or exams.
Negative blood pregnancy test within 7 days prior to first dose of study intervention for women of childbearing potential
See 3 more

Exclusion Criteria

I have had lung disease or pneumonitis that needed treatment.
I have not received cancer treatments in the last 28 days.
Receiving an investigational product or participating in incompatible medical research
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ARC-02 monotherapy or in combination with Rituximab on Day 1 of each cycle until disease progression or unacceptable toxicity

Up to 5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ARC-02
  • Rituximab

Trial Overview

The study is testing a new drug called ARC-02 alone or in combination with rituximab to see how safe it is and how well it works in people with B-cell lymphomas. Researchers will also look at how the body processes these drugs.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Group I: Part B Dose Expansion: ARC-02 in Combination with RituximabExperimental Treatment2 Interventions
Group II: Part B Dose Escalation: ARC-02 in Combination with RituximabExperimental Treatment2 Interventions
Group III: Part A Dose Expansion: ARC-02 MonotherapyExperimental Treatment1 Intervention
Group IV: Part A Dose Escalation: ARC-02 MonotherapyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Taiho Oncology, Inc.

Lead Sponsor

Trials
79
Recruited
12,700+

Tim Whitten

Taiho Oncology, Inc.

Chief Executive Officer since 2018

MBA and Pharmacy degree

Harold Keer

Taiho Oncology, Inc.

Chief Medical Officer

MD, PhD

Citations

Impact of Rituximab on Non-Hodgkin Lymphoma Outcomes

Response rates were higher with rituximab-based therapy, with complete response rates of 62% with rituximab vs 49% without rituximab. The progression free ...

Non-Hodgkin Lymphoma Treatment (PDQ®) - NCBI - NIH

the median survival ranges from 8 to 15 years, 2-year OS rate of 38% the 5-year OS rate was 97%.[49][Level … failure-free survival rates were ...

Axi-Cel Shows Durable Responses, Curative Hope in Non- ...

Axi-cel demonstrated a 90% overall response rate and 75% complete response rate in relapsed/refractory indolent non-Hodgkin lymphoma. Median ...

Childhood Non-Hodgkin Lymphoma Treatment (PDQ®) - NCI

The 18-month complete response and PFS rates were 78%. a 3-year OS rate of 91%. The 4-year EFS rate was 70%, and the 3-year OS rate was 85%. ...

Who Benefits Most? Patient Selection Frameworks for CAR T ...

Another study observed complete remission in 43% of DLBCL patients and 71% of follicular lymphoma patients.79 These data confirm the correlation ...

Araris Biotech AG and Taiho Oncology Announce Dosing ...

“While ARC-02 is initially being developed for hematological malignancies, the differentiated safety profile observed in preclinical studies may ...

A CD79b Targeting ADC with Superior Anti-Tumor Activity and ...

ARC-02 is considered a promising next generation treatment alternative for patients suffering from Non-Hodgkin lymphoma (NHL).

FDA Approves ARC-02 IND Application for Non-Hodgkin ...

We have received FDA clearance for our #IND application supporting ARC-02, Araris Biotech AG's next-generation antibody-drug conjugate (#ADC) ...

NCT07691606 | A Study of ARC-02 in B-cell NHL

This study is to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary efficacy of ARC-02. Non-Hodgkins ...

Taiho's ADC ARC-02 Enters Phase 1 Trial

Taiho Oncology advances ARC-02, a CD79b-targeting antibody-drug conjugate, into Phase 1 clinical trials for non-Hodgkin lymphoma.