ONC-PluReceptor NK Cells for Non-Hodgkin's Lymphoma

YN
Overseen ByYago Nieto, MD,PHD
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: M.D. Anderson Cancer Center
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 ONC-PluReceptor NK cell therapy for individuals with B-cell Non-Hodgkin Lymphoma that has returned or resisted other treatments. It combines these NK cells, a type of immune cell therapy, with two monoclonal antibody therapies, epcoritamab and tafasitamab, to determine if they can better control the cancer. Researchers aim to assess the safety of this treatment for patients. Eligible participants have previously tried at least two different treatments or a stem cell transplant without success. As a Phase 1, Phase 2 trial, this research focuses on understanding the treatment's function in people and measuring its effectiveness in an initial, smaller group.

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

Research shows that ONC-PluReceptor NK cells are under evaluation for safety and effectiveness in treating B-cell Non-Hodgkin Lymphoma. Early results suggest that NK cell therapies, such as ONC-PluReceptor, hold promise and might serve as a viable alternative to treatments like CAR-T therapy.

Past studies have generally found NK cell therapies to be safe. While researchers continue to explore all safety aspects, these therapies have been well-tolerated in other trials. Some side effects have been reported, but they are usually manageable. Researchers are also investigating the combination of these NK cells with monoclonal antibodies, like epcoritamab and tafasitamab, to enhance effectiveness while maintaining safety.

As this trial is in its early stages, researchers closely monitor patient responses to ensure safety. This step is crucial to determine if the therapy can be safely used on a broader scale.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about ONC-PluReceptor NK cells for treating Non-Hodgkin's Lymphoma because they employ a novel approach that leverages the body's natural immune defenses. Unlike traditional chemotherapy or radiation, which directly attack cancer cells but can harm healthy tissues, ONC-PluReceptor NK cells are engineered to specifically enhance the body's natural killer (NK) cells, making them better at recognizing and destroying cancer cells. This targeted mechanism of action offers the potential for fewer side effects and improved outcomes. Additionally, the adaptability of these NK cells may provide a more personalized treatment strategy, which is a significant advancement over current one-size-fits-all therapies.

What evidence suggests that ONC-PluReceptor NK cell therapy might be an effective treatment for Non-Hodgkin's Lymphoma?

Research has shown that natural killer (NK) cell therapies, such as ONC-PluReceptor NK cells, hold promise for treating cancers, including Non-Hodgkin's Lymphoma. One study found that NK cell therapy from donors had a 92.9% success rate in helping patients with lymphoma, with most patients experiencing a reduction or disappearance of their cancer. This high success rate suggests NK cells can be very effective against difficult cancers. Early clinical trials have demonstrated that NK cell therapy is safe and effective, offering hope for patients with relapsed or hard-to-treat lymphoma. Participants in this trial will receive ONC-PluReceptor NK cells in various dose escalation and expansion cycles to evaluate their effectiveness and safety.14678

Who Is on the Research Team?

YN

Yago Nieto, MD,PHD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for people with B-cell Non-Hodgkin Lymphoma that has come back or hasn't responded to treatment. Participants must meet certain health criteria, which are not specified here.

Inclusion Criteria

Failure of \>/= 2 prior lines of therapy, or an autologous or allogeneic stem cell transplant.
Prior failure of CAR-T or not eligible for CAR-T cells.
2. Tumor biopsy positive for CD19 or CD20 at \>/= 1% by immunohistochemistry or flow cytometry.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ONC-PluReceptor NK cell therapy combined with epcoritamab and tafasitamab

12 weeks
Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person)

Long-term follow-up

Participants are monitored for long-term safety and survival outcomes

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • ONC-PluReceptor NK Cells

Trial Overview

The study tests ONC-PluReceptor NK cell therapy combined with monoclonal antibodies epcoritamab and tafasitamab, aiming to control relapsed/refractory B-cell Non-Hodgkin Lymphoma and evaluate safety.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: ESC/EXP1_Cycle 1: Dose Escalation/ Dose Expansion Treatment with ONC-PluReceptor NK cellsExperimental Treatment1 Intervention
Group II: Cycle 2: Dose Escalation/ Dose Expansion Treatment with ONC-PluReceptor NK cellsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Citations

Phase I/II Trial of ONC-PluReceptor NK Cells With ...

The goal of this clinical research study is to learn if ONC-PluReceptor NK cell therapy (combined with the monoclonal antibody therapies ...

Advances in Induced Pluripotent Stem Cell-Derived ...

Ex vivo IL-2-activated NK cells have shown better results than systemic IL-2 administration [34], but this approach has limited efficacy [42]. ...

Efficacy and safety of natural killer cell therapy in patients ...

Conclusion. This meta-analysis confirms the efficacy of NK cell administration in patients with solid tumors, demonstrating a significant increase in Overall ...

Allogeneic NK Cell Therapy Achieves 92% Response Rate ...

The study, published in Nature Medicine, showed an overall response rate of 92.9% and a complete response of 66.7% in a cohort of 42 heavily pretreated ...

Development of NK cell-based cancer immunotherapies ...

Early clinical trials have shown promising outcomes, alongside satisfactory product efficacy and safety. Recent developments have greatly ...

Phase I/II Trial of ONC-PluReceptor NK Cells With ...

Phase I/II Trial of ONC-PluReceptor NK Cells With Epcoritamab and Tafasitamab for Patients With Recurrent or Refractory B-cell Non-Hodgkin Lymphoma. P1/2.

Efficacy and safety of natural killer cell therapy in patients with ...

NK cell therapies represent a promising treatment option for solid tumors, offering a viable alternative to genetically modified cell therapies like CAR-T.

AD-PluReceptor NK Cells plus Tafasitamab-Cxix and ...

Giving PluReceptor NK cells plus tafasitamab-cxix and lymphodepleting chemotherapy may be safe and tolerable in treating patients with systemic sclerosis or ...