MT-601 for Pancreatic Cancer

(PANACEA Trial)

PA
KH
Overseen ByKaylor Hopkins
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Marker Therapeutics, Inc.
Must be taking: FFX, NLX
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 the safety and effects of a new treatment called MT-601 for individuals with pancreatic cancer. It examines the efficacy of different MT-601 doses administered during a chemotherapy break. Those with inoperable or metastatic pancreatic cancer, who have undergone specific chemotherapy treatments without cancer progression, may qualify for this trial. Participants must agree to provide certain blood samples for the study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are on systemic steroid therapy, you must stop it at least 7 days before starting the trial.

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

Research has shown that MT-601 is generally safe for patients. Studies found no serious side effects, such as severe reactions during infusion or nerve damage. One study reported that up to 84.6% of patients had their disease under control, indicating that MT-601 is usually well-tolerated. This treatment targets specific proteins in pancreatic cancer, allowing it to work effectively without significantly harming healthy cells. Although this trial remains in the early stages, current evidence suggests that MT-601 is a safe option for many patients.12345

Why do researchers think this study treatment might be promising for pancreatic cancer?

Researchers are excited about MT-601 for pancreatic cancer because it uses a novel approach involving cell-based therapy. Unlike standard treatments like chemotherapy and radiation, which target cancer cells directly, MT-601 works by harnessing the power of modified immune cells, potentially offering a more targeted attack on the tumor. This treatment involves different doses, from 200 million to 1200 million cells, allowing researchers to find the most effective dose. The idea is that by boosting the body's own immune response, MT-601 might provide a more precise and potentially less harmful way to combat pancreatic cancer.

What evidence suggests that MT-601 might be an effective treatment for pancreatic cancer?

Studies have shown that MT-601 has a promising effect on pancreatic cancer. In earlier trials, 84.6% of patients achieved disease control, meaning their cancer did not worsen. The cancer shrank in 15.4% of patients, and 7.7% experienced a complete response, with no detectable cancer. Additionally, MT-601 stopped cancer growth in 61.5% of patients. These results suggest that MT-601 could effectively manage pancreatic cancer by controlling its growth. Participants in this trial will receive different doses of MT-601 to further evaluate its effectiveness and safety.12367

Who Is on the Research Team?

PA

Patricia Allison, BS

Principal Investigator

Marker Therapeutics

Are You a Good Fit for This Trial?

This trial is for adults with newly diagnosed, locally advanced or metastatic pancreatic adenocarcinoma that can't be removed by surgery. Participants must have responded to initial chemotherapy, have good general health and organ function, and be able to provide blood cells for making the treatment.

Inclusion Criteria

My platelet count is at least 75,000 per microliter.
I have newly diagnosed advanced or metastatic pancreatic adenocarcinoma.
I had stable disease or tumor shrinkage after 2 months of first chemotherapy.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Determine an acceptable dose of MT-601 in combination with maintenance capecitabine following completion of FFX or NLX chemotherapy using a modified 3+3 design

24 months

Dose Expansion

Administer MT-601 at the dose determined to be safe based on the results from the Dose Escalation portion

2.5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • MT-601

Trial Overview

The study tests different doses of MT-601 (a cell therapy) given during breaks from standard chemotherapy. The main goals are to see if MT-601 is safe at increasing doses and how well it works against pancreatic cancer.

How Is the Trial Designed?

5

Treatment groups

Experimental Treatment

Group I: Dose ExpansionExperimental Treatment4 Interventions
Group II: Cohort 3 / MT-601 1200 million cellsExperimental Treatment1 Intervention
Group III: Cohort 2 / MT-601 800 million cellsExperimental Treatment1 Intervention
Group IV: Cohort 1 / MT-601 dose 400 million cellsExperimental Treatment1 Intervention
Group V: Cohort -1 / MT-601 dose 200 million cellsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Marker Therapeutics, Inc.

Lead Sponsor

Trials
8
Recruited
450+

M.D. Anderson Cancer Center

Collaborator

Trials
3,107
Recruited
1,813,000+

Citations

Baylor College of Medicine Publishes Promising Safety ...

Clinical study from Baylor College of Medicine demonstrates a favorable safety profile and up to 84.6% disease control rate in patients with ...

Multi-Antigen Targeted T Cells Yield Promising Efficacy in ...

After at least 1 infusion, the complete response rate was 7.7%, and the partial response rate was 15.4%. Stable disease occurred in 61.5% of ...

Award | SBIR

In vitro studies show that MT-601 was far superior in controlling growth of PANC1 pancreatic cancer cells versus control conditions. More importantly, ...

MT-601 Administered To Patients With Locally Advanced ...

The goal of this clinical trial is to assess safety and tolerability of escalating doses of MT-601 administered during the off week of chemotherapy regimen ...

Rethinking CAR-T for pancreatic cancer

In terms of efficacy, 3 patients achieved partial responses and 14 experienced stable disease, resulting in a 3-month disease control rate of 65.2% and a median ...

FDA Grants Orphan Drug Designation to MT-601 for ...

MT-601 treatment did not result in any infusion-related systemic events or neurotoxicity, and it was determined that the agent is safe and ...

Safety and Preliminary Efficacy of MT-601 in Patients With ...

This study is a Phase 1 multicenter study with a Dose Escalation and Dose Expansion evaluating safety and efficacy of MT-601 administration ...