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PD-1 Inhibitor

Hemopurifier for Squamous Cell Carcinoma

N/A

Waitlist Available

Led By Dan Zandberg, MD

Research Sponsored by Aethlon Medical Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion - up to two years after entry on protocol or until disease progression

Awards & highlights

Study Summary

This trial is testing whether the Hemopurifier can help the immunosuppressive exosomes in combination with pembrolizumab (Keytruda) in the front line setting, in patients with advanced and/or metastatic squamous cell carcinoma of the head and neck.

Eligible Conditions

Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion - up to two years or until disease progression

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion - up to two years or until disease progression

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion - up to two years or until disease progression for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Events

Safety as measured by adverse events

Secondary outcome measures

Levels of exosomes

Survival

Tumor response

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

1Treatment groups

Experimental Treatment

Group I: Hemopurifier and PembrolizumabExperimental Treatment2 Interventions

In this clinical trial, the exosome-depleting device, the Hemopurifier, will be combined with standard of care therapy, Pembrolizumab. The purpose of the combination is to more effectively reduce immune suppression and provide a combined benefit of immune restoration for patients with recurrent/metastatic HNSCC. Therapy with the Hemopurifier will be initiated on the same day as and prior to Pembrolizumab infusion. The Hemopurifier treatment will be 4h. The subject treated with the Hemopurifier will remain in the Hemopurifier treatment area for the duration of the treatment. Pembrolizumab infusion will take place shortly after Hemopurifier treatment and may take place through the next day if needed.

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Who is running the clinical trial?

Aethlon Medical Inc.Lead Sponsor

2 Previous Clinical Trials

9 Total Patients Enrolled

Dan Zandberg, MDPrincipal InvestigatorUPMC Hillman Cancer Center

2 Previous Clinical Trials

131 Total Patients Enrolled

Steven P. LaRosa, M.D.Study DirectorAethlon Medical Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are participating in this research endeavor?

"Indeed, according to clinicaltrials.gov, this research is actively searching for participants. The trial was initially released on October 22nd 2020 and the latest edit occurred on October 29th 2020. This initiative requires 12 individuals from a single site."

Answered by AI

What medical conditions are treated through the use of Hemopurifier?

"Hemopurifier is usually used to manage malignant tumours. However, it has also shown promise in treating many other conditions such as microsatellite instability high, unresectable melanoma, and cancer progression after chemotherapy treatments."

Answered by AI

Is enrollment still open for this clinical experiment?

"Affirmative. Clinicaltrials.gov displays that this clinical research, which was initially published on October 22nd 2020, is actively recruiting participants at the time of writing. 12 volunteers are required from 1 medical centre to complete the trial successfully."

Answered by AI

Has Hemopurifier been used in any prior investigations?

"Currently, 962 clinical trials are actively researching the potential of Hemopurifier with 122 trials in their final stage. These investigations are being conducted across 35,769 sites with a particular concentration in Houston, Texas."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Hemopurifier Plus Pembrolizumab in Head and Neck Cancer

2020. "Hemopurifier Plus Pembrolizumab in Head and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04453046.