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Dendritic Cell Therapy

CMN-001 for Kidney Cancer

Phase 2
Waitlist Available
Research Sponsored by CoImmune
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, an average of 2 years
Awards & highlights

Study Summary

This trial is testing a new immunotherapy treatment for renal cell carcinoma. The treatment involves taking dendritic cells from the patient, loading them with RNA from the patient's tumor, and then injecting them back into the patient. The treatment is given in combination with other drugs.

Eligible Conditions
  • Kidney Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival
Secondary outcome measures
Monitor treatment emergent adverse events between both arms
Progression free survival
Tumor Response

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Combination ArmExperimental Treatment3 Interventions
CMN-001 dosing (1x10^7 DC/dose) is initiated at Visit 2 during 1st line therapy and through 2nd line therapy. CMN-001 is administered as 1 dose every 3 weeks for 3 doses (Induction phase), followed by maintenance doses, 1 every 4 weeks for 7 doses (Maintenance phase), followed by booster doses, 1 dose every 12 weeks (Booster phase). 1st line therapy, Nivolumab (3mg/kg) + Ipilimumab (1 mg/kg) will be administered at 3 week intervals for 4 administrations starting at visit 1. Followed by Nivolumab (3 mg/kg) administration every 4 weeks until progression. After progression, 2nd line therapy with lenvatinib (18mg/day) + everolimus (5mg/day) until discontinuation criteria are met.
Group II: Standard TreatmentActive Control2 Interventions
1st line therapy, Nivolumab (3mg/kg) + Ipilimumab (1 mg/kg) will be administered at 3 week intervals for 4 administrations starting at visit 1. Followed by Nivolumab (3 mg/kg) administration every 4 weeks until progression. After progression 2nd line therapy with lenvatinib (18mg/day) + everolimus (5mg/day) until discontinuation criteria are met.

Find a Location

Who is running the clinical trial?

CoImmuneLead Sponsor

Media Library

CMN-001 (Dendritic Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04203901 — Phase 2
Kidney Cancer Research Study Groups: Combination Arm, Standard Treatment
Kidney Cancer Clinical Trial 2023: CMN-001 Highlights & Side Effects. Trial Name: NCT04203901 — Phase 2
CMN-001 (Dendritic Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04203901 — Phase 2

Frequently Asked Questions

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

Does this research endeavor have any open slots for new participants?

"According to clinicaltrials.gov, this research project is actively enrolling participants and was originally posted on July 22nd 2020. The study information has been updated as recently as July 28th 2022."

Answered by AI

Are there any additional experiments utilizing CMN-001 currently being conducted?

"Presently, 990 clinical trials are operating to explore CMN-001. Of those active tests, 132 have reached the Phase 3 stage of investigation. While most studies concerning this medication take place in Pittsburgh, Pennsylvania, a total of 50882 sites across the globe house research for it."

Answered by AI

How many centers are actively supervising this research?

"Currently, this medical trial is underway at 9 different clinics located in cities such as Morgantown, Pittsburgh and Tampa. Prospective participants should select the clinic that requires the least travel for their convenience."

Answered by AI

What is the aggregate figure of participants taking part in this experiment?

"120 patients, who meet the established eligibility requirements, are needed to complete this trial. Locations that offer it include West virginia University Cancer Institute in Morgantown and UPMC Hillman Cancer Center of Pittsburgh."

Answered by AI

Has the FDA issued an endorsement of CMN-001?

"CMN-001's safety has been partially established, which is why it earned a score of 2. As this trial is only in Phase 2, there are no findings yet to support its efficacy."

Answered by AI

What medical conditions has CMN-001 been clinically proven to ameliorate?

"CMN-001 is the primary treatment for unresectable melanoma, although it may also be beneficial in treating other cancers such as squamous cell carcinoma, lung cancer and advanced carcinoid tumors."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Dendritic Cell Immunotherapy Plus Standard Treatment of Advanced Renal Cell Carcinoma
2020. "Dendritic Cell Immunotherapy Plus Standard Treatment of Advanced Renal Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04203901.
~3 spots leftby Apr 2025
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