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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
~3 spots leftby May 2025
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