Dendritic Cell Immunotherapy for Kidney Cancer

No longer recruiting at 8 trial locations

Overseen By Mark DeBenedette, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: CoImmune

Must not be taking: Immunosuppressants

Disqualifiers: Brain metastases, Cardiovascular conditions, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 35

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called CMN-001 for advanced kidney cancer (renal cell carcinoma). CMN-001 is an immune therapy that uses a patient's own cells to fight cancer, combined with standard cancer drugs. The trial aims to determine if adding CMN-001 improves treatment outcomes. Individuals with advanced kidney cancer who can begin first-line standard therapy might be suitable candidates for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

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

The trial protocol does not specify if you need to stop your current medications, but it mentions that you must be able to abstain from taking prohibited drugs during the treatment phase. It's best to discuss your specific medications with the trial team.

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

Research has shown that CMN-001, a treatment using the body's immune cells, is generally well-tolerated. Some patients experience mild reactions at the injection site, such as redness, swelling, rash, or tiredness. These side effects are common and usually not serious. Although early studies showed promise, later trials found no additional benefits when combining CMN-001 with sunitinib, another cancer treatment. However, researchers continue to study the treatment's potential benefits and safety when used with other therapies for advanced kidney cancer. ^{1 2 3 4 5}

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

Unlike the standard treatments for advanced renal cell carcinoma, which usually include drugs like Nivolumab and Ipilimumab that target immune checkpoints, CMN-001 introduces a new approach by using dendritic cell immunotherapy. This treatment is unique because it involves personalized immunotherapy, where dendritic cells are engineered to better stimulate the patient's immune system to attack cancer cells. Researchers are excited about CMN-001 because it could potentially enhance the body's natural ability to fight cancer, offering a new avenue for patients who may not respond optimally to current treatments. This innovative mechanism of action may lead to more effective and lasting cancer control.

What evidence suggests that CMN-001 could be an effective treatment for advanced renal cell carcinoma?

Research shows that CMN-001, a treatment using the body's own immune cells, may help treat advanced kidney cancer. In this trial, participants in the Combination Arm will receive CMN-001 alongside standard therapies. This therapy uses the patient's cells to create a strong immune response against the cancer. Early studies have shown that CMN-001 can target and fight cancer cells by using specific markers from the patient's tumor. This method aims to boost the body's natural ability to find and destroy cancer cells more effectively. While more research continues, the results so far are promising for those with advanced kidney cancer. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

Advanced disease histologically assessed as RCC, with predominantly clear cell histology

Adequate renal function, as defined by either of the following criteria:

Adequate hepatic function, as defined by both of the following:

Exclusion Criteria

Pregnancy or breastfeeding

Prior history of malignancy within the preceding 3 years, except for adequately treated in situ carcinomas or non-melanoma skin cancer, adequately treated early stage breast cancer, superficial bladder cancer, and non-metastatic prostate cancer with a normal PSA

You have a history of cancer spreading to the brain or spinal cord, or signs of cancer in the brain or protective covering of the brain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Induction

CMN-001 dosing initiated during 1st line therapy, administered as 1 dose every 3 weeks for 3 doses

9 weeks

3 visits (in-person)

Maintenance

CMN-001 maintenance doses, 1 every 4 weeks for 7 doses

28 weeks

7 visits (in-person)

Booster

CMN-001 booster doses, 1 dose every 12 weeks

Long-term

Every 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Through study completion, an average of 2 years

Every 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CMN-001

How Is the Trial Designed?

Group I: Combination Arm Experimental Treatment 3 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 Treatment Active Control 2 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.

Who Is Running the Clinical Trial?

CoImmune

Lead Sponsor

Trials

1

Recruited

20+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10332239/

A review of the clinical experience with CMN-001, a tumor ... In this review, we focus on the experience with CMN-001, formally AGS-003, a DC-based immunotherapy, employing autologous DC electroporated with autologous ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0753332225000526

The power of dendritic cell-based vaccines in immunotherapy This review offers a comprehensive analysis of the present-day progress in dendritic cell (DC)-based vaccines and recent efforts to enhance their efficacy.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37387210/

A review of the clinical experience with CMN-001, a tumor ... In this review, we focus on the experience with CMN-001, formally AGS-003, a DC-based immunotherapy, employing autologous DC electroporated with autologous ...

4. tandfonline.com tandfonline.com/doi/abs/10.1080/21645515.2023.2220629

A review of the clinical experience with CMN-001, a tumor ... In this review, we focus on the experience with CMN-001, formally AGS-003, a DC-based immunotherapy, employing autologous DC electroporated with autologous ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2405456922000803

Autologous Dendritic Vaccine Therapy in Metastatic Kidney ... CMN-001 is designed to elicit a broad immune response for an individual patient by capturing the known, unknown, and mutated antigens present in a patient's ...

6. mycancergenome.org mycancergenome.org/content/clinical_trials/NCT04203901/

Clinical Trial: NCT04203901 CMN-001 is indicated for treatment of intermediate/poor risk patients with advanced renal cell carcinoma (RCC) in combination with nivolumab plus ipilimumab as ...

7. georgiacancerinfo.org georgiacancerinfo.org/clinical-trials/detail/5197?cancerType=kidney-cancer

Dendritic Cell Immunotherapy Plus Standard Treatment ... Summary. CMN-001 is an autologous, tumor antigen-loaded dendritic cell immunotherapy. The active components of CMN-001 are autologous, matured dendritic ...

8. mayo.edu mayo.edu/research/clinical-trials/diseases-conditions/renal-cell-carcinoma

Renal Cell Carcinoma Clinical Trials The goals of the study are to determine the safety and tolerability of X4P-001, as well as the potential effect it may have on the body and the cancer tumor.