17 Participants Needed

Cell Therapy for Kidney Cancer

KE
KG
Overseen ByKristen Gunn E Wood, R.N.
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Must be taking: Antiangiogenics, Immune-checkpoint inhibitors
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?

Background:Gene transfer is a new cancer therapy takes white blood cells from a person and grows them in a lab. The cells are changed with a virus to attack tumor cells, then returned to the person. Researchers want to see if this therapy fights kidney cancer cells.Objective:To see if gene transfer is safe and causes tumors to shrink.Eligibility:People at least 18 years old with certain kidney cancerDesign:Participants will be screened with blood and urine tests. They may have:* Scans* Heart, lung, and eye tests* Lab tests* Tumor samples takenParticipants will have leukapheresis. Blood will be removed by a needle in an arm. It will go through a machine that removes white blood cells. Plasma and red cells will be returned through a needle in the participant s other arm.Participants cells will be grown in the lab and genetically changed.Participants will stay in the hospital 2-3 weeks. There they will:* Get 2 chemotherapy drugs by catheter (thin plastic tube) inserted into a vein in the chest.* Get the changed cells via catheter.* Get a drug to increase white blood cell count and one to make the cells active.* Recover for about a week.* Have lab and blood tests.After leaving the hospital, participants will:* Take an antibiotic for several months.* Have leukapheresis.* Have one- or two-day clinic visits every few weeks for 2 years, and then as determined by their doctor. These will include blood and lab tests, imaging studies, and physical exam.Participants will have follow-up checks for up to 15 years.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot have had certain cancer treatments like anti-VEGFR therapy or mTOR inhibitors for at least 7 days before the T-cell infusion, and PD-1/PD-L1 or CTLA-4 inhibitors for 4 weeks before the infusion.

Is cell therapy for kidney cancer safe for humans?

Some studies on immunotherapy, which includes cell therapies, show that kidney damage is a rare side effect. It's important to collect more safety data during clinical trials to better understand the risks.12345

How does the Cell Infusion treatment for kidney cancer differ from other treatments?

Cell Infusion for kidney cancer is unique because it involves using the patient's own immune cells, specifically tumor-infiltrating lymphocytes (TIL), which are cultivated and activated outside the body before being infused back into the patient. This approach aims to harness the body's immune system to target and destroy cancer cells, offering a novel alternative to traditional treatments like surgery, chemotherapy, and radiation, which are often less effective for this condition.678910

What data supports the effectiveness of the treatment Cell Infusion for kidney cancer?

Research shows that similar cell-based treatments, like allogeneic stem cell transplantation and dendritic cell/tumor fusions, have led to tumor shrinkage and disease stabilization in some kidney cancer patients, indicating potential effectiveness of cell infusion therapies.311121314

Who Is on the Research Team?

RW

Richard W Childs, M.D.

Principal Investigator

National Heart, Lung, and Blood Institute (NHLBI)

Are You a Good Fit for This Trial?

Adults aged 18-75 with certain types of kidney cancer, who have tried at least one antiangiogenic drug and an immune-checkpoint inhibitor. They must not be HIV or hepatitis positive, have a life expectancy over 3 months, agree to use contraception, and have someone to care for them during the first month post-treatment.

Inclusion Criteria

I have been treated with drugs that target blood vessel growth and immune system checkpoints, unless I couldn't for health, availability, or personal reasons.
Patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, the duration of study participation and 180 days (female patients) or 90 days (male patients) after the end of the treatment if sexually active and able to bear or beget children. In addition, male patients must refrain from sperm donation for 90 days after the final dose of investigational product. Female patients must refrain from egg cell donation for 180 days after the final dose of investigational product.
I have someone who can stay with me during the first month of my treatment.
See 12 more

Exclusion Criteria

I have had a severe reaction to immunotherapy that needed long-term treatment, but not for vitiligo or hypothyroidism.
I have clear cell RCC and no other cancer needing treatment in the last 4 years, except for certain skin, cervical, or breast cancers.
I can understand the study details and can give informed consent, or I have someone who can do it on my behalf.
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by an infusion of HERV-E TCR transduced CD8+/CD34+ enriched T-cells and IL-2 administration

2-3 weeks
Inpatient stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, with clinic visits every few weeks for 2 years, and then as determined by their doctor

Up to 15 years
One- or two-day clinic visits every few weeks

Long-term follow-up

Participants will have follow-up checks for up to 15 years to monitor long-term safety and effectiveness

Up to 15 years

What Are the Treatments Tested in This Trial?

Interventions

  • Cell Infusion
Trial Overview The trial is testing gene transfer therapy where patients' white blood cells are modified in a lab to fight kidney cancer. This involves leukapheresis (blood filtration), chemotherapy drugs, cell modification, reinfusion of changed cells into the patient's body, and follow-up visits for up to 15 years.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: Level 4 is 5 x 10^7 HERV-E TCR transduced CD8+/CD34+ enriched T-cells per kg body weightExperimental Treatment1 Intervention
Participants with Metastatic Clear Cell Renal Cell Carcinoma will receive a lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by an infusion of 5 x 10\^7 HERV-E TCR transduced CD8+/CD34+ enriched T-cells per kg body weight. Following infusion of HERV-E T-cells, participants will receive IL-2 (aldesleukin) which will be administered intravenously twice a day for 14 doses.
Group II: Level 3 is 1 x 10^7 HERV-E TCR transduced CD8+/CD34+ enriched T-cells per kg body weightExperimental Treatment1 Intervention
Participants with Metastatic Clear Cell Renal Cell Carcinoma will receive a lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by an infusion of 1 x 10\^7 HERV-E TCR transduced CD8+/CD34+ enriched T-cells per kg body weight. Following infusion of HERV-E T-cells, participants will receive IL-2 (aldesleukin) which will be administered intravenously twice a day for 14 doses.
Group III: Level 2 is 5 x 10^6 HERV-E TCR transduced CD8+/CD34+ enriched T-cells per kg body weightExperimental Treatment1 Intervention
Participants with Metastatic Clear Cell Renal Cell Carcinoma will receive a lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by an infusion of 5 x 10\^6 HERV-E TCR transduced CD8+/CD34+ enriched T-cells per kg body weight. Following infusion of HERV-E T-cells, participants will receive IL-2 (aldesleukin) which will be administered intravenously twice a day for 14 doses.
Group IV: Level 1 is 1 x 10^6 HERV-E TCR transduced CD8+/CD34+ enriched T-cells per kg body weightExperimental Treatment1 Intervention
Participants with Metastatic Clear Cell Renal Cell Carcinoma will receive a lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by an infusion of 1 x 10\^6 HERV-E TCR transduced CD8+/CD34+ enriched T-cells per kg body weight. Following infusion of HERV-E T-cells, participants will receive IL-2 (aldesleukin) which will be administered intravenously twice a day for 14 doses.

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Heart, Lung, and Blood Institute (NHLBI)

Lead Sponsor

Trials
3,987
Recruited
47,860,000+

Loyola University Medical Center (LUMC)

Collaborator

Trials
1
Recruited
20+

Published Research Related to This Trial

The study demonstrated the feasibility and safety of using ex vivo-expanded NK-92 cells as an allogeneic immunotherapy in 12 patients with refractory renal cell cancer and melanoma, with mild and transient toxicities observed during treatment.
One patient with renal cell cancer survived for 4 years post-infusion, indicating potential long-term benefits, while responses varied among other patients, highlighting the need for further research into this NK-cell based therapy.
Infusion of the allogeneic cell line NK-92 in patients with advanced renal cell cancer or melanoma: a phase I trial.Arai, S., Meagher, R., Swearingen, M., et al.[2022]
Immunotherapy using tumor-infiltrating lymphocytes (TIL) shows promise as a new treatment for kidney cancer metastases, which are difficult to treat with traditional methods like surgery and chemotherapy.
In early clinical trials, activated lymphocytes, cultivated with Interleukin 2 to enhance their cancer-fighting abilities, have demonstrated encouraging results, indicating a potential breakthrough in cancer treatment.
[A new therapeutic concept in the treatment of metastatic cancers of the kidney: the TIL (tumor infiltrating lymphocytes)].Peyret, C.[2006]
Cellular therapy for renal cell carcinoma should be integrated with immunotherapy strategies due to the cancer's known sensitivity to such treatments.
While initial cellular therapies focused on Lymphokine Activated Killer (LAK) cells and Tumor Infiltrating Lymphocytes (TIL), current major evaluations are centered on dendritic cells and allogeneic blood stem cell transplantation.
[Cell therapy in renal cell carcinoma].Ravaud, A.[2009]

Citations

Autologous and allogenic hybrid cell vaccine in patients with metastatic renal cell carcinoma. [2019]
Infusion of the allogeneic cell line NK-92 in patients with advanced renal cell cancer or melanoma: a phase I trial. [2022]
Allogeneic stem cell transplantation for patients with metastatic renal cell carcinoma. [2007]
Immunotherapy for renal cell cancer. [2006]
Phase I/II study of vaccination with electrofused allogeneic dendritic cells/autologous tumor-derived cells in patients with stage IV renal cell carcinoma. [2010]
Single and combination immunotherapy with chemotherapy and the risk of AKI in patients with solid cancer. [2023]
Adverse Renal Effects of Anticancer Immunotherapy: A Review. [2022]
Immunotherapy of metastatic renal cell carcinoma with tumor lysate-pulsed autologous dendritic cells. [2023]
Acute kidney injury associated with immune checkpoint inhibitors: A pharmacovigilance study. [2022]
[A new therapeutic concept in the treatment of metastatic cancers of the kidney: the TIL (tumor infiltrating lymphocytes)]. [2006]
[Immune anticancer response: recent advances in the treatment of renal cell carcinoma]. [2007]
12.United Statespubmed.ncbi.nlm.nih.gov
Feasibility of the adoptive transfusion of allogenic human leukocyte antigen-matched natural killer cells in patients with renal cell carcinoma. [2021]
[Cell therapy for renal cell carcinoma]. [2012]
[Cell therapy in renal cell carcinoma]. [2009]
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