Investigating Marrow Infiltrating Lymphocytes in Renal Cell Carcinoma (WindMIL-001)

Investigating Marrow Infiltrating Lymphocytes as a Source of Adoptive Cellular Therapy in Renal Cell Carcinoma and Urothelial Carcinoma

The purpose of this research is to collect health-related information as well as bone marrow and blood specimens to determine if a new form of treatment for patients with kidney and bladder cancer may be possible.

Study Overview

• Status: Terminated
• Conditions: Renal Cell Carcinoma; Urothelial Carcinoma
• Intervention / Treatment: Procedure: Bone Marrow Aspirate

Detailed Description

This research will collect specimens from the bone marrow and blood to determine if a new treatment for kidney or bladder cancer may be possible. This research study will collect a bone marrow sample as well as a blood sample.

Participation in the research study will last approximately 60 days which includes time to determine if the patient is eligible to participate in the study, perform the research procedures and follow-up with the patient following the research procedures to determine if they are experiencing any side effects. Participation will end approximately 30 days following the bone marrow collection.

The bone marrow and blood samples will be collected from all patients in both cohorts only at a single time point, after they have been enrolled on the study.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Stephenson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥18 years
• Histologically-confirmed, locally advanced unresectable or metastatic RCC (cohort A) or UC (cohort B).
• ECOG performance status of ≤1

• Adequate bone marrow function:

  • Platelet count ≥ 100 × 10^9/L
  • ANC ≥ 1.0 ×10^9/L
  • Lymphocyte count ≥ 0.5 ×10^9/L
• Willingness to undergo bone marrow aspiration (BMA)

Exclusion Criteria:

• Prior hematopoietic stem cell transplantation
• Prior radiation to the pelvic region
• Use of systemic corticosteroids within 28 days of BMA
• History of another primary malignancy that has been diagnosed or required therapy within the past 2 years (except completely resected basal cell and squamous cell skin cancer, curatively treated localized prostate cancer, and completely resected carcinoma in situ of any site).
• Presence of an autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosis) requiring active systemic treatment. If the autoimmune disease has been treated, it must be stable clinically. (Hypothyroidism without evidence of Grave's disease or Hashimoto's thyroiditis is not considered an exclusion criterion.)
• Pregnant females as documented by a serum beta human chorionic gonadotropin (β-hCG) pregnancy test consistent with pregnancy, obtained within 21 days of BMA
• Infection requiring treatment with antibiotics, antifungal, or antiviral agents within 7 days of BMA
• Known diagnosis of HIV or CMV infection or active viral hepatitis
• Administration of hematopoietic growth factor support within 14 days before bone marrow aspiration
• Chemotherapy administration within 28 days of BMA
• Unwilling or unable to comply with the protocol
• Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the Investigator's opinion, could affect the safety of the subject.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Renal Cell Carcinoma or Urothelial Carcinoma Patients; Patients in both cohorts (RCC or UC) will undergo bone marrow aspiration under conscious sedation to withdraw 60 mL bone marrow aspirate and 75 ml of peripheral blood sample.	Procedure: Bone Marrow Aspirate; bone marrow aspiration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects with successful isolation and ex-vivo expansion of MILs	A successful expansion will be greater than or equal to 50% viable and greater than or equal to 50% CD3 positive.	30 days

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Collaborators: WindMIL Therapeutics
• Investigators: Principal Investigator: Abhishek Tripathi, MD, University of Oklahoma

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2020
• Primary Completion (Actual): March 9, 2021
• Study Completion (Actual): April 9, 2021

Study Registration Dates

• First Submitted: April 7, 2020
• First Submitted That Met QC Criteria: April 7, 2020
• First Posted (Actual): April 10, 2020

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: marrow infiltrating lymphocytes
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Carcinoma, Renal Cell; Carcinoma; Carcinoma, Transitional Cell
• Other Study ID Numbers: OI-SCC-WINDMIL-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No