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WindMIL-001: Investigating Marrow Infiltrating Lymphocytes in Renal Cell Carcinoma

Sponsor
University of Oklahoma (Other)
Overall Status
Terminated
CT.gov ID
NCT04341740
Collaborator
WindMIL Therapeutics (Industry)
6
Enrollment
1
Location
1
Arm
8.6
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Bone Marrow Aspirate
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Patients enrolled on this study in either the Renal Cell Carcinoma cohort or the Urothelial Carcinoma cohort will undergo the same procedures of bone marrow aspiration and blood draw.Patients enrolled on this study in either the Renal Cell Carcinoma cohort or the Urothelial Carcinoma cohort will undergo the same procedures of bone marrow aspiration and blood draw.
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Investigating Marrow Infiltrating Lymphocytes as a Source of Adoptive Cellular Therapy in Renal Cell Carcinoma and Urothelial Carcinoma
Actual Study Start Date :
Jul 22, 2020
Actual Primary Completion Date :
Mar 9, 2021
Actual Study Completion Date :
Apr 9, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Proportion of subjects with successful isolation and ex-vivo expansion of MILs [30 days]

    A successful expansion will be greater than or equal to 50% viable and greater than or equal to 50% CD3 positive.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stephenson Cancer Center Oklahoma City Oklahoma United States 73104

Sponsors and Collaborators

  • University of Oklahoma
  • WindMIL Therapeutics

Investigators

  • Principal Investigator: Abhishek Tripathi, MD, University of Oklahoma

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT04341740
Other Study ID Numbers:
  • OU-SCC-WindMIL-001
First Posted:
Apr 10, 2020
Last Update Posted:
Jul 15, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Oklahoma
marrow infiltrating lymphocytes
Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Carcinoma, Transitional Cell

Study Results

No Results Posted as of Jul 15, 2021