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

Primary Purpose

Renal Cell Carcinoma, Urothelial Carcinoma

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Bone Marrow Aspirate

About this trial

This is an interventional other trial for Renal Cell Carcinoma focused on measuring marrow infiltrating lymphocytes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Stephenson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Renal Cell Carcinoma or Urothelial Carcinoma Patients

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04341740

First Posted

April 7, 2020

Last Updated

July 8, 2021

Sponsor

University of Oklahoma

Collaborators

WindMIL Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT04341740

Brief Title

Investigating Marrow Infiltrating Lymphocytes in Renal Cell Carcinoma

Acronym

WindMIL-001

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Terminated

Why Stopped

Study funding was withdrawn.

Study Start Date

July 22, 2020 (Actual)

Primary Completion Date

March 9, 2021 (Actual)

Study Completion Date

April 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Oklahoma

Collaborators

WindMIL Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Cell Carcinoma, Urothelial Carcinoma

Keywords

marrow infiltrating lymphocytes

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Renal Cell Carcinoma or Urothelial Carcinoma Patients

Arm Type

Experimental

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

Bone Marrow Aspirate

Intervention Description

bone marrow aspiration

Primary Outcome Measure Information:

Title

Proportion of subjects with successful isolation and ex-vivo expansion of MILs

Description

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

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Abhishek Tripathi, MD

Organizational Affiliation

University of Oklahoma

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stephenson Cancer Center

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Investigating Marrow Infiltrating Lymphocytes in Renal Cell Carcinoma

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