Investigating Marrow Infiltrating Lymphocytes in Renal Cell Carcinoma (WindMIL-001)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04341740|
Recruitment Status : Recruiting
First Posted : April 10, 2020
Last Update Posted : May 15, 2020
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma Urothelial Carcinoma||Procedure: Bone Marrow Biopsy||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Investigating Marrow Infiltrating Lymphocytes as a Source of Adoptive Cellular Therapy in Renal Cell Carcinoma and Urothelial Carcinoma|
|Estimated Study Start Date :||May 2020|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2021|
Experimental: Marrow Infiltrating Lymphocyte Isolation and Expansion
Each patient in both cohorts (RCC or UC) will undergo bone marrow aspiration under conscious sedation to withdraw 60 mL bone marrow aspirate.
Procedure: Bone Marrow Biopsy
bone marrow aspiration
- Proportion of subjects with successful isolation and ex-vivo expansion of MILs [ Time Frame: 30 days ]A successful expansion will be greater than or equal to 50% viable and greater than or equal to 50% CD3 positive.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04341740
|Contact: Lead GU Nurse||1-405-271-8777||SCC-IIT-Office@ouhsc.edu|
|United States, Oklahoma|
|Stephenson Cancer Center||Recruiting|
|Oklahoma City, Oklahoma, United States, 73104|
|Contact: Ingrid Block, APRN 405-271-8777 Ingrid-Block@ouhsc.edu|
|Contact: Lead GU Nurse 1-405-271-8777 SCC-IIT-Office@ouhsc.edu|
|Principal Investigator: Abhishek Tripathi, MD|
|Principal Investigator:||Abhishek Tripathi, MD||University of Oklahoma|