Proof of Concept of TBio-4101, Lymphodepleting Chemo, IL-2 for Relapsed/Refractory Melanoma
|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: NCT05628883|
Recruitment Status : Recruiting
First Posted : November 29, 2022
Last Update Posted : January 26, 2023
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Melanoma Unresectable Melanoma Acral Melanoma Mucosal Melanoma Cutaneous Melanoma Ocular Melanoma Uveal Melanoma Iris Melanoma Conjunctival Melanoma Non-Cutaneous Melanoma||Biological: TBio-4101 Drug: Cyclophosphamide Drug: Fludarabine Drug: Interleukin-2||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Proof of Concept Study of TBio-4101 (an Autologous Selected and Expanded Tumor Infiltrating Lymphocyte [TIL] Therapy) Using Short-Term Cultured, Selected Autologous TIL Following a Lymphodepleting Chemotherapy Regimen and Followed by IL-2 for Patients With Relapsed or Refractory Melanoma (Phase 1)|
|Actual Study Start Date :||November 8, 2022|
|Estimated Primary Completion Date :||January 31, 2024|
|Estimated Study Completion Date :||December 31, 2024|
Experimental: Infusion of TBio-4101 TIL
TBio-4101 is a tumor-infiltrating lymphocyte (TIL) product: participants tumor tissue is surgically removed and immune T-cells are taken out of the tumor and multiplied, or grown, in the laboratory. TIL product infused intravenously over 20 to 30 minutes within 2 to 4 days after the last dose of fludarabine
Participants will also receive:
TBio-4101 is a tumor-infiltrating lymphocyte (TIL) product that involves the use of special immune cells called T-cells. A T-cell is a type of lymphocyte, or white blood cell.
Other Name: Tumor-Infiltrating Lymphocyte
Participants will receive Cyclophosphamide 60 mg/kg/day intravenously (IV) in 250 mL over approximately 1 hour per day for 2 days.
Participants will receive an intravenously (IV) infusion of Fludarabine 25 mg/m2 for approximately 15 to 30 minutes for 5 days, prior to T-Cell infusion
Other Name: Fludara
Participants will receive Interleukin-2 (IL-2) 600 000 IU/kg intravenously every 8 to 12 hours beginning within 24 hours after T-cell infusion.
Other Name: IL-2
- Percentage of Participants that Successfully Receive TBio-4101 [ Time Frame: Day 7 ]Percentage of participants who undergo tumor resection that successfully receive TBio-4101
- Objective Response Rate (OOR) [ Time Frame: 2 years after receiving TIL Transfer ]ORR will be calculated using irRECIST and RECIST v1.1
- 6 Month Overall Survival (OS) [ Time Frame: at 6 Months ]OS is defined as the time from enrollment to death
- 12 Month Overall Survival (OS) [ Time Frame: at 12 Months ]OS is defined as the time from enrollment to death
- 6 Month Progression Free Survival (PFS) [ Time Frame: at 6 Months ]PFS is defined as the time from study enrollment until disease progression or death.
- 12 Month Progression Free Survival (PFS) [ Time Frame: at 12 Months ]PFS is defined as the time from study enrollment until disease progression or death.
- Durable Response Rate (DRR) [ Time Frame: Up to 6 Months after 12 months of Treatment ]DRR is defined as a continuous response, beginning within 12 months of treatment and lasting > 6 months
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): NCT05628883
|Contact: Ali Shrewsbury||813-745-8281||Alexandria.Shrewsbury@moffitt.org|
|United States, Florida|
|Moffitt Cancer Center||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Yvonne Nguyen 813-745-6869 firstname.lastname@example.org|
|Principal Investigator: Amod Sarnaik, MD|
|Sub-Investigator: Veron Sondak, MD|
|Principal Investigator:||Amod Sarnaik, MD||Moffitt Cancer Center|