TAC T-cells for the Treatment of HER2-positive Solid Tumors (TACTIC-2)
|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: NCT04727151|
Recruitment Status : Recruiting
First Posted : January 27, 2021
Last Update Posted : December 3, 2021
TAC01-HER2 is a novel cell therapy that consists of genetically engineered autologous T cells expressing T-cell Antigen Coupler (TAC) that recognizes human epidermal growth factor receptor 2 (HER2). TAC directs T-cells to the targeted antigen (HER2), and once engaged with the target, activates them via the endogenous T cell receptor.
This is an open-label, multicenter Phase 1/2 study that aims to establish safety, Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (RP2D), pharmacokinetic profile and efficacy of TAC01-HER2 in subjects with relapsed or refractory solid tumors.
|Condition or disease||Intervention/treatment||Phase|
|HER2-Positive Solid Tumors||Biological: TAC01-HER2||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Trial Investigating Safety and Efficacy of Autologous TAC T Cells Targeting HER2 in Relapsed or Refractory Solid Tumors|
|Actual Study Start Date :||April 19, 2021|
|Estimated Primary Completion Date :||November 2024|
|Estimated Study Completion Date :||February 2025|
Lymphodepletion followed by TAC01-HER2 as a single IV infusion.
TAC01-HER2, fludarabine, cyclophosphamide.
- Incidence of Treatment-Emergent Adverse Events [ Time Frame: 24 Months ]Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5 and American Society for Transplantation and Cellular Therapy (ASTCT) 2018 criteria.
- Determine MTD or RP2D [ Time Frame: 28-42 Days Post-Treatment ]Assessed by incidence of Dose-Limiting Toxicities.
- Determine expansion of TAC01-HER2 [ Time Frame: 24 Months ]Assessed by vector copy number.
- Determine persistence of TAC01-HER2 [ Time Frame: 24 Months ]Assessed by vector copy number.
- Evaluate Overall Response Rate (ORR) [ Time Frame: 1, 3, 6, 9, 12, 18 and 24 months ]Assessed by imaging using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
- Evaluate Overall Survival (OS) [ Time Frame: 24 Months ]Defined as the time between the date of TAC01-HER2 infusion and death due to any cause.
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): NCT04727151
|Contact: Nathan Ternus||(512) email@example.com|
|United States, Illinois|
|University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Brooke Pieke, MS 773-834-9636 firstname.lastname@example.org|
|Contact: Andrea Fadel, BSN, RN 773-702-4779 email@example.com|
|United States, Massachusetts|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Riemke Bouvier 617-582-8529 Riemke_Bouvier@dfci.harvard.edu|
|United States, Texas|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Ecaterina Dumbrava, MD 713-792-3934 firstname.lastname@example.org|
|Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M5G 2C1|
|Contact: Samuel Saibil, MD 416-946-4501 ext 4831 Sam.Saibil@uhn.ca|