CART-EGFRvIII + Pembrolizumab in GBM
|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: NCT03726515|
Recruitment Status : Recruiting
First Posted : October 31, 2018
Last Update Posted : April 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Biological: CART-EGFRvIII T cells Biological: Pembrolizumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Study of EGFRvIII-Directed CAR T Cells Combined With PD-1 Inhibition in Patients With Newly Diagnosed, MGMT-Unmethylated Glioblastoma|
|Actual Study Start Date :||March 11, 2019|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2034|
|Experimental: CART-EGFRvIII + Pembrolizumab||
Biological: CART-EGFRvIII T cells
autologous T cells that have been engineered to express an extracellular Humanized single chain antibody (scFv) with specificity for EGFRvIII linked to an intracellular signaling molecule comprised of a tandem signaling domain of the 4-1BB and TCRζ signaling modules.
humanized monoclonal immunoglobulin (Ig) G4 antibody directed against human cell surface receptor PD-1 (programmed death-1 or programmed cell death-1) with potential immune checkpoint inhibitory and antineoplastic activities.
Other Name: Keytruda
- Number of subjects with treatment-related adverse events, using NCI CTCAE v5.0. [ Time Frame: 5 Months ]
- Overall survival Rate [ Time Frame: 15 Years ]Number of days from the date of the first CART-EGFRvIII infusion to the date of death of any cause. The survival function of OS will be calculated by the Kaplan-Meier method.
- Progression-free survival (PFS) [ Time Frame: 15 Years ]The number of days from the date of the first CART-EGFRvIII infusion to the first documented disease progression (based on standard MRI evaluation using the modified RANO criteria) or date of death, whichever occurs first. PFS will be calculated by the Kaplan-Meier method.
- Objective response rate (ORR) [ Time Frame: 15 Years ]The proportion of patients with complete response (CR) or partial response (PR) out of the total number of efficacy evaluable subjects. Exact 90%confidence interval for ORR will be computed.
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): NCT03726515
|Contact: Eileen Maloney, MSN, ACNP-BC||215-662-6264||Eileen.Maloney@uphs.upenn.edu|
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Emerging Med 855-216-0098 PennCancerTrials@emergingmed.com|
|Principal Investigator:||Donald O'Rourke, MD||Abramson Cancer Center of the University of Pennsylvania|