Clinical Trials Logo

Clinical Trial Summary

This is a data collection study, also referred to as a "screening" study; no investigational or standard therapy will be administered as part of this study. In order to identify subjects for the Phase I/II study, TCR001-201, patients with following histologically confirmed tumor types will be initially screened in this protocol for their somatic mutation and HLA type: - Gynecologic cancer (ovarian or endometrial) - Colorectal cancer - Pancreatic cancer - Non-small cell lung cancer (NSCLC). NSCLC includes but is not limited to squamous cell carcinoma, adenosquamous carcinoma or adenocarcinomas - Cholangiocarcinoma Subjects' somatic mutation(s) and HLA type restriction combination will be examined against Ziopharm Oncology Inc.'s (Ziopharm) TCR library to determine if a TCR match is available for that subject. Subjects without a match will be discontinued from this protocol. Subjects with a TCR match in the Ziopharm TCR library will continue to be followed on this protocol and their clinical status will be monitored on an ongoing basis for eligibility, i.e., for progressive or recurrent disease, to enroll and receive TCR-T cell therapy on the Phase I/II study. Subjects will complete participation on this protocol when the subject enrolls on the Phase I/II study or if the subject dies.


Clinical Trial Description

This protocol will be used to perform and/or collect results from genetic mutation testing (e.g., Oncomineā„¢ or similar genomic test performed at a CLIA-certified laboratory) and high resolution, human leukocyte antigen (HLA) class I and II typing from a CLIA-certified laboratory. This protocol will also collect subject clinical baseline characteristics, demographics, and cancer history. This protocol will be used to monitor subject disease status to identify candidates for enrollment onto the Phase I/II study as patients must have progressive or recurrent disease to be enrolled onto that protocol. The subject's somatic mutation(s) and HLA type restriction combination will be examined against Ziopharm's TCR library to determine if a TCR is available for that subject. Subjects without a TCR match will be discontinued from this protocol. If the subject's somatic mutation and HLA type restriction combination matched TCR is added to the Ziopharm TCR library after the subject discontinues, the investigator may contact the subject to be re-screened for the study. Subjects with a TCR match in the Ziopharm TCR library will continue to be followed on this protocol and their clinical status will be monitored on an ongoing basis for eligibility, particularly progressive or recurrent disease, to enroll and receive TCR-T cell therapy on the Phase I/II study. Clinical status will be collected at enrollment and approximately every 3 months in conjunction with subjects' regularly scheduled standard of care visits. Subjects with a TCR match will complete participation on this protocol once they enroll in the Phase I/II study or if the subject dies. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05124743
Study type Observational
Source Ziopharm
Contact Raffaele Baffa, MD
Phone 1 617-315-1790
Email [email protected]
Status Recruiting
Phase
Start date September 24, 2021
Completion date May 28, 2028

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05043922 - A Study to Evaluate the Efficacy and Safety of CYH33 in Patients With Recurrent/Persistent Ovary Clear Cell Carcinoma Phase 2
Recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Suspended NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer Phase 2
Recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Suspended NCT02432378 - Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines Phase 1/Phase 2
Recruiting NCT04533763 - Living WELL: A Web-Based Program for Ovarian Cancer Survivors N/A
Active, not recruiting NCT03371693 - Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer Phase 3
Withdrawn NCT03032614 - Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients Phase 2
Completed NCT01936363 - Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer Phase 2
Completed NCT02019524 - Phase Ib Trial of Two Folate Binding Protein Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients Phase 1
Active, not recruiting NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Recruiting NCT05059522 - Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing Phase 3
Recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Recruiting NCT04586335 - Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors. Phase 1
Terminated NCT03146663 - NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer Phase 2
Recruiting NCT03010124 - Prognostic and Predictive Biomarkers in Ovarian Cancers N/A
Active, not recruiting NCT00587886 - Estrogen, Diet, Genetics and Endometrial Cancer
Completed NCT03652077 - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Phase 1
Active, not recruiting NCT02891824 - ATALANTE: Atezolizumab vs Placebo Phase III Study in Late Relapse Ovarian Cancer Treated With Chemotherapy+Bevacizumab Phase 3
Completed NCT02928549 - Factors Associated With the Use of a High Volume Cancer Center by Black Women With Ovarian Cancer: A Qualitative Study