- |||||||||| TT11 / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute
Evaluating the Safety and Clinical Efficacy of Off-the-Shelf CD30.CAR-Modified Epstein-Barr Virus-Specific T Cells in Patients with CD30-Positive Lymphoma (Salt Palace Convention Center Ballroom J) - Dec 3, 2021 - Abstract #TCTASTCTCIBMTR2022TCT_ASTCT_CIBMTR_137; P1 To assess the safety and clinical activity of banked CD30.CAR EBVSTs, we enrolled patients with multiply relapsed (median of 4 prior lines of therapy; range 3-5) or refractory CD30-positive lymphomas in a Phase 1 dose escalation study using 4 × 10 7 , 1 × 10 8 or 4 × 10 8 CD30.CAR EBVSTs infused after cytoreduction with cyclophosphamide and fludarabine...In summary, banked CD30.CAR EBVSTs can safely be given to allogeneic recipients and may cause significant tumor responses including complete remissions. These cells may be a suitable platform for other “off-the-shelf” CAR-T cell therapies.
- |||||||||| CD30.CAR-T cell therapy / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute
Safety and Efficacy Profile of Autologous CD30.CAR-T-Cell Therapy in Patients with Relapsed or Refractory Classical Hodgkin Lymphoma (CHARIOT Trial) (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_5545; CD30 is a validated target for classical Hodgkin Lymphoma (cHL), as demonstrated by the activity of the anti-CD30 antibody drug conjugate, brentuximab vedotin (BV), making it an attractive target for CAR-T therapy in this disease...Eligible patients undergo leukapheresis for manufacture of CD30.CAR-T cells, followed by LD chemotherapy using bendamustine and fludarabine, prior to infusion of CD30.CAR-T with an allowable dose range of 2.0 to 2.7 × 10 8 CD30.CAR-T cells per m 2...Conclusion Preliminary data from the Pilot segment of this study confirms favorable safety profile and excellent anti-tumor responses of CD30.CAR-T in heavily-treated R/R cHL patients. The efficacy and safety of CD30.CAR-T will be further evaluated in the Pivotal segment of this Phase 2 study.
- |||||||||| CD30.CAR-T cell therapy / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute
Safety and Efficacy of Off-the-Shelf CD30.CAR-Modified Epstein-Barr Virus-Specific T Cells in Patients with CD30-Positive Lymphoma (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_3347; P1 To assess the safety and activity of banked CD30.CAR EBVSTs, we treated patients with multiply relapsed (median of 4 prior lines of therapy; range 3-5) or refractory CD30-positive lymphomas in a Phase 1 dose escalation study using 4 × 10 7 , 1 × 10 8 or 4 × 10 8 CD30.CAR EBVSTs infused after lymphodepletion with cyclophosphamide and fludarabine...Thus banked CD30.CAR EBVSTs can safely be given to allogeneic recipients and may cause significant tumor responses including complete remissions. These cells may be a suitable platform for other “off-the-shelf” CAR-T cell therapies.
- |||||||||| ATLCAR.CD30.CCR4 cells / UNC Lineberger Comprehensive Cancer Center, Actemra IV (tocilizumab) / Roche, JW Pharma
CD30-Directed CAR-T Cells Co-Expressing CCR4 in Relapsed/Refractory Hodgkin Lymphoma and CD30+ Cutaneous T Cell Lymphoma (GWCC - A411-A412, Level 4) - Nov 5, 2021 - Abstract #ASH2021ASH_2237; P1 All patients receive lymphodepletion with 3 days of bendamustine 70 mg/m 2 and fludarabine 30 mg/m 2...All patients had received prior brentuximab vedotin...Two patients had grade 2 cytokine release syndrome (CRS) which resolved with tocilizumab, and 1 had self-limiting grade 1 CRS...Interestingly, responses are already seen at the lowest dose level, suggesting that early tumor homing driven by CCR4 may allow more fitted cells to better exploit their antitumor potential. Our data serve as a proof of concept for future modifications of CAR-T cells to improve their localization to disease sites.
- |||||||||| TT11 / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute
Trial completion date, Trial primary completion date: Administration of T Lymphocytes for Prevention of Relapse of Lymphomas (clinicaltrials.gov) - Jul 7, 2021 P1, N=18, Recruiting, Trial completion date: Apr 2031 --> Oct 2032 | Trial primary completion date: Apr 2021 --> Oct 2022 Trial completion date: Sep 2036 --> Jan 2037 | Trial primary completion date: Sep 2021 --> Jan 2022
- |||||||||| ATLCAR.CD138 / UNC Lineberger Comprehensive Cancer Center
Trial primary completion date: Study of ATLCAR.CD138 Cells for Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - Jun 30, 2021 P1, N=33, Recruiting, Trial completion date: Sep 2036 --> Jan 2037 | Trial primary completion date: Sep 2021 --> Jan 2022 Trial primary completion date: Nov 2020 --> Nov 2021
- |||||||||| TT11 / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute
Trial primary completion date: CD30 CAR T Cells, Relapsed CD30 Expressing Lymphoma (RELY-30) (clinicaltrials.gov) - Jun 10, 2021 P1, N=66, Recruiting, Trial primary completion date: Nov 2020 --> Nov 2021 Trial primary completion date: Apr 2021 --> Apr 2022
- |||||||||| TT11 / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute
Trial completion date, Trial initiation date, Trial primary completion date: CERTAIN: Phase 1 Study of Autologous CD30.CAR-T in Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma (clinicaltrials.gov) - Mar 7, 2021 P1, N=21, Recruiting, Trial completion date: Aug 2024 --> Feb 2036 Trial completion date: Feb 2023 --> Mar 2036 | Initiation date: Nov 2020 --> Mar 2021 | Trial primary completion date: Feb 2022 --> Mar 2023
- |||||||||| TT11 / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute
Trial completion date, Trial primary completion date: Study of CD30 CAR for Relapsed/Refractory CD30+ HL and CD30+ NHL (clinicaltrials.gov) - Sep 17, 2020 P1/2, N=40, Recruiting, Initiation date: May 2020 --> Dec 2020 Trial completion date: Feb 2037 --> Aug 2038 | Trial primary completion date: Feb 2022 --> Aug 2023
- |||||||||| TT11 / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute
Trial completion date, Trial primary completion date: CD30 CAR for Relapsed/Refractory CD30+ T Cell Lymphoma (clinicaltrials.gov) - Sep 15, 2020 P2, N=20, Recruiting, Trial completion date: Feb 2037 --> Aug 2038 | Trial primary completion date: Feb 2022 --> Aug 2023 Trial completion date: Sep 2034 --> Aug 2037 | Trial primary completion date: Sep 2021 --> Aug 2022
- |||||||||| TT11 / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute
Trial completion date, Trial primary completion date: Administration of T Lymphocytes for Prevention of Relapse of Lymphomas (clinicaltrials.gov) - May 26, 2020 P1, N=18, Recruiting, Trial completion date: Sep 2034 --> Aug 2037 | Trial primary completion date: Sep 2021 --> Aug 2022 Trial completion date: Sep 2034 --> Sep 2036 | Trial primary completion date: Apr 2020 --> Sep 2021
- |||||||||| TT11 / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute
Enrollment open: Study of CD30 CAR for Relapsed/Refractory CD30+ HL and CD30+ NHL (clinicaltrials.gov) - May 26, 2020 P1/2, N=40, Recruiting, Trial completion date: Sep 2034 --> Sep 2036 | Trial primary completion date: Apr 2020 --> Sep 2021 Active, not recruiting --> Recruiting
- |||||||||| TT11 / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute
Enrollment closed, Trial completion date, Trial primary completion date: Study of CD30 CAR for Relapsed/Refractory CD30+ HL and CD30+ NHL (clinicaltrials.gov) - Jan 9, 2020 P1/2, N=40, Active, not recruiting, Initiation date: Feb 2020 --> Sep 2020 Recruiting --> Active, not recruiting | Trial completion date: Oct 2036 --> Feb 2037 | Trial primary completion date: Oct 2021 --> Feb 2022
- |||||||||| ATLCAR.CD30.CCR4 cells / UNC Lineberger Comprehensive Cancer Center, TT11 / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute
Enrollment change, Trial completion date, Trial primary completion date: LCCC 1606-ATL: Study of CAR-T Cells Expressing CD30 and CCR4 for r/r CD30+ HL and CTCL (clinicaltrials.gov) - Jan 9, 2020 P1, N=59, Recruiting, Recruiting --> Active, not recruiting | Trial completion date: Oct 2036 --> Feb 2037 | Trial primary completion date: Oct 2021 --> Feb 2022 N=36 --> 59 | Trial completion date: May 2036 --> Sep 2041 | Trial primary completion date: May 2021 --> Sep 2026
- |||||||||| TT11 / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute
Trial primary completion date: Administration of T Lymphocytes for Prevention of Relapse of Lymphomas (clinicaltrials.gov) - Oct 24, 2019 P1, N=18, Recruiting, Trial completion date: May 2036 --> Jun 2039 | Trial primary completion date: May 2021 --> Jun 2024 Trial primary completion date: Sep 2019 --> Apr 2020
- |||||||||| TT11 / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute
Enrollment open: CD30 CAR for Relapsed/Refractory CD30+ T Cell Lymphoma (clinicaltrials.gov) - Oct 16, 2019 P2, N=20, Recruiting, Trial primary completion date: Sep 2019 --> Apr 2020 Not yet recruiting --> Recruiting
- |||||||||| TT11 / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute
Enrollment change, Trial completion date, Trial primary completion date: CD30 CAR T Cells, Relapsed CD30 Expressing Lymphoma (RELY-30) (clinicaltrials.gov) - May 29, 2019 P1, N=66, Recruiting, Not yet recruiting --> Recruiting N=18 --> 66 | Trial completion date: Feb 2035 --> Feb 2036 | Trial primary completion date: Apr 2020 --> Apr 2021
- |||||||||| TT11 / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute
New trial: Compassionate Use Re-Infusion of ATLCAR.CD30 (clinicaltrials.gov) - Apr 16, 2019 P, N=0, No Longer Available,
- |||||||||| TT11 / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute
Trial completion date, Trial primary completion date: Study of CD30 CAR for Relapsed/Refractory CD30+ HL and CD30+ NHL (clinicaltrials.gov) - Dec 20, 2018 P1/2, N=40, Recruiting, Not yet recruiting --> Recruiting Trial completion date: Oct 2034 --> Oct 2036 | Trial primary completion date: Oct 2019 --> Oct 2021
- |||||||||| ATLCAR.CD30.CCR4 cells / UNC Lineberger Comprehensive Cancer Center, TT11 / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute
Enrollment open: LCCC 1606-ATL: Study of CAR-T Cells Expressing CD30 and CCR4 for r/r CD30+ HL and CTCL (clinicaltrials.gov) - Sep 28, 2018 P1, N=36, Recruiting, Trial completion date: Oct 2034 --> Oct 2036 | Trial primary completion date: Oct 2019 --> Oct 2021 Not yet recruiting --> Recruiting
- |||||||||| TT11 / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute
Trial primary completion date: Study of CD30 CAR for Relapsed/Refractory CD30+ HL and CD30+ NHL (clinicaltrials.gov) - Sep 13, 2017 P1/2, N=31, Recruiting, Not yet recruiting --> Recruiting Trial primary completion date: May 2019 --> Oct 2019
- |||||||||| TT11 / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute
Trial primary completion date: Administration of T Lymphocytes for Prevention of Relapse of Lymphomas (clinicaltrials.gov) - Sep 13, 2017 P1, N=18, Recruiting, Trial primary completion date: May 2019 --> Oct 2019 Trial primary completion date: Apr 2019 --> Aug 2019
- |||||||||| TT11 / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute
Enrollment open: CD30 CAR T Cells, Relapsed CD30 Expressing Lymphoma (RELY-30) (clinicaltrials.gov) - Jun 14, 2017 P1, N=18, Recruiting, Trial primary completion date: Apr 2019 --> Aug 2019 Not yet recruiting --> Recruiting
- |||||||||| TT11 / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute
Enrollment change: CD30 CAR T Cells, Relapsed CD30 Expressing Lymphoma (RELY-30) (clinicaltrials.gov) - Apr 12, 2017 P1, N=18, Not yet recruiting, Not yet recruiting --> Recruiting N=14 --> 18
- |||||||||| TT11 / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute
Trial initiation date, Trial primary completion date: CD30 CAR T Cells, Relapsed CD30 Expressing Lymphoma (RELY-30) (clinicaltrials.gov) - Jan 8, 2017 P1, N=14, Not yet recruiting, N=14 --> 18 Initiation date: Nov 2016 --> Feb 2017 | Trial primary completion date: Jan 2020 --> Apr 2020
- |||||||||| TT11 / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute
Enrollment open: Study of CD30 CAR for Relapsed/Refractory CD30+ HL and CD30+ NHL (clinicaltrials.gov) - May 6, 2016 P1/2, N=31, Recruiting, Initiation date: Nov 2016 --> Feb 2017 | Trial primary completion date: Jan 2020 --> Apr 2020 Not yet recruiting --> Recruiting
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