- |||||||||| 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) - Oct 29, 2024
P1/2, N=40, Recruiting,
Trial completion date: Aug 2040 --> Aug 2038 | Trial primary completion date: Aug 2025 --> Sep 2027
- |||||||||| ATLCAR.CD30.CCR4 cells / UNC Lineberger Comprehensive Cancer Center, TT11 / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute
Enrollment open, IO biomarker: ATLCAR.CD30.CCR4 for CD30+ HL ATLCAR.CD30.CCR4 Cells (clinicaltrials.gov) - Jun 21, 2024
P1/2, N=31, Recruiting,
This is the largest adoptive T cell therapy trial reported in solid tumors to date. Not yet recruiting --> Recruiting
- |||||||||| ATLCAR.CD30.CCR4 cells / UNC Lineberger Comprehensive Cancer Center, TT11 / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute
New P1/2 trial, IO biomarker: ATLCAR.CD30.CCR4 for CD30+ HL ATLCAR.CD30.CCR4 Cells (clinicaltrials.gov) - Oct 19, 2023
P1/2, N=31, Not yet recruiting,
- |||||||||| 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) - Jul 10, 2023
P1/2, N=40, Recruiting,
N=18 --> 0 | Not yet recruiting --> Withdrawn Trial completion date: Aug 2038 --> Aug 2040 | Trial primary completion date: Aug 2023 --> Aug 2025
- |||||||||| TT11 / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute
Enrollment closed, Combination therapy, Checkpoint inhibition: ACTION: Autologous CD30.CAR-T in Combination With Nivolumab in cHL Patients After Failure of Frontline Therapy (clinicaltrials.gov) - Apr 3, 2023
P1b, N=15, Active, not recruiting,
Trial primary completion date: Mar 2023 --> Nov 2022 Recruiting --> Active, not recruiting
- |||||||||| TT11 / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute, NN1213 / Novo Nordisk
Trial completion date, CAR T-Cell Therapy: CD30 CAR T Cells, Relapsed CD30 Expressing Lymphoma (RELY-30) (clinicaltrials.gov) - Mar 8, 2023
P1, N=60, Recruiting,
Trial completion date: Jun 2038 --> Jun 2040 | Trial primary completion date: Jun 2023 --> Jun 2025 Trial completion date: Feb 2036 --> Feb 2040
- |||||||||| TT11 / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute
Trial primary completion date: CD30 CAR for Relapsed/Refractory CD30+ T Cell Lymphoma (clinicaltrials.gov) - Feb 23, 2023
P2, N=20, Recruiting,
Trial completion date: Feb 2036 --> Feb 2040 Trial primary completion date: Aug 2023 --> Feb 2028
- |||||||||| TT11 / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute
Longitudinal Dynamics of Clonal Hematopoiesis in Patients Receiving Anti-CD30 CAR T-Cell Therapy (World Center Marriott Royal; In-Person) - Dec 16, 2022 - Abstract #TCTASTCTCIBMTR2023TCT_ASTCT_CIBMTR_1285;
P1
The recurrence of DNMT3A and PPM1D mutations indicates the selective influence of prior chemotherapeutics. Given the increasing number of patients receiving CAR-T therapy, further work must determine if high CH prevalence in this cohort is predictive of increased long-term complications in survivors.
- |||||||||| TT11 / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute
Enrollment open: CD30 CAR for CD30+ NSGCT (clinicaltrials.gov) - Dec 16, 2022
P2, N=18, Recruiting,
Given the increasing number of patients receiving CAR-T therapy, further work must determine if high CH prevalence in this cohort is predictive of increased long-term complications in survivors. Not yet recruiting --> Recruiting
- |||||||||| TT11 / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute
New P2 trial: CD30 CAR for CD30+ NSGCT (clinicaltrials.gov) - Dec 2, 2022
P2, N=18, Not yet recruiting,
- |||||||||| TT11 / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute, Opdivo (nivolumab) / Ono Pharma, BMS
Phase 1b/2 Study of Autologous CD30.CAR-T Cells in Combination with Nivolumab in Patients with Relapsed or Refractory Classical Hodgkin Lymphoma after Failure of Frontline Therapy (ACTION) () - Nov 29, 2022 - Abstract #ASH2022ASH_7795;
P1, P1/2,
PD-1 checkpoint inhibitors, in combination with CD30-directed antibody therapy (brentuximab vedotin) or other chemotherapies, have also shown high efficacy in this setting (Advani et al., 2021; Mei et al., 2022; Moskowitz et al., 2021)...Following a leukapheresis procedure for manufacture of CD30.CAR-T cells, patients will be treated with 4 cycles of nivolumab every 4 weeks (Q4W), and a single infusion of CD30.CAR-T cells (given between nivolumab Cycles 2 and 3, and after lymphodepletion with bendamustine and fludarabine)...The key secondary objective is to evaluate potential anti-tumor activity, as assessed by the CR rate of autologous CD30.CAR-T in combination with nivolumab at EOT in 14 evaluable patients, as per Lugano Classification Revised Response System for malignant lymphoma (Cheson et al., 2014). Other secondary objectives are to assess the overall response rate (ORR), duration of response (DOR), and progression-free survival (PFS) of patients in the ASCT and non-ASCT groups.This study is ongoing and one patient has been enrolled to date.
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), TT11 / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute, Opdivo (nivolumab) / Ono Pharma, BMS
Clinical Activity of Anti-PD-1 Therapy Following CD30 CAR-T Cell Therapy in Relapsed Hodgkin Lymphoma () - Nov 29, 2022 - Abstract #ASH2022ASH_7793;
P1, P1/2
The anti-PD-1 antibodies nivolumab and pembrolizumab have both been studied in phase II studies in patients with r/r cHL with ORR ranging between 65-87% and median progression free survival (PFS) ranging from 13-15 months...This study is the first to describe CD30.CAR-T expansion following anti-PD-1 therapy. While further analysis is warranted to assess for CD30.CAR-T functionality after anti-PD-1 exposure, our data suggest that anti-PD-1 therapy may rescue CD30.CAR T cells, supporting further investigations in patients with cHL.
- |||||||||| Adcetris (brentuximab vedotin) / Seagen, Takeda
Updated Results and Correlative Analysis: Autologous CD30.CAR-T-Cell Therapy in Patients with Relapsed or Refractory Classical Hodgkin Lymphoma (CHARIOT Trial) (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_4719;
Methods This is a Phase 2 single arm, multi-center study, enrolling patients (12-75 years) with cHL progression after at least 3 lines of therapy, including chemotherapy, brentuximab vedotin, and anti-programmed cell death (PD)-1 antibodies...The patients were treated with CD30.CAR-T cells, after lymphodepletion chemotherapy using bendamustine and fludarabine, with an allowable dose range of 2.0 to 2.7 × 108 CD30.CAR-T cells per m2...The CD30.CAR-T cells showed good expansion and persistence after infusion. The efficacy, safety and exploratory biomarkers of CD30.CAR-T will be further evaluated in the Pivotal segment of this Phase 2 study.
- |||||||||| rovaleucel (TT10) / Tessa Therap
Trial completion, Trial completion date, Trial primary completion date, Metastases: A Phase III Trial Evaluating Chemotherapy and Immunotherapy for Advanced Nasopharyngeal Carcinoma (NPC) Patients (clinicaltrials.gov) - Oct 20, 2022
P3, N=330, Completed,
The efficacy, safety and exploratory biomarkers of CD30.CAR-T will be further evaluated in the Pivotal segment of this Phase 2 study. Active, not recruiting --> Completed | Trial completion date: Jan 2023 --> Feb 2022 | Trial primary completion date: Jan 2023 --> Feb 2022
- |||||||||| TT11 / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute, Adcetris (brentuximab vedotin) / Seagen, Takeda
CAR T-Cell Therapy in Hodgkin Lymphoma (Level 3, Room 337 AB) - Jul 26, 2022 - Abstract #SOHO2022SOHO_11;
P1
Material and Methods To assess the safety and activity of banked CD30 CAR EBVSTs, we are treating patients with multiply relapsed or refractory CD30-positive lymphomas in a phase 1 dose escalation study using 4×107, 1×108 or 4×108 CD30.CAR EBVSTs infused after lymphodepletion with cyclophosphamide and fl udarabine...Patients had received a median of 5 prior therapies, including potentially high dose chemotherapy with autologous stem cell rescue, checkpoint inhibitors and brentuximab vedotin, and all had active disease at time of CAR-T cell infusion...J Clin Oncol. 2021 Feb 10;39(5):514-524.
- |||||||||| TT11X / Tessa Therap
Trial primary completion date, Virus specific T cells: Allogeneic CD30.CAR-EBVSTs in Patients With Relapsed or Refractory CD30-Positive Lymphomas (clinicaltrials.gov) - Jul 23, 2022
P1, N=18, Recruiting,
Conclusions EBV-CTL as first-line treatment in patients with R/M NPC had a favorable safety profile but did not demonstrate a longer OS vs standard of care (SOC) chemotherapy. Trial primary completion date: Jun 2022 --> Jun 2025
- |||||||||| TT11 / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute, NN1213 / Novo Nordisk
Trial primary completion date, CAR T-Cell Therapy: CD30 CAR T Cells, Relapsed CD30 Expressing Lymphoma (RELY-30) (clinicaltrials.gov) - Jul 23, 2022
P1, N=66, Recruiting,
Trial primary completion date: Jun 2022 --> Jun 2025 Trial primary completion date: Apr 2022 --> Apr 2026
- |||||||||| TT11 / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute
Enrollment closed, Trial completion date, Trial primary completion date, CAR T-Cell Therapy: Phase 2 Study Evaluating Autologous CD30.CAR-T Cells in Patients With Relapsed/Refractory Hodgkin Lymphoma (CHARIOT) (clinicaltrials.gov) - Apr 5, 2022
P2, N=97, Active, not recruiting,
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting | Trial completion date: Feb 2036 --> Mar 2037 | Trial primary completion date: Feb 2023 --> May 2025
- |||||||||| TT11 / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute
Enrollment closed: Administration of T Lymphocytes for Prevention of Relapse of Lymphomas (clinicaltrials.gov) - Feb 24, 2022
P1, N=18, Active, not recruiting,
Recruiting --> Active, not recruiting | Trial completion date: Feb 2036 --> Mar 2037 | Trial primary completion date: Feb 2023 --> May 2025 Recruiting --> Active, not recruiting
- |||||||||| TT12 / Tessa Therap, Opdivo (nivolumab) / BMS, NN1213 / Novo Nordisk
Enrollment closed, Trial primary completion date: HPV-16/18 E6/E7-Specific T Lymphocytes, Relapsed HPV-Associated Cancers, HESTIA (clinicaltrials.gov) - Jan 11, 2022
P1, N=32, Active, not recruiting,
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting | Trial primary completion date: Oct 2021 --> Oct 2022
- |||||||||| 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) - Dec 21, 2021
P2, N=20, Recruiting,
Recruiting --> Active, not recruiting | Trial primary completion date: Oct 2021 --> Oct 2022 Trial completion date: Aug 2037 --> Aug 2038 | Trial primary completion date: Aug 2022 --> Aug 2023
- |||||||||| 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.
- |||||||||| 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,
These cells may be a suitable platform for other “off-the-shelf” CAR-T cell therapies. Trial completion date: Sep 2036 --> Jan 2037 | Trial primary completion date: Sep 2021 --> Jan 2022
- |||||||||| TT11 / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute, NN1213 / Novo Nordisk
Trial primary completion date, CAR T-Cell Therapy: CD30 CAR T Cells, Relapsed CD30 Expressing Lymphoma (RELY-30) (clinicaltrials.gov) - Jun 10, 2021
P1, N=66, Recruiting,
Trial completion date: Sep 2036 --> Jan 2037 | Trial primary completion date: Sep 2021 --> Jan 2022 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 primary completion date: Feb 2021 --> Jan 2023 Trial completion date: Feb 2023 --> Mar 2036 | Initiation date: Nov 2020 --> Mar 2021 | Trial primary completion date: Feb 2022 --> Mar 2023
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