- |||||||||| iC9.GD2.CAR.IL-15 T-cells / UNC Lineberger Comprehensive Cancer Center
Trial completion date, Trial primary completion date: Autologous CAR T-Cells Targeting the GD2 Antigen for Lung Cancer (clinicaltrials.gov) - Mar 4, 2025
P1, N=24, Recruiting,
Trial completion date: Feb 2027 --> Oct 2029 | Trial primary completion date: Feb 2025 --> Nov 2027
- |||||||||| ATLCAR.CD138 / UNC Lineberger Comprehensive Cancer Center
Enrollment closed, Trial completion date, Trial primary completion date: Study of ATLCAR.CD138 Cells for Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - Feb 3, 2025
P1, N=25, Active, not recruiting,
Trial completion date: Feb 2027 --> Oct 2029 | Trial primary completion date: Feb 2025 --> Nov 2027 Recruiting --> Active, not recruiting | Trial completion date: Jun 2030 --> Aug 2039 | Trial primary completion date: Jul 2026 --> Oct 2024
- |||||||||| 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,
Recruiting --> Active, not recruiting | N=21 --> 7 | Trial primary completion date: Feb 2025 --> Feb 2024 Trial completion date: Aug 2040 --> Aug 2038 | Trial primary completion date: Aug 2025 --> Sep 2027
- |||||||||| CAR.B7-H3 T / UNC Lineberger Comprehensive Cancer Center
Enrollment open: Autologous CAR-T Cells Targeting B7-H3 in PDAC (clinicaltrials.gov) - Aug 13, 2024
P1, N=27, Recruiting,
Trial primary completion date: Oct 2024 --> May 2030 Not yet recruiting --> Recruiting
- |||||||||| CAR.B7-H3 T / UNC Lineberger Comprehensive Cancer Center
Trial initiation date: Autologous CAR-T Cells Targeting B7-H3 in PDAC (clinicaltrials.gov) - Jul 17, 2024
P1, N=27, Not yet recruiting,
Not yet recruiting --> Recruiting Initiation date: Jun 2024 --> Sep 2024
- |||||||||| ATLCAR.CD138 / UNC Lineberger Comprehensive Cancer Center
Trial completion date, Trial primary completion date: Study of ATLCAR.CD138 Cells for Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - Jul 11, 2024
P1, N=33, Recruiting,
Initiation date: Jun 2024 --> Sep 2024 Trial completion date: Jun 2028 --> Jun 2030 | Trial primary completion date: Jul 2024 --> Jul 2026
- |||||||||| 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,
Trial completion date: Jun 2028 --> Jun 2030 | Trial primary completion date: Jul 2024 --> Jul 2026 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,
Initiation date: Mar 2024 --> Jul 2024 Trial completion date: Aug 2038 --> Aug 2040 | Trial primary completion date: Aug 2023 --> Aug 2025
- |||||||||| iC9.GD2.CAR.IL-15 T-cells / UNC Lineberger Comprehensive Cancer Center
Enrollment open: Autologous CAR T-Cells Targeting the GD2 Antigen for Lung Cancer (clinicaltrials.gov) - Jul 10, 2023
P1, N=24, Recruiting,
Trial completion date: Aug 2038 --> Aug 2040 | Trial primary completion date: Aug 2023 --> Aug 2025 Not yet recruiting --> Recruiting
- |||||||||| TT11 / Tessa Therap, UNC Lineberger Comprehensive Cancer Center, Baylor Scott & White Research Institute
Trial completion date: CD30 CAR T Cells, Relapsed CD30 Expressing Lymphoma (RELY-30) (clinicaltrials.gov) - Mar 8, 2023
P1, N=60, Recruiting,
Recruiting --> Active, not recruiting 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
- |||||||||| ATLCAR.CD138 / UNC Lineberger Comprehensive Cancer Center
Trial completion date, Trial primary completion date: Study of ATLCAR.CD138 Cells for Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - Jan 11, 2023
P1, N=33, Recruiting,
Trial primary completion date: Aug 2023 --> Feb 2028 Trial completion date: Oct 2032 --> Jun 2028 | Trial primary completion date: Nov 2022 --> Jul 2024
- |||||||||| 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.
- |||||||||| CAR.B7-H3 T / UNC Lineberger Comprehensive Cancer Center
Enrollment open, Trial primary completion date: Autologous CAR-T Cells Targeting B7-H3 in Recurrent or Refractory GBM CAR.B7-H3Tc (clinicaltrials.gov) - Sep 10, 2022
P1, N=36, Recruiting,
The efficacy, safety and exploratory biomarkers of CD30.CAR-T will be further evaluated in the Pivotal segment of this Phase 2 study. Not yet recruiting --> Recruiting | Trial primary completion date: May 2030 --> Oct 2024
- |||||||||| 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.
- |||||||||| 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) - Jul 23, 2022
P1, N=66, Recruiting,
2021 Feb 10;39(5):514-524. 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,
Trial completion date: Sep 2038 --> Jun 2039 | Trial primary completion date: Sep 2023 --> Jun 2024 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
- |||||||||| 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,
Trial primary completion date: Nov 2021 --> Nov 2022 Trial completion date: Aug 2037 --> Aug 2038 | Trial primary completion date: Aug 2022 --> Aug 2023
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