ATLCAR.CD30.CCR4 for CD30+ HL ATLCAR.CD30.CCR4 Cells

Status Recruiting

Clinical Trial Summary

Despite the progress in the therapy, Hodgkin's Lymphoma (HL) remains fatal for more than 15% of patients. Even in patients who are cured, the morbidity of therapy is substantial and long-lasting. New therapeutic agents are required therefore not only to further reduce mortality but also to alleviate morbidity. The majority of HL express the CD30 antigens. CD30 expression is routinely used for the diagnosis of HL. Preclinical observations support CD30 as a viable target of CAR-T therapy. This phase Ib/II study was conducted based on these observations. The purpose of this study is to determine the tolerability of ATLCAR.CD30.CCR4 cells in subjects with Hodgkin's Lymphoma and identify a recommended dose for further. This is a single-center, open-label phase Ib/II trial that uses a 3+3 design to identify a recommended phase 2 dose (RP2D) of ATLCAR.CD30.CCR4 cells in Hodgkin's Lymphoma. The phase II portion is designed to determine the PFS of ATLCAR.CD30.CCR4 in Hodgkin's Lymphoma. Subjects will be enrolled on 1 of 3 dose levels as determined by a 3+3 design. Up to 25 evaluable subjects may then be enrolled in the phase II portion of the study. Subjects may have cells procured to manufacture the ATLCAR.CD30.CCR4 cells if they meet eligibility for procurement. During the time period necessary to manufacture the ATLCAR.CD30.CCR4 cells, Subjects will be allowed to receive standard-of-care bridging therapy at the discretion of their local oncologist. Prior to cell infusion, subjects will undergo additional eligibility evaluations, and then if eligible, will undergo lymphodepletion followed by cell infusion 2-14 days later. Subjects will then be followed for 15 years as is required for studies involving gene transfer experiments.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06090864
Study type	Interventional
Source	UNC Lineberger Comprehensive Cancer Center
Contact	Catherine Cheng
Phone	+1 919-445-4208
Email	UNCImmunotherapy@med.unc.edu
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	April 25, 2024
Completion date	July 1, 2031

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05400122` - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer	Phase 1
Completed	`NCT01947140` - Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies	Phase 1/Phase 2
Recruiting	`NCT05019976` - Radiation Dose Study for Relapsed/Refractory Hodgkin/Non-Hodgkin Lymphoma	N/A
Active, not recruiting	`NCT03617666` - Avelumab in the Frontline Treatment of Advanced Classical Hodgkin Lymphoma - a Window Study	Phase 2
Completed	`NCT04666025` - SARS-CoV-2 Donor-Recipient Immunity Transfer
Recruiting	`NCT02507479` - Thiotepa-based Conditioning for Allogeneic Stem-cell Transplantation (SCT) in Lymphoid Malignancies	Phase 2
Active, not recruiting	`NCT02191930` - Brentuximab Vedotin or B-CAP in the Treatment of Older Patients With Newly Diagnosed Classical Hodgkin Lymphoma	Phase 2
Completed	`NCT01943682` - Safety Study of CPX-351 in Children With Relapsed Leukemia or Lymphoma	Phase 1
Completed	`NCT01393106` - Safety and Efficacy of Idelalisib in Relapsed or Refractory Hodgkin Lymphoma	Phase 2
Terminated	`NCT00992030` - R-ABVD vs ABVD-RT in Early Stage Hodgkin's Lymphoma	Phase 3
Terminated	`NCT00722865` - Avastin (Bevacizumab) Plus Adriamycin, Bleomycin, Vinblastine and Dacarbazine (ABVD) for Advanced Stage Hodgkin Lymphoma	Phase 2
Unknown status	`NCT00598624` - Clinical Trial to Evaluate the Safety and Efficacy of Treosulfan Based Conditioning Prior to Allogeneic Haematopoietic Stem Cell Transplantation (HSCT)	Phase 2
Completed	`NCT03242902` - To Decrease Fatigue With Light Therapy	Phase 3
Active, not recruiting	`NCT05205512` - Telehealth Exercise Intervention to Improve Cardiovascular Health in Lymphoma Survivors, TECHS Trial	N/A
Recruiting	`NCT03681561` - Nivolumab With Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma	Phase 1/Phase 2
Recruiting	`NCT03250962` - SHR-1210 Alone or in Combination With Decitabine in Relapsed or Refractory Hodgkin Lymphoma	Phase 2
Recruiting	`NCT04510610` - Camrelizumab Plus Decitabine in Anti-PD-1 Treatment-naive Patients With Relapsed/Refractory Classical Hodgkin Lymphoma	Phase 2/Phase 3
Completed	`NCT06295211` - Brentuximab Vedotin Combined With Bendamustine Supercharge, a Low-toxicity and Efficient Salvage Regimen for Primary Refractory or First-relapsed Classic Hodgkin Lymphoma: Long-term Results of a Retrospective Monocenter Study.
Active, not recruiting	`NCT02256137` - A Longitudinal Assessment of Frailty in Young Adult Survivors of Childhood Cancer
Completed	`NCT02432235` - Study of ADCT-301 in Patients With Relapsed or Refractory Hodgkin and Non-Hodgkin Lymphoma	Phase 1