NCT04952584

A Phase 1 Study Evaluating the Safety and Activity of Allogeneic CD30 Chimeric Antigen Receptor Epstein-Barr Virus-Specific T Lymphocytes (CD30.CAR-EBVSTs) in Patients With Relapsed or Refractory CD30-Positive Lymphomas

Withdrawn Phase 1 Last updated 2 September 2023

What this trial tests

Phase 1 trial testing CD30.CAR-EBVST cells in Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type. Withdrawn.

Timeline

1 March 2024

Primary endpoint
1 June 2025

1 June 2040

Quick facts

Lead sponsor	Baylor College of Medicine
Phase	Phase 1
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	1 March 2024
Primary completion	1 June 2025
Estimated completion	1 June 2040
Sites	2 locations across United States

Drugs / interventions tested

• CD30.CAR-EBVST cells — full drug profile →

Conditions studied

• Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type — all drugs for Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type →
• Classical Hodgkin Lymphoma — all drugs for Classical Hodgkin Lymphoma →

Sponsor

Baylor College of Medicine

Who can join

Adults 12 to 75, any sex, with Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type or Classical Hodgkin Lymphoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Dose limiting toxicity rate (DLT) by CTCAE 5.0
  Time frame: 28 Days
  Any Grade 5 event, / Non-hematologic dose-limiting toxicity is any Grade 3 or Grade 4 non-hematologic toxicity that fails to return to Grade 2 within 72 hours, / Grade 2-4 allergic reaction to T-Cells, / Grade 3-4 GVHD, / Grade 3-4 CRS. Toxicity will be evaluated according to the CTCAE Version 5.0. GVHD will be graded by the method of Przepiorka et al.

Sponsor's own description

This study involved patients that have a cancer called diffuse large B cell lymphoma (DLBCL), NK and T cell lymphomas (NK/TL) or classical Hodgkin lymphoma (cHL) (hereafter these 3 diseases will be referred to as lymphoma). Patients lymphoma has come back or not gone away after treatment. Because there is no standard treatment for the patients cancer at this time or because the currently used treatments do not work fully in all cases, the patients are being asked to volunteer in this research study.

In this study the investigators want to test a type of T cell made from a normal donor. The T cells the investigators will use are called Epstein Barr virus (EBV) specific T cells (EBVSTs) and are cells that the investigators have trained in the laboratory to recognize a EBV which is the virus that causes mono or kissing disease. Some patients with lymphoma have EBV in their cancer cells. Researchers have given T cell lines from normal donor EBVSTs to lymphoma patients who have EBV in their lymphoma cells and have seen responses in about half the patients. The cells have have been generated and are frozen in a bank. The cells are called "allogeneic" (meaning the donor is not related to the patient). CD30.CAR in EBV-specific T cells (called allogeneic CD30.CAR-EBVST) from the blood of healthy donors. The investigators are giving the cells to patients with lymphoma cells that express CD30. If the lymphoma cells also express EBV there may be some benefit from targeting both proteins.

The purpose of this study is to find out the highest safe dose of allogeneic CD30.CAR-EBVST cells given following chemotherapy and used to treat lymphoma. The investigators will learn the side effects of CD30.CAR-EBVST cells in patients and see whether this therapy may help lymphoma patients.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Recent updates on allogeneic CAR-T cells in hematological malignancies.
   Mansoori S, Noei A, Maali A, Seyed-Motahari SS, et al · · 2024 · cited 34× · PMID 39227937 · DOI 10.1186/s12935-024-03479-y
2. Treatment of extranodal NK/T-cell lymphoma: From past to future.
   Yan Z, Yao S, Wang Z, Zhou W, et al · · 2023 · cited 22× · PMID 36825002 · DOI 10.3389/fimmu.2023.1088685
3. CAR T-Cell Immunotherapy Treating T-ALL: Challenges and Opportunities.
   Ren A, Tong X, Xu N, Zhang T, et al · · 2023 · cited 17× · PMID 36680011 · DOI 10.3390/vaccines11010165
4. The application of autologous cancer immunotherapies in the age of memory-NK cells.
   Lizana-Vasquez GD, Torres-Lugo M, Dixon RB, Powderly JD, et al · · 2023 · cited 16× · PMID 37205105 · DOI 10.3389/fimmu.2023.1167666
5. Advances in Hodgkin Lymphoma Treatment: From Molecular Biology to Clinical Practice.
   Benevolo Savelli C, Bisio M, Legato L, Fasano F, et al · · 2024 · cited 14× · PMID 38791909 · DOI 10.3390/cancers16101830
6. Adoptive Cell Therapy for T-Cell Malignancies.
   Fang KK, Lee JB, Zhang L. · · 2022 · cited 8× · PMID 36612092 · DOI 10.3390/cancers15010094
7. The optimal management of relapsed and refractory Hodgkin lymphoma: post-brentuximab and checkpoint inhibitor failure.
   Grover NS, Dittus C, Thakkar A, Beaven AW. · · 2023 · cited 7× · PMID 38066906 · DOI 10.1182/hematology.2023000450
8. Genetic lesions and targeted therapy in Hodgkin lymphoma.
   Li Z, Mu W, Xiao M. · · 2023 · cited 7× · PMID 36654739 · DOI 10.1177/20406207221149245