NCT04952584WithdrawnPhase 1
Allogeneic CD30 Chimeric Antigen Receptor Epstein-Barr Virus-Specific T Lymphocytes in Relapsed or Refractory CD30-Positive Lymphomas
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
Source: ClinicalTrials.gov · Last updated 7 Sept 2023
Reason given: Study was not activated
Brief summary (registry, in English)
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.
- Status (registry)
- Withdrawn
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 28 Jun 2021
- Start date
- Mar 2024
- Primary completion date
- Jun 2025
- Lead sponsor
- Baylor College of Medicine
- Diseases
- Childhood cancers, Hodgkin lymphoma
- NCT number
- NCT04952584
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently receiving any investigational agents or received any tumor vaccines within the previous six weeks.
- Received CD30 antibody-based therapy within the previous 4 weeks.
- Current use of systemic corticosteroids at a dose equivalent to higher than 10 mg/day of prednisone.
Other illness
- History of hypersensitivity reactions to murine protein-containing products.
- Active significant, uncontrolled bacterial, viral or fungal infection.
- Symptomatic cardiac disease (NYHA Class III or IV disease).
Other
- Pregnant or lactating.
- Tumor in a location where enlargement could cause airway obstruction.
Who the study is looking for
- Diagnosis and clinical course falling into one of the following categories:
- Hodgkin lymphoma
- Aggressive non-Hodgkin lymphoma
- ALK-negative anaplastic T cell lymphoma or other peripheral T-cell lymphoma
- ALK-positive anaplastic T cell lymphoma
- CD30-positive tumor as assayed in a CLIA certified Pathology Laboratory.
- Age 12 to 75.
- Bilirubin 2 times (or 3 times if the patient has Gilbert syndrome) or less than the upper limit of normal.
- AST 3 times or less than the upper limit of normal.
- Estimated GFR > 70 mL/min.
- Pulse oximetry of > 90% on room air
- EKG shows no significant arrhythmias
- Karnofsky or Lansky score of > 60%.
- Available allogeneic T cells with ≥15% expression of CD30CAR determined by flow-cytometry.
- Recovered from all acute non-hematologic toxic effects of all prior chemotherapy.
- Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom.
- Informed consent explained to, understood by and signed by patient or guardian. Patient or guardian given a copy of the informed consent form.
Age in the registry: 12 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Houston Methodist Hospital | Houston | United States | Unknown status |
| Texas Children's Hospital | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.