RECRUITING

Allogeneic CD30.CAR-EBVSTs in Patients With Relapsed or Refractory CD30-Positive Lymphomas

Conditions

Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type Classical Hodgkin Lymphoma CD30-Positive Lymphoma Hodgkin lymphoma non-Hodgkin lymphoma CD30 CAR

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2020-09-16

Study Completion:2037-06-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04288726

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Diagnosis and clinical course falling into one of the following categories: 1. Hodgkin lymphoma 2. Aggressive non-Hodgkin lymphoma 3. ALK-negative anaplastic T cell lymphoma or other peripheral T-cell lymphoma 4. ALK-positive anaplastic T cell lymphoma 2. CD30-positive tumor as assayed in a CLIA certified Pathology Laboratory. 3. Age 12 to 75. 4. Bilirubin 2 times (or 3 times if the patient has Gilbert syndrome) or less than the upper limit of normal. 5. AST 3 times or less than the upper limit of normal. 6. Estimated GFR \> 70 mL/min. 7. Pulse oximetry of \> 90% on room air 8. EKG shows no significant arrhythmias 9. Karnofsky or Lansky score of \> 60%. 10. Available allogeneic T cells with ≥15% expression of CD30CAR determined by flow-cytometry. 11. Recovered from all acute non-hematologic toxic effects of all prior chemotherapy. 12. 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. 13. Informed consent explained to, understood by and signed by patient or guardian. Patient or guardian given a copy of the informed consent form.	1. Received an investigational cell therapy or vaccine within the past 6 weeks. 2. Received an investigational small molecule drug within the past 2 weeks. 3. Received CD30 antibody-based therapy within the previous 4 weeks. 4. Received gemcitabine-containing chemotherapy within the previous 12 weeks 5. History of hypersensitivity reactions to murine protein-containing products. 6. Pregnant or lactating. 7. Tumor in a location where enlargement could cause airway obstruction (determined at the investigators' discretion). 8. Current use of systemic corticosteroids at a dose equivalent to higher than 10 mg/day of prednisone. 9. Active significant, uncontrolled bacterial, viral or fungal infection. 10. Symptomatic cardiac disease (NYHA Class III or IV disease).

Inclusion Criteria

Exclusion Criteria

1. Diagnosis and clinical course falling into one of the following categories:
1. Hodgkin lymphoma
2. Aggressive non-Hodgkin lymphoma
3. ALK-negative anaplastic T cell lymphoma or other peripheral T-cell lymphoma
4. ALK-positive anaplastic T cell lymphoma
2. CD30-positive tumor as assayed in a CLIA certified Pathology Laboratory.
3. Age 12 to 75.
4. Bilirubin 2 times (or 3 times if the patient has Gilbert syndrome) or less than the upper limit of normal.
5. AST 3 times or less than the upper limit of normal.
6. Estimated GFR \> 70 mL/min.
7. Pulse oximetry of \> 90% on room air
8. EKG shows no significant arrhythmias
9. Karnofsky or Lansky score of \> 60%.
10. Available allogeneic T cells with ≥15% expression of CD30CAR determined by flow-cytometry.
11. Recovered from all acute non-hematologic toxic effects of all prior chemotherapy.
12. 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.
13. Informed consent explained to, understood by and signed by patient or guardian. Patient or guardian given a copy of the informed consent form.

1. Received an investigational cell therapy or vaccine within the past 6 weeks.
2. Received an investigational small molecule drug within the past 2 weeks.
3. Received CD30 antibody-based therapy within the previous 4 weeks.
4. Received gemcitabine-containing chemotherapy within the previous 12 weeks
5. History of hypersensitivity reactions to murine protein-containing products.
6. Pregnant or lactating.
7. Tumor in a location where enlargement could cause airway obstruction (determined at the investigators' discretion).
8. Current use of systemic corticosteroids at a dose equivalent to higher than 10 mg/day of prednisone.
9. Active significant, uncontrolled bacterial, viral or fungal infection.
10. Symptomatic cardiac disease (NYHA Class III or IV disease).

Contacts and Locations

Study Contact

Carlos Ramos, MD

CONTACT

832-824-4817

caramos@bcm.edu

Vicky Torrano

CONTACT

(832) 824-7821

vtorrano@bcm.edu-

Principal Investigator

Carlos Ramos, MD

PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Study Locations (Sites)

Houston Methodist Hospital

Houston, Texas, 77030

United States

Texas Children's Hospital

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Baylor College of Medicine

Carlos Ramos, MD, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-16

Study Completion Date2037-06-01

Study Record Updates

Study Start Date2020-09-16

Study Completion Date2037-06-01

Terms related to this study

Keywords Provided by Researchers

CD30-Positive Lymphoma
Hodgkin lymphoma
non-Hodgkin lymphoma
CD30 CAR

Additional Relevant MeSH Terms

Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type
Classical Hodgkin Lymphoma