RECRUITING

CD30 CAR T Cells, Relapsed CD30 Expressing Lymphoma (RELY-30)

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

The subject has a type of lymph gland cancer called Lymphoma. The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancer. This research study combines two different ways of fighting disease: antibodies and T cells. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including tumor cells or cells that are infected with germs. Both antibodies and T cells have been used to treat patients with cancers; they both have shown promise, but have not been strong enough to cure most patients. Investigators hope that both will work better together. Investigators have found from previous research that they can put a new gene into T cells that will make them recognize cancer cells and kill them. They now want to test whether these genetically modified T cells given after chemotherapy will be more effective at killing cancer cells. The gene that will be put into the T cells makes an antibody called anti-CD30. This antibody sticks to lymphoma cells because of a substance on the outside of the cells called CD30. Anti-CD30 antibodies have been used to treat people with lymphoma, but have not been strong enough to cure most patients. For this study, the anti-CD30 antibody has been changed so that instead of floating free in the blood it is now joined to the T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor. These CD30 chimeric receptor-activated T cells (CD30.CAR T cells) seem to kill some of the tumor, but they don't last very long and so their chances of fighting the cancer are unknown. Several studies suggest that the infused T cells need room to be able to multiply and grow to accomplish their functions, and that this may not happen if there are too many other T cells in circulation. Because of that, doctors may use chemotherapy drugs to decrease the level of circulating T cells prior to the CD30.CAR T cells infusion. This is called "lymphodepletion" CD30.CAR T cells have previously been studied in lymphoma patients.

Official Title

Phase I Study of Relapsed CD30 Expressing Lymphoma Treated With CD30 CAR T Cells (RELY-30)

Quick Facts

Study Start:2017-05-08
Study Completion:2040-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02917083

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 CriteriaExclusion Criteria
  1. 1. Diagnosis of relapsed/refractory HL or NHL.
  2. 2. CD30 positive tumor as assayed in a CLIA certified pathology laboratory (result can be pending at this time)
  3. 3. Hgb ≥ 7.0 (may be a transfused value)
  4. 4. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
  5. 5. Karnofsky or Lansky score of \> 60%
  1. 1. Active infection with HIV or HTLV (can be pending at this time).
  2. 2. Active bacterial, fungal or viral infection.

Contacts and Locations

Study Contact

Carlos A Ramos, MD
CONTACT
832-824-4817
caramos@bcm.edu
Vicky Torrano, RN
CONTACT
832-824-7821
vxtorran@txch.org

Principal Investigator

Carlos A 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 A 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 Date2017-05-08
Study Completion Date2040-02

Study Record Updates

Study Start Date2017-05-08
Study Completion Date2040-02

Terms related to this study

Keywords Provided by Researchers

  • chimeric antigen receptors
  • immunotherapy
  • CAR T-cells
  • lymphoma

Additional Relevant MeSH Terms

  • Hodgkin's Lymphoma
  • Non-Hodgkin Lymphoma