RECRUITING

Cell Therapy for High Risk T-Cell Malignancies Using CD7-Specific CAR Expressed on Autologous T Cells

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

Patients eligible for this study have a type of blood cancer called T-cell leukemia or lymphoma (lymph gland cancer). The body has different ways of fighting infection and disease. This study combines two different ways of fighting disease with antibodies and T cells. Antibodies are types of proteins that protect the body from bacterial and other diseases. T cells, or T lymphocytes, are special infection-fighting blood cells that can kill other cells including tumor cells. Both antibodies and T cells have been used to treat cancer; they have shown promise, but have not been strong enough to cure most patients. T cells can kill tumor cells but there normally are not enough of them to kill all the tumor cells. Some researchers have taken T cells from a person's blood, grown more of them in the laboratory and then given them back to the person. The antibody used in this study is called anti-CD7. This antibody sticks to T-cell leukemia or lymphoma cells because of a substance on the outside of these cells called CD7. CD7 antibodies have been used to treat people with T-cell leukemia and lymphoma. For this study, anti-CD7 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. In the laboratory, investigators have also found that T cells work better if they also add proteins that stimulate T cells, such as one called CD28. Adding the CD28 makes the cells grow better and last longer in the body, thus giving the cells a better chance of killing the leukemia or lymphoma cells. In this study, investigators attach the CD7 chimeric receptor with CD28 added to it to T cells. Investigators will then test how long the cells last. These CD7 chimeric receptor T cells with CD28 are investigational products not approved by the Food and Drug Administration.

Official Title

Cell Therapy for High Risk T-cell Malignancies Using CD7-Specific CAR Expressed on Non-Edited T Cells (CRIMSON-NE)

Quick Facts

Study Start:2021-08-02
Study Completion:2040-05-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03690011

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:Not specified 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 recurrent or refractory T-cell acute lymphoblastic leukemia (T-ALL), T-cell acute lymphoblastic lymphoma (T-LLy), or T-non-Hodgkin lymphoma (T-NHL, including Angioimmunoblastic T-cell lymphoma (AITL), Enteropathy-associated T-cell lymphoma (EATL), Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL), Peripheral T-cell lymphoma (PTCL) NOS, Anaplastic large cell lymphoma (ALCL), Adult T-cell leukemia/lymphoma, T cell prolymphocytic leukemia with symptomatic disease, Extranodal NK/T cell lymphoma, Mycosis fungoides/ Sezary Syndrome Stage IIB or higher) or other cutaneous T-cell lymphomas
  2. 1. suitable for allogeneic hematopoietic stem cell transplant (HSCT)
  3. 2. with a suitable donor identified by a FACT accredited transplant center
  4. 3. willing to proceed to transplant if the CD7.CAR treatment induces complete remission and the patient/donor remain suitable candidates
  5. * For T-NHL subjects, eligibility will be confined to disease stages where allogeneic HSCT is indicated.
  6. 2. CD7-positive tumor (≥20% CD7 positive blasts by flow cytometry or immunohistochemistry (tissue) assessed by a CLIA certified Flow Cytometry/Pathology laboratory).
  7. 3. Age \</=75 years old.. NOTE: The first three (3) patients treated on the study must be adults (\>/=18 yrs of age).
  8. 4. Hgb ≥ 7.0 (can be transfused)
  9. 5. Life expectancy greater than 12 weeks
  10. 6. If pheresis required to collect blood:
  11. * Cr \< 1.5 upper limit normal
  12. * AST \< 5 × upper limit normal
  13. * PT and APTT \<1.5 × upper limit normal
  14. 7. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
  1. 1. Active infection requiring antibiotics.
  2. 2. Active infection with HIV
  3. 3. History of other cancer (except non-melanoma skin cancer or in situ breast cancer or cervix cancer) unless the tumor was successfully treated with curative intent at least 2 years before trial entry.

Contacts and Locations

Study Contact

LaQuisa Hill, MD
CONTACT
713-441-1450
LaQuisa.Hill@bcm.edu
Martha Arredondo
CONTACT
832-824-1201
Martha.Arredondo@bcm.edu

Principal Investigator

Rayne Rouce, MD
PRINCIPAL_INVESTIGATOR
Pediatrics, Baylor College of Medicine
LaQuisa Hill, MD
PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Maksim Mamonkin, PhD
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

  • Rayne Rouce, MD, PRINCIPAL_INVESTIGATOR, Pediatrics, Baylor College of Medicine
  • LaQuisa Hill, MD, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine
  • Maksim Mamonkin, PhD, 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 Date2021-08-02
Study Completion Date2040-05-01

Study Record Updates

Study Start Date2021-08-02
Study Completion Date2040-05-01

Terms related to this study

Keywords Provided by Researchers

  • Autologous CAR T cells
  • T-cell acute lymphoblastic lymphoma
  • T-non-Hodgkin lymphoma
  • T-cell Acute Lymphoblastic Leukemia

Additional Relevant MeSH Terms

  • T-cell Acute Lymphoblastic Lymphoma
  • T-non-Hodgkin Lymphoma
  • T-cell Acute Lymphoblastic Leukemia