Actively Recruiting

Phase 1
Age: 0 - 75Years
All Genders
NCT03081910

Autologous T-Cells Expressing a Second Generation CAR for Treatment of T-Cell Malignancies Expressing CD5 Antigen

Led by Baylor College of Medicine · Updated on 2025-09-04

54

Participants Needed

2

Research Sites

1191 weeks

Total Duration

On this page

Sponsors

B

Baylor College of Medicine

Lead Sponsor

C

Center for Cell and Gene Therapy, Baylor College of Medicine

Collaborating Sponsor

AI-Summary

What this Trial Is About

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. No one way seems perfect for fighting cancers. This research combines two different ways of fighting disease, antibodies and T cells. Antibodies are 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 shown promise treating patients with cancers, but have not been strong enough to cure most patients. T lymphocytes can kill tumor cells but there normally are not enough of them. Some researchers have taken T cells from a person's blood, grown more in the lab then given them back to the person. In some patients who've had recent bone marrow or stem cell transplant, the number of T cells in their blood may not be enough to grow in the lab. In this case, T cells may be collected from their previous transplant donor, who has a similar tissue type. The antibody used in this study, called anti-CD5, first came from mice that have developed immunity to human leukemia. This antibody sticks to T-cell leukemia or lymphoma cells because of a substance on the outside of these cells called CD5. CD5 antibodies have been used to treat people with T-cell leukemia and lymphoma. For this study, anti-CD5 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 lab, investigators have also found that T cells work better if stimulating proteins, such as one called CD28, are also added. Adding the CD28 makes the cells grow better and last longer in the body, giving them a better chance of killing the leukemia or lymphoma cells. In this study investigators will attach the CD5 chimeric receptor with CD28 added to it to the patient's T cells or the previous bone marrow transplant donor's T cells. The investigators will then test how long the cells last. The decision to use the bone marrow transplant donor's T cells instead of the patient's will be based on 1) whether there is an available and willing donor and 2) the likelihood of the patient's T cells being able to grow in the lab. These CD5 chimeric receptor T cells with CD28 are investigational products not approved by the FDA. UPDATE: Please note that the Autologous Arm of this study is now closed.

CONDITIONS

Official Title

Autologous T-Cells Expressing a Second Generation CAR for Treatment of T-Cell Malignancies Expressing CD5 Antigen

Who Can Participate

Age: 0 - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of recurrent T-cell acute lymphoblastic leukemia, T-cell acute lymphoblastic lymphoma, or T-cell non-Hodgkin lymphoma, including specific subtypes
  • For patients: transplant naive or relapsed post-allogeneic HSCT; for donors: relapsed post-allogeneic HSCT with eligible previous HSCT donor
  • Suitable for allogeneic hematopoietic stem cell transplant with a confirmed eligible donor
  • Plan to proceed with transplant if complete remission is achieved
  • Tumor positive for CD5 antigen on more than 50% of blasts by certified testing
  • Age 18 to less than 75 years
  • Life expectancy greater than 12 weeks
  • Availability of a partially HLA-matched allogeneic EBV-specific T cell line for uncontrolled EBV reactivation
  • Hemoglobin level at least 7.0 g/dL (transfusion allowed)
  • Ifpheresis required: creatinine, AST, PT, and APTT less than 1.5 times upper limit normal
  • Bilirubin less than 3 times upper limit normal
  • AST less than 5 times upper limit normal
  • Estimated glomerular filtration rate greater than 60 mL/min
  • Pulse oximetry greater than 90% on room air
  • Karnofsky or Lansky performance score of 60% or higher
  • Recovery from acute effects of prior chemotherapy at least one week before study entry
  • At least 60 days post-allogeneic HSCT at treatment
  • Sexually active patients agree to use effective birth control during and for 6 months after the study
  • Informed consent given and understood
Not Eligible

You will not qualify if you...

  • Active infection requiring antibiotics
  • Active HIV infection
  • History of other cancer except certain treated skin or breast/cervix cancers unless cured for at least 2 years
  • Current use of investigational agents or tumor vaccines within 6 weeks
  • Hypersensitivity to murine protein-containing products
  • Pregnant or breastfeeding women
  • Tumor location that risks airway obstruction if enlarged
  • Clinically significant viral infections or uncontrolled viral reactivation (EBV, CMV, Adv, BK-virus, HHV-6)
  • Acute graft versus host disease above grade II or active chronic GVHD beyond mild
  • Use of corticosteroids for GVHD above 0.5 mg/kg prednisone equivalent
  • Immunosuppressive treatment or donor lymphocyte infusion within 28 days before infusion
  • Certain serious cardiac conditions or dysfunction
  • Central nervous system disorders including CNS-3 disease, uncontrolled seizures, recent stroke, dementia, cerebellar disease, or autoimmune CNS disease

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Houston Methodist Hospital

Houston, Texas, United States, 77030

Actively Recruiting

2

Texas Children's Hospital

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

R

Rayne Rouce, MD

CONTACT

M

Martha Arredondo

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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