RecruitingPhase 1NCT03081910

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

Phase 1 Therapy With Manufactured Autologous T-Cells Expressing a Second Generation Chimeric Antigen Receptor (CAR) for Treatment of T-Cell Malignancies Expressing CD5 Antigen


Sponsor

Baylor College of Medicine

Enrollment

54 participants

Start Date

Nov 1, 2017

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Max Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial uses CAR T-cell therapy — where immune cells (T-cells) are taken from a donor, genetically engineered to target a protein called CD5 on cancer cells, and then infused — to treat people with T-cell blood cancers (leukemia and lymphoma) that have come back after a bone marrow transplant. **You may be eligible if...** - You are under 75 years old with a T-cell blood cancer (such as T-cell leukemia, T-cell lymphoma, or Mycosis Fungoides stage IIB or higher) that has returned after treatment - Your cancer cells have a marker called CD5 on their surface (confirmed by a laboratory test) - You have a suitable stem cell transplant donor identified - You are in reasonably good health (Karnofsky/Lansky score of 60% or above) - Your liver, kidneys, and oxygen levels are within acceptable ranges **You may NOT be eligible if...** - You have an active HIV infection or an uncontrolled viral infection (such as EBV, CMV, or HHV-6) - You have significant graft-versus-host disease (a complication from a prior bone marrow transplant where donor cells attack your body) - You have active serious heart conditions (such as recent heart attack or severely reduced heart function) - You are pregnant or breastfeeding - You have a tumor in a location where swelling could block your airway Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETICAutologous CD5.CAR/28zeta CAR T cells

Three dose levels will be evaluated: Dose level one: 1×10\^7 cells/m2 Dose level two: 5×10\^7 cells/m2 Dose level three: 1×10\^8 cells/m2

GENETICAllogeneic CD5.CAR/28zeta CAR T cells

Three dose levels will be evaluated: Dose level one: 1×10\^7 cells/m2 Dose level two: 5×10\^7 cells/m2 Dose level three: 1×10\^8 cells/m2


Locations(2)

Houston Methodist Hospital

Houston, Texas, United States

Texas Children's Hospital

Houston, Texas, United States

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NCT03081910


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