Actively Recruiting

Phase 1
Age: 0 - 75Years
All Genders
NCT03690011

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

Led by Baylor College of Medicine · Updated on 2025-10-23

27

Participants Needed

2

Research Sites

978 weeks

Total Duration

On this page

Sponsors

B

Baylor College of Medicine

Lead Sponsor

T

The Methodist Hospital Research Institute

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. 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 0 - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of recurrent or refractory T-cell acute lymphoblastic leukemia, T-cell acute lymphoblastic lymphoma, T-non-Hodgkin lymphoma (including various subtypes) or other cutaneous T-cell lymphomas
  • Suitable for allogeneic hematopoietic stem cell transplant with a suitable donor identified
  • Willing to proceed to transplant if complete remission is achieved with CD7.CAR treatment
  • Tumor with at least 20% CD7-positive blasts confirmed by certified laboratory
  • Age 75 years or younger; first three patients must be adults (18 years or older)
  • Hemoglobin level of 7.0 or higher (transfusions allowed)
  • Life expectancy greater than 12 weeks
  • Kidney and liver function within defined limits if blood collection is needed
  • Informed consent explained, understood, and signed by patient or guardian
Not Eligible

You will not qualify if you...

  • Active infection requiring antibiotics
  • Active HIV infection
  • History of other cancers except certain skin or in situ cancers treated curatively at least 2 years prior
  • Currently receiving other investigational agents or tumor vaccines within 6 weeks
  • Known hypersensitivity to murine protein-containing products
  • Pregnant or lactating
  • Tumor in location where growth could block airway
  • Clinically significant viral infections or uncontrolled viral reactivation
  • Certain heart conditions including recent heart attack, atrial fibrillation, severe heart dysfunction, or significant pericardial effusion
  • Central nervous system abnormalities such as CNS-3 disease, uncontrolled seizures, recent stroke, dementia, cerebellar disease, or autoimmune CNS diseases

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

L

LaQuisa Hill, MD

CONTACT

M

Martha Arredondo

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Cell Therapy for High Risk T-Cell Malignancies Using CD7-Specific CAR Expressed On Autologous T Cells | DecenTrialz