Novel Unedited Allo Cell Therapy For High Risk T-Cell Malignancies Using CD7-Specific Car T Cells

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
AgeUp to 75
SponsorBaylor College of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

suitable for allogeneic hematopoietic stem cell transplant (HSCT)

with a suitable donor identified by a FACT accredited transplant center

willing to proceed to transplant if the CD7.CAR treatment induces complete remission and the patient/donor remain suitable candidates.

CD7-positive tumor (≥20% CD7 positive blasts by flow cytometry or immunohistochemistry (tissue) assessed by a CLIA certified Flow Cytometry/Pathology laboratory).

Disqualifiers

Active infection requiring antibiotics

Active infection with HIV

History of other cancer (except non-melanoma skin cancer or in situ breast cancer or cervical cancer) unless the tumor was successfully treated with curative intent at least 2 years before trial entry.

suitable for allogeneic hematopoietic stem cell transplant (HSCT)

Trial design

Design model

Single group

Treatments tested in this trial

  • CD7.CAR/28zeta T Cells

    Genetic

    Fourdose levels will be evaluated: Dose level one: 1×10\^7 cells/m\^2 Dose level two: 3×10\^7 cells/m\^2 Dose level three: 5x10\^7 cells/m\^2 Dose level four: 1×10\^8 cells/m\^2

Treatment groups

27 Participants
are divided into 1 treatment group
Group A: CD7.CAR/28zeta T CellsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose limiting toxicity rate

Defined as the proportion of subjects in each group with DLT evaluated as per the CTCAE 5.0 with the exception of Cytokine Release Syndrome (CRS) and neurological toxicities that are related to T cell infusions.

Time frame
4 weeks

Secondary outcomes

1

Overall Response Rate

Overall response rate is calculated as the proportion of subjects with the best overall response according to protocol defined response criteria.

Time frame
4 weeks

Other outcomes

Sponsors and contacts

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Baylor College of Medicine

Lead sponsor

The Methodist Hospital Research Institute

Collaborator