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NCT03690011 · ClinicalTrials.gov registry record · Phase 1
Cell Therapy for High Risk T-Cell Malignancies Using CD7-Specific CAR Expressed On Autologous T Cells
A Phase 1 study of T-cell Acute Lymphoblastic Leukemia and T-cell Acute Lymphoblastic Lymphoma, sponsored by Baylor College of Medicine.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
- 2
- Study locations
NCT03690011: Recruiting Phase 1 study of T-cell Acute Lymphoblastic Leukemia and T-cell Acute Lymphoblastic Lymphoma, sponsored by Baylor College of Medicine.
NCT03690011 is a Phase 1 study of T-cell Acute Lymphoblastic Leukemia and T-cell Acute Lymphoblastic Lymphoma that is actively recruiting participants, run by Baylor College of Medicine. The registered enrollment target is 27 participants, below the 59-participant average among 6 other T-cell Acute Lymphoblastic Leukemia trials with a reported enrollment target (54% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03690011, a Phase 1 study of T-cell Acute Lymphoblastic Leukemia and T-cell Acute Lymphoblastic Lymphoma, is actively recruiting participants, sponsored by Baylor College of Medicine.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
- 2
- Study locations
Study 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. 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.
Primary Outcome
To evaluate the safety of escalating doses of autologous peripheral blood T lymphocytes (ATLs) genetically modified to express chimeric antigen receptors (CAR) targeting the CD7 molecule (CD7.CAR) in combination with lymphodepletion in patients with relapsed/refractory T-cell malignancies.
Conditions Studied
Interventions
- GENETIC CD7.CAR/28zeta CAR T cells
Study Locations (2)
Texas
- Houston Methodist Hospital - Houston
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2021-08-02 |
| Est. Completion | 2040-05-01 |
| Phase | Phase 1 |
What NCT03690011 shows while recruiting
NCT03690011 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 59-participant average among 6 other T-cell Acute Lymphoblastic Leukemia trials with a reported enrollment target (54% lower).
The record links to 3 conditions, with T-cell Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 1 intervention - of which CD7.CAR/28zeta CAR T cells is the first listed.
NCT03690011 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03690011 about?
NCT03690011 is a clinical study titled "Cell Therapy for High Risk T-Cell Malignancies Using CD7-Specific CAR Expressed On Autologous T Cells". 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 protei...
What is the current status of trial NCT03690011?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2021-08-02. Estimated completion is 2040-05-01.
What conditions does trial NCT03690011 study?
This clinical trial studies the following conditions: T-cell Acute Lymphoblastic Leukemia, T-cell Acute Lymphoblastic Lymphoma, T-non-Hodgkin Lymphoma.
What interventions are being tested in trial NCT03690011?
The interventions under investigation include: CD7.CAR/28zeta CAR T cells (GENETIC).
Who is sponsoring clinical trial NCT03690011?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03690011 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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