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NCT03081910 · ClinicalTrials.gov registry record · Phase 1
Autologous T-Cells Expressing a Second Generation CAR for Treatment of T-Cell Malignancies Expressing CD5 Antigen
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
- 54
- Enrollment target
- 2
- Study locations
NCT03081910: Recruiting Phase 1 study of T-cell Acute Lymphoblastic Leukemia and T-cell Acute Lymphoblastic Lymphoma, sponsored by Baylor College of Medicine.
NCT03081910 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 54 participants, roughly in line with the 54-participant average among 6 other T-cell Acute Lymphoblastic Leukemia trials with a reported enrollment target. The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03081910, 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
- 54 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. 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
Primary Outcome
Defined as the proportion of subjects in each group with DLT evaluated as per the CTCAE 4.0 with the exception of Cytokine Release Syndrome (CRS) and neurological toxicities that are related to T cell infusions.
Conditions Studied
Interventions
- GENETIC Autologous CD5.CAR/28zeta CAR T cells
- GENETIC Allogeneic CD5.CAR/28zeta CAR T cells
Study Locations (2)
Texas
- Houston Methodist Hospital - Houston
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2017-11-01 |
| Est. Completion | 2040-09-01 |
| Phase | Phase 1 |
What NCT03081910 shows while recruiting
NCT03081910 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, roughly in line with the 54-participant average among 6 other T-cell Acute Lymphoblastic Leukemia trials with a reported enrollment target.
The record links to 3 conditions, with T-cell Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Autologous CD5.CAR/28zeta CAR T cells is the first listed.
NCT03081910 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03081910 about?
NCT03081910 is a clinical study titled "Autologous T-Cells Expressing a Second Generation CAR for Treatment of T-Cell Malignancies Expressing CD5 Antigen". 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, antibodi...
What is the current status of trial NCT03081910?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2017-11-01. Estimated completion is 2040-09-01.
What conditions does trial NCT03081910 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 NCT03081910?
The interventions under investigation include: Autologous CD5.CAR/28zeta CAR T cells (GENETIC), Allogeneic CD5.CAR/28zeta CAR T cells (GENETIC).
Who is sponsoring clinical trial NCT03081910?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03081910 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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