Clinical trial NCT03768310: CD19.CAR-multiVSTs for Patients With CD19+ B-ALL or NHL Undergoing Related Allogeneic HSCT (CARMA)
Official title: Phase I Study of the Administration of CD19 Chimeric Antigen Receptor Multivirus-Specific Cytotoxic T Lymphocytes for Prophylaxis or Therapy of Relapse of CD19 Positive Malignancies After Allogeneic Hematopoietic Stem Cell Transplantation
Conditions: Non-hodgkin Lymphoma
Acute Lymphoblastic Leukemia
Summary: This study is for patients that are having a bone marrow or stem cell transplant for either a type of cancer of the blood called Leukemia or a cancer of the lymph nodes called Non-Hodgkin's Lymphoma (NHL). Although a transplant can cure leukemia or lymphoma, some people will relapse (return of the disease). In those who relapse, current treatment cures only a very small percentage. This study is being conducted to evaluate the safety of a new type of therapy that may help to decrease the risk of relapse or treat relapse after it has occurred.
The body has different ways of fighting infection and disease. This study combines two of those ways, antibodies and T cells. Antibodies are proteins that protect the body from bacterial and other diseases. T cells are infection-fighting blood cells that can kill other cells, including tumor cells. Antibodies and T cells have been used to treat patients with cancers; they have shown promise, but have not been strong enough to cure most patients.
The antibody used in this study is called anti-CD19. This antibody is attracted to cancer cells because of a substance on the outside of these cells called CD19. For this study, the anti-CD19 antibody has been changed so that instead of floating free in the blood it is now joined to T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor (also known as a CAR T cell). Although anti-CD19 antibodies or chimeric receptors can kill cancer cells, unfortunately they sometimes do not last long enough to destroy all of the cancer cells.
These CD19 chimeric receptor multivirus specific T cells are an investigational product not approved by the Food and Drug Administration.
The purpose of this study is to find the biggest dose of chimeric T cells that is safe to administer, to determine what the side effects are, to see how long the T cells last and to evaluate whether this therapy might help prevent infections and relapse in people with CD19+ leukemia or lymphoma having a bone marrow transplant.
Interventions:
description: Patients will be evaluated in the clinic and a single dose of CD19.CAR-multiVSTs will be given by intravenous injection on or after 30 days of the transplant (between days 30 and 90). A time period of 6 weeks will constitute the time for clinical safety monitoring.
name: CD19.CAR-multiVST for Group A
other_name: CAR T Cells
type: Biological
description: Patients will be evaluated in the clinic and a single dose of CD19.CAR-multiVSTs will be given by intravenous injection on or after 30 days of the bone marrow transplant. A time period of 6 weeks will constitute the time for clinical safety monitoring. If patients with relapse after transplant or those with evidence of disease before bone marrow transplant have at least a partial response to the treatment or have stable disease, they will be eligible to receive up to 6 additional doses of T cells separated by a minimum of four weeks. Patients are eligible to receive additional doses only after they have completed the initial 6-week clinical safety monitoring period.
name: CD19.CAR-multiVST for Group B
other_name: CAR T Cells
type: Biological
Study arms:
design_group_description: Group A: Patients with no evidence of disease after having a bone marrow transplant.<br/>T cells will be given at the specified dose on or after day 30 after the bone marrow transplant. Three dose levels will be studied in both groups of patients (Group A and Group B). The lowest dose level will be 2 x 10^7cells/m2 and the highest will be 10 x10^7cells/m2.
design_group_title: CD19.CAR-multiVST for Group A
design_group_type: Experimental
design_group_description: Group B: Patients with evidence of disease before bone marrow transplant OR have relapsed after bone marrow transplant.<br/>Patients in Group B will receive the T cells at the earliest feasible time point after the detection of disease, but no earlier than day 30 after the transplant. The three dose levels will be studied in both groups of patients (Group A and Group B). The lowest dose level will be 2 x 10^7cells/m2 and the highest will be 10 x10^7cells/m2.
design_group_title: CD19.CAR-multiVST for Group B
design_group_type: Experimental
Sponsor: Baylor College of Medicine
Collaborators: Center For Cell & Gene Therapy
The Methodist Hospital Research Institute
Drug name mappings:
name: Virus-specific-CD19.CAR(Baylor College of Medicine)
lang: EN