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New treatment option for Juvenile Myelomonocytic Leukemia
Official title HA-1 T TCR T Cell Immunotherapy for the Treatment of Patients With Relapsed or Refractory Acute Leukemia After Donor Stem Cell Transplant
ClinicalTrials.gov ID: NCT03326921
What this study is testing
What is CD8+ and CD4+ Donor Memory T-cells-expressing HA1-Specific TCR?
CD8+ and CD4+ Donor Memory T-cells-expressing HA1-Specific TCR is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for juvenile myelomonocytic leukemia.
Also referred to as CD8+ and CD4+ Donor Memory T-cells-expressing pRRLSIN iC9-HA1 TCR2-RQR-CD8, HA-1 TCR CD8+ and CD4+ Tm Cells.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase I trial studies the side effects and best dose of CD4+ and CD8+ HA-1 T cell receptor (TCR) (HA-1 T TCR) T cells in treating patients with acute leukemia that persists, has come back (recurrent) or does not respond to treatment (refractory) following donor stem cell transplant. T cell receptor is a special protein on T cells that helps them recognize proteins on other cells including leukemia.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 80
You may be able to join if
- Subject age 0-80 years at the time of enrollment.
- Subject must express HLA-A\ 0201
- Subject must have the HA-1(H) genotype (RS\_1801284: A/G, A/A)
- Subject must have an adult donor for HCT who is adequately HLA matched by institutional standards (includes HLA-matched related or unrelated donors...
- HLA-A\ 0201 positive and HA-1(H) negative (RS\_1801284: G/G) or
You likely can't join if
- Medical or psychological conditions that would make the subject unsuitable candidate for cell therapy at the discretion of the principal investigator...
- Fertile people unwilling to use contraception during and for 12 months after treatment
- people with a life expectancy of \< 3 months of enrollment from coexisting disease other than leukemia
- people who have ongoing grade IV acute GVHD or severe chronic GVHD following most recent transplant. Exception: the principal investigator (PI) may...
- The presence of organ toxicities will not necessarily exclude people from enrolling on the protocol at the discretion of the PI; however, a delay in...
- Donors who are human immunodeficiency virus (HIV)-1, HIV-2, human T-lymphotropic virus (HTLV)-1, HTLV-2 seropositive or with active hepatitis B or...
See the full eligibility criteria
- Subject age 0-80 years at the time of enrollment.
- Subject must express HLA-A\ 0201
- Subject must have the HA-1(H) genotype (RS\_1801284: A/G, A/A)
- Subject must have an adult donor for HCT who is adequately HLA matched by institutional standards (includes HLA-matched related or unrelated donors, and HLA-mismatched family donors, including haploidentical donors) and...
- HLA-A\ 0201 positive and HA-1(H) negative (RS\_1801284: G/G) or
- HLA-A\ 0201 negative
- people who are currently undergoing or who previously underwent allogeneic HCT for
- Acute myeloid leukemia (AML) of any subtype
- Acute lymphoid leukemia (ALL) of any subtype
- Mixed phenotype/undifferentiated/any other type of acute leukemia, including blastic plasmacytoid dendritic cell neoplasm
- Chronic myeloid leukemia with a history of blast crisis and:
- With relapse or refractory disease (\>= 5% marrow blasts, or circulating blasts) at any time after HCT
- With persistent rising minimal residual disease (defined as detectable disease by morphology, flow cytometry, molecular or cytogenetic testing but \ = 2 of two consecutive tests), refractory or ineligible for treatment...
- Myelodysplastic syndrome (MDS) of any subtype
- Chronic myelomonocytic leukemia (CMML)
- Juvenile myelomonocytic leukemia (JMML)
- people must be able to understand and be willing to give informed consent; decision-impaired adults may consent with their legally authorized representative; parent or legal representative will be asked to consent for...
- people must agree to participate in long-term follow-up for up to 15 years if they are enrolled in the study and receive T cell infusion
- people who have relapsed or have MRD after HCT may receive other agents for treatment of disease and remain eligible for the protocol
- A specific performance status score is not required for enrolling on the protocol; a delay in infusion of the HA-1 TCR T cells may be required for people with low performance status DONOR SELECTION INCLUSION
- Donor age \>= 18 years
- Donors must be able to give informed consent
- Medical or psychological conditions that would make the subject unsuitable candidate for cell therapy at the discretion of the principal investigator (PI)
- Fertile people unwilling to use contraception during and for 12 months after treatment
- people with a life expectancy of \< 3 months of enrollment from coexisting disease other than leukemia
- people who have ongoing grade IV acute GVHD or severe chronic GVHD following most recent transplant. Exception: the principal investigator (PI) may make an exception on a case-by-case basis to include such a subject if...
- The presence of organ toxicities will not necessarily exclude people from enrolling on the protocol at the discretion of the PI; however, a delay in the infusion of HA-1 TCR T cells may be required DONOR SELECTION...
- Donors who are human immunodeficiency virus (HIV)-1, HIV-2, human T-lymphotropic virus (HTLV)-1, HTLV-2 seropositive or with active hepatitis B or hepatitis C virus infection
- Unrelated donor residing outside of the United States of America (USA) unless the donor screening, testing and leukapheresis occur at an National Marrow Donor Program (NMDP)-affiliated and qualified donor center and are...
The study team makes the final eligibility decision.
Where it's taking place
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.