TregGraft (Orca-T) for Myelodysplastic Syndromes

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Winship Cancer Institute - Emory University, Atlanta, GA
Myelodysplastic Syndromes+9 More
TregGraft (Orca-T) - Biological
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a type of white blood cell called regulatory T cells may help treat certain types of cancer.

See full description

Eligible Conditions

  • Myelodysplastic Syndromes
  • Acute Myeloid Leukemia (AML)
  • Acute Lymphoblastic Leukemia (ALL)
  • Acute Leukemia (Category)
  • Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether TregGraft (Orca-T) will improve 1 primary outcome and 5 secondary outcomes in patients with Myelodysplastic Syndromes. Measurement will happen over the course of 28 days.

28 days
incidence and timing of engraftment
365 days
1 year graft-versus-host-disease-free and relapse-free survival (GRFS)
1-year overall survival (OS)
TregGraft (Orca-T), with single agent GVHD prophylaxis
incidence and severity of acute and chronic graft vs host disease (GvHD)
incidence of serious infections

Trial Safety

Safety Estimate

1 of 3

Trial Design

1 Treatment Group

Subjects with Acute Leukemia or Myelodysplasic Syndrome, Myelofibrosis, or BPDCN
1 of 1
Experimental Treatment

This trial requires 84 total participants across 1 different treatment group

This trial involves a single treatment. TregGraft (Orca-T) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Subjects with Acute Leukemia or Myelodysplasic Syndrome, Myelofibrosis, or BPDCN
Biological
This is a non-randomized, single-arm study. Patients will be grouped based on their underlying disease: Group 1 will enroll subjects planning to undergo myeloablative allogeneic hematopoietic cell transplantation (MA-alloHCT) for the treatment of either acute myeloid, lymphoid or mixed phenotype leukemia in complete remission (CR) or CR with incomplete hematologic recovery (CRi), and with no known minimal residual disease positivity. Group 2 will enroll subjects Subjects planning to undergo MA-alloHCT for acute myeloid, lymphoid or mixed phenotype leukemia that is either: not in morphologic CR with bone marrow infiltration by leukemic blasts of <= 10%, or in morphologic CR with evidence of minimal residual positivity by either multiparameter flow cytometric analysis or by a nucleic acid-based technique. Group 3 will enroll subjects planning to MA-alloHCT for high or very high risk myelodysplasic syndrome (MDS) myelodysplastic syndromes, myelofibrosis or BPDCN

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 365 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 365 days for reporting.

Closest Location

Winship Cancer Institute - Emory University - Atlanta, GA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
in order to be considered for allogeneic hematopoietic stem cell transplantation (allo-HSCT) If a patient has active acute leukemia (i.e show original
/1.73 m 2 If your estimated glomerular filtration rate (eGFR) is above 50 mL/minute/1.73 m 2 , you are a good candidate for a kidney transplant from a related or unrelated donor. show original
The patient has a resting cardiac ejection fraction of ≥ 45% or a shortening fraction of ≥ 27% as measured by echocardiogram or radionuclide scan (MUGA). show original
acute myeloid, lymphoid or mixed phenotype leukemia
high or very high risk myelodysplastic syndromes
Myelofibrosis
Blastic plasmacytoid dendritic cell neoplasm is a rare type of blood cancer that starts in cells called dendritic cells. show original
The DLCO for carbon monoxide is ≥ 50% for people with hemoglobin. show original
Total bilirubin < 2 times upper limit of normal (ULN) (patients with Gilbert's syndrome may be included where hemolysis has been excluded) and ALT/AST < 3 times ULN
Key

Patient Q&A Section

What is hematologic neoplasms?

"Hematologic neoplasms are neoplasms of the blood or lymphatic system. Causes of death that can be attributed to hematologic neoplasms are [chronic lymphocytic leukemia](https://www.withpower.com/clinical-trials/chronic-lymphocytic-leukemia), chronic myelogenous leukemia, acute myelogenous leukemia, acute lymphocytic leukemia, and multiple myeloma. It is often associated with other neoplasms such as multiple myeloma or breast cancer. Hematologic neoplasms can be divided into leukemia and non-leukemia neoplasms. Non-leukemia neoplasms are often cured by chemotherapy; leukemia neoplasms often require a bone marrow transplant." - Anonymous Online Contributor

Unverified Answer

What causes hematologic neoplasms?

"In the Framingham Heart Study, multiple possible risk factors have been identified. More recent studies have identified at least two risk factors that appear to be related to hematologic neoplasms. The first is a genetically determined tendency towards an increased production of the vitamin, vitamin B12. The second is increased production of the cytokines, TNF-alpha and IL-6, with evidence suggesting both of these factors may be involved in the development of autoimmune diseases. Genetic analysis using the HLA genes suggests that a common genetic factor may predispose to myeloproliferative neoplasms and multiple myeloma." - Anonymous Online Contributor

Unverified Answer

How many people get hematologic neoplasms a year in the United States?

"The number of new diagnoses of malignancies, including hematologic malignancies, has increased dramatically in the past two decades. To monitor and analyze cancer trends, periodic studies are needed." - Anonymous Online Contributor

Unverified Answer

What are common treatments for hematologic neoplasms?

"Common treatment regimens for patients with non-Hodgkin's lymphoma and acute myeloid leukemia comprise surgery, chemotherapy (predominantly anthracycline based regimens or all-trans retinoic acid), and consolidative autologous stem-cell transplantation. Although these agents are effective, treatment is often associated with profound immunosuppression and with side effects that often have significant negative impact on quality of life. In contrast, treatment including allogeneic stem-cell transplantation for patients with chronic myeloid leukemia is the standard of care, and results in long-term survival rates around 85% using the tyrosine-kinase inhibitor imatinib and around 73% using consolidation chemotherapy." - Anonymous Online Contributor

Unverified Answer

Can hematologic neoplasms be cured?

"The survival of patients with hematologic neoplasms is significantly affected by the stage of disease. These data demonstrate that some patients, including children, and young adults, may have a long-term quality of life." - Anonymous Online Contributor

Unverified Answer

What are the signs of hematologic neoplasms?

"Hematological cancers may present with signs and symptoms of unexplained loss of weight. Neoplasm should always be considered in patients with unexplained weight loss on whom" - Anonymous Online Contributor

Unverified Answer

Does hematologic neoplasms run in families?

"Results from a recent clinical trial of this study suggest that hematologic neoplasms and the high percentage of hereditary and heritable factors in these disorders argue for the existence of genetic linkage and/or allelic heterogeneity in families with hematologic neoplasms." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of hematologic neoplasms?

"The global incidence of hematological malignancies has increased dramatically, with the leading cause being infection with a human cytomegalovirus-molecular subtype (CMV-M180). Because the global incidence of CMV-M180 infection is increasing, it is a promising target for developing preventive and therapeutic interventions. On-going research to optimize screening and to reduce transmission of CMV-M180 will hopefully lead to a significant reduction in future cancer incidence due to CMV-M180 infection." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating hematologic neoplasms?

"In the past 15 years, significant improvements in therapy have been made. Potential treatment pathways are detailed and discussed so as to present a more rational means of treatment, even considering chemotherapy. Treatments that use a chemotherapeutic modality that appears to be effective in treatment of hematologic malignancies are discussed by the author." - Anonymous Online Contributor

Unverified Answer

Has treggraft (orca-t) proven to be more effective than a placebo?

"There was no difference on the rate of tumor recurrence between Treggraft and placebo groups, the study had a very low power due to the number of patients and the high variability in treatment for both groups." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for hematologic neoplasms?

"The survival rates for leukemia and non-Hodgkin lymphoma are the lowest reported, and these patients are most likely to be treated with chemotherapy for non-Hodgkin's lymphoma, but because of the relatively good prognosis, this does not significantly change the overall survival. Survival rates for Hodgkin's disease are higher, but because the disease typically presents in children, these treatment types are not commonly used." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for hematologic neoplasms?

"A number of clinical trials were performed as a result of a clinician's request for a clinical trial. These data imply that clinicians may perform clinical trials to improve outcomes. In a recent study, findings also suggest that clinicians may be reluctant to request a clinical trial for a rare disorder for fear of losing patients to the clinical trial." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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