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Safety and Early Efficacy Study of TBX-2400 in Patients With AML or Myelofibrosis

Study Purpose

This is a study of allogeneic stem cell transplantation with TBX-2400 in adult subjects with Acute Myelogenous Leukemia (AML) or Myelofibrosis (MF). The donor cells are exposed to a protein that has been shown in the laboratory to improve the ability of the donor cells to make blood and immune cells after transplant. Exposure of the donor cells to this protein does not modify the genes in the cells in any way. This study has two goals. The first goal is to find out if transplant with TBX-2400 is safe. The second goal is to find out what effects TBX-2400 stem cells have on time to engraftment in adult subjects with AML or MF. The study hypothesis is that TBX-2400 cells will shorten the time to immune reconstitution after transplant.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. For crAML: AML with ≥5% blasts (either by morphology or by multi-parameter flow cytometry [MFC]) in a marrow aspirate obtained within 21 days of enrollment in the trial, and following the administration of at least two prior courses of chemotherapy; 2. For MF: primary MF or MF that has progressed from a myeloproliferative disease. Dynamic International Prognostic Scoring System (DIPSS)-plus to be utilized to support the inclusion of MF subjects at screening; 3. Subject undergoing allogeneic stem cell transplantation on the decision of transplanting physician; 4. Signed informed consent of donor and recipient; 5. Subjects of ≥ 18 years of age (no upper age limit); 6. Donor agrees to donate bone marrow-derived or mobilized peripheral blood stem cells; 7. Subjects with Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2; 8. Adequate pulmonary function with Diffusing Capacity for Carbon Monoxide (DLCO) > 50; 9. Women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception (e.g. sterilization, hormone implants, hormone injections, intrauterine devices, or vasectomized partner with combined use of condom and/or birth control pills) from screening until 6 months after TBX-2400 transplantation; 10. Able to adhere to all trial treatments and procedures.

Exclusion Criteria:

1. Previous stem cell transplantation; 2. For MF: Blasts > 10% in a marrow aspirate obtained within 30 days of screening; 3. Renal function: serum creatinine > 1.5 x Upper Limit of Normal (ULN); 4. Hepatic function: impaired synthetic function as indicated by a serum fibrinogen below the normal limit. Aspartate transaminase/alanine transaminase (AST/ALT) > 3.0 x ULN. Bilirubin, > 1.5 x ULN; 5. Cardiac function: ejection fraction < 45% as determined by echocardiography; 6. Prior malignancy active within previous three years

- except for locally curable cancers such as cutaneous basal or squamous cell cancer, superficial bladder cancer, carcinoma in situ of cervix or breast, or carcinoma in situ of the prostate; 7.

Positive pregnancy test or breastfeeding for women of childbearing age; 8. Serologic evidence of chronic Hepatitis B virus infection or Hepatitis C exposure; 9. Known history of positive test for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS); 10. Hypersensitivity to any trial medication (including the preparative regimen, TBX-2400 treatment and any prophylaxis or other medication planned); 11. Presence of a serious or uncontrolled medical disorder that, in the opinion of the Investigator, may increase the risk associated with trial participation or trial drug administration, impair the ability of the participant to receive protocol therapy, or interfere with interpretation of trial results.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04709458
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Taiga Biotechnologies, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Andrea Bacigalupo, MD
Principal Investigator Affiliation	Unit for Hematology and BMT, Fondazione Policlinico Universitario Agostino Gemelli, Rome, Italy
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Not yet recruiting
Countries	Croatia, Italy
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Myelofibrosis, Acute Myelogenous Leukemia

Arms & Interventions

Arms

Experimental: TBX-2400 treatment

Single intravenous infusion of TBX-2400

Interventions

Biological: - TBX-2400

Hematopoietic stem cells transplantation

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

University Hospital Centre Zagreb, Zagreb, Croatia

Status

Address

University Hospital Centre Zagreb

Zagreb, , 10000

Site Contact

Nadira Durakovic, MD, PhD

[email protected]

+385-989611829

Roma, Italy