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New treatment option for Myeloid Malignancies
Official title A Phase I/II Study of CAR.70-Engineered IL15-Transduced Cord Blood-Derived NK Cells With TGF-beta Receptor 2 (TGFBR2) Knock Out in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapsed/Refractory Myeloid Malignancies
ClinicalTrials.gov ID: NCT06930651
What this study is testing
What is Dexamethasone?
Dexamethasone is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for myeloid malignancies.
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
- The goal of this clinical research study is to find the recommended safe dose of TGFBR2 KO CAR27/IL-15 NK cells that can be given to patients with relapsed/refractory disease. The safety and effectiveness of this treatment will also be studied.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Diagnosis: Age 18-80 years with diagnosis of:
- Relapsed or refractory AML or "treated secondary AML"
- Patients with a mutation that is targetable with an FDA-approved targeted therapy should have received at least one on these agents. . "Treated...
- MDS that is intermediate, high-risk or very-high risk by the Revised International Prognostic Scoring System (R-IPSS)
- Bone marrow blasts must be \>5%.
You likely can't join if
- Active grade III-V cardiac failure as defined by the New York Heart Association Criteria
- Active serious infection not controlled by oral or intravenous antibiotics (e.g. persistent fever or lack of improvement despite antimicrobial...
- Active central nervous system leukemia
- Known human immunodeficiency virus (HIV) seropositive, unless well-controlled on stable doses of anti-retroviral therapy.
- Known hepatitis B surface antigen seropositive or known or suspected active hepatitis C infection Note: Patients who have isolated positive hepatitis...
- Patients with a prior or concurrent malignancy whose natural history or treatment is not anticipated to interfere with the safety or how well it...
See the full eligibility criteria
- Diagnosis: Age 18-80 years with diagnosis of:
- Relapsed or refractory AML or "treated secondary AML"
- Patients with a mutation that is targetable with an FDA-approved targeted therapy should have received at least one on these agents. . "Treated secondary AML "includes patients with prior diagnosis of a myeloid neoplasm...
- MDS that is intermediate, high-risk or very-high risk by the Revised International Prognostic Scoring System (R-IPSS)
- Bone marrow blasts must be \>5%.
- The disease must have either 1.) not have responded to at least 4 cycles of a hypomethylating agent or 2.) progressed or relapsed, regardless of the number of cycles received
- CMML-1 or CMML-2
- Bone marrow blasts must be \>5%.
- The disease must have either 1.) not have responded to at least 4 cycles of a hypomethylating agent or 2.) progressed or relapsed, regardless of the number of cycles received
- CD70 expression \>10% measured by immunohistochemistry or multiparameter flow cytometry
- Performance status \</=2 (ECOG Scale)
- Adequate liver, cardiac, renal and pulmonary function as defined by the following criteria:
- Total serum bilirubin \</=2 x upper limit of normal (ULN), unless due to Gilbert's syndrome, hemolysis or the underlying leukemia approved by the PI
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \</=3 x ULN, unless due to the underlying leukemia approved by the PI
- Serum creatinine \ /=30 mL/min
- Left ventricular ejection fraction \>/=40% by echocardiogram or MUGA
- Oxygen saturation \>/=93% on room air
- Ability to understand and the willingness to sign a written informed consent document
- Willingness to sign informed consent to long-term follow-up on protocol PA17-0483 to fulfill institutional responsibilities to regulatory agencies
- Willingness to use adequate contraception prior to study entry, for the duration of study participation, and for 3 months after completion of study participation. For women of childbearing potential, adequate methods of...
- Active grade III-V cardiac failure as defined by the New York Heart Association Criteria
- Active serious infection not controlled by oral or intravenous antibiotics (e.g. persistent fever or lack of improvement despite antimicrobial treatment).
- Active central nervous system leukemia
- Known human immunodeficiency virus (HIV) seropositive, unless well-controlled on stable doses of anti-retroviral therapy.
- Known hepatitis B surface antigen seropositive or known or suspected active hepatitis C infection Note: Patients who have isolated positive hepatitis B core antibody (ie, in the setting of negative hepatitis B surface...
- Patients with a prior or concurrent malignancy whose natural history or treatment is not anticipated to interfere with the safety or how well it works assessment of the investigational regimen may be included only after...
- Use of calcineurin inhibitors (e.g. tacrolimus) within the past 2 weeks
- Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before lymphodepletion, unless full recovery from side effects has occurred or patient has rapidly progressive disease...
- Patients may continue on non-investigational targeted therapies up until 3 days prior to lymphodepletion.
- Pregnant or breastfeeding women will not be eligible
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, 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, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, 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.