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New treatment option for AML, Adult
Official title Natural Killer(NK) Cell Therapy Targeting CLL1 or CD33 in Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT06367673
What this study is testing
What is iPSC-NK cells?
iPSC-NK cells is an investigational medicine, being studied as a potential treatment for aml, adult.
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 is a phase 1, first-in-human (FIH), open-label, multicohort study to evaluate the safety, tolerability and preliminary efficacy of CLL1 or CD33 target Chimeric antigen receptor (CAR) -induced pluripotent stem cells derived NK cells in patients with relapsed/refractory AML
- 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 18 and older
You may be able to join if
- ≥18 years old.
- Confirmed diagnosis of r/r AML
- CLL1 or CD33 expression is positive in AML blasts.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1 and life expectancy greater than 12 weeks.
- Adequate organ and marrow function, as defined below:
You likely can't join if
- Allergic to drug used in this study.
- people received any antitumor therapy as follows, prior to first NK infusion: a. Systemic steroid therapy within 3 days (except physiological...
- History of allogeneic stem cell transplantation.
- Received the vaccine within 4 weeks pror to the first infusion andor expected to reuire vaccination from the study period to 12 weeks ater the last...
- Active central nervous system Leukemia.
- Acute Promyelocytic Leukemia (APL). .History of other malicnant tumors, except for those who have achieved omplete remission more than 5 years after...
See the full eligibility criteria
- ≥18 years old.
- Confirmed diagnosis of r/r AML
- CLL1 or CD33 expression is positive in AML blasts.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1 and life expectancy greater than 12 weeks.
- Adequate organ and marrow function, as defined below:
- Blood creatinine (Cr) ≤ 2 x ULN or calculated creatinine clearance (Cockcroft- Gault formula) ≥ 50 mL/min;
- Total bilirubin (TBIL) ≤ 2 x the ULN;
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN;
- International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN 6.Females of childbearing potential must have a negative serum pregnancy test. 7.Donor specific antibody (DSA) is...
- Allergic to drug used in this study.
- people received any antitumor therapy as follows, prior to first NK infusion: a. Systemic steroid therapy within 3 days (except physiological replacement therapy):b. Systemic antitumor therapy within 2 weeks or at least...
- History of allogeneic stem cell transplantation.
- Received the vaccine within 4 weeks pror to the first infusion andor expected to reuire vaccination from the study period to 12 weeks ater the last intusion
- Active central nervous system Leukemia.
- Acute Promyelocytic Leukemia (APL). .History of other malicnant tumors, except for those who have achieved omplete remission more than 5 years after radical treatment without any sions of recurence9. History of central...
- Active autoimmune diseases.
- Serious cardiovascular and cerebrovascular diseases:a. Severe heart rhythm or conduction abnormalities, corrected OT interval (OTc)\>480 ms:h, Aute coronay sndrome conestve heat faur. aortic disection-stroke. or other...
- Active pulmonary infection: Sp02 90%: Pulmonary embolism, chronic obstructive pulmonary disease, or interstitial lung disease
- Uncontrolled bacterial, fungal, or viral infection.Known HlV infection, active Hepatitis B (HBV) or Hepatitis C (HCV) infection
- Historv of substance abuse.
- Toxicity induced by previous therapy not recovered to s grade 2(NCI-CTCAE 5.0).15. Large suraical treatment within 4 weeks prior to first infusion, not including diagnostic biopsy.16. Pregnant/breastfeeding women.17...
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. 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.