BridgeMD
New treatment option for Acute Myeloid Leukemia, in Relapse
Official title Off-the-shelf CD123 CAR-NK for R/R AML
ClinicalTrials.gov ID: NCT06201247
What this study is testing
What is JD123 injection?
JD123 injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute myeloid leukemia, in relapse.
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 single-centre, single-arm, open-label, first-in-human (FIH) study to evaluate the safety, tolerability and preliminary efficacy of universal Off-the-shelf CAR-NK cells targeted CD123 (JD123 injection) in the treatment of refractory or relapsed CD123-positive acute myeloid leukemia (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
- Age ≥ 18 years old, no gender or race;
- Expected survival period ≥ 3 months;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;
- The diagnosis of AML with bone marrow biopsy, immunohistochemistry or Flow cytometry definitively positive for CD123 and met the following criteria...
- Adequate organ function: A. Liver function: ALT≤3×ULN, AST≤3×ULN, total bilirubin≤2×ULN; B. Coagulation function: international normalized ratio...
You likely can't join if
- Active Central nervous system leukemia;
- Known contraindication to the protocol defined lymphodepleting chemotherapy regimen of fludarabine/cyclophosphamide;
- Systemic use of hormones within 4 weeks prior to enrollment (except for patients with inhaled corticosteroids);
- Any active infection requiring systemic therapy by intravenous infusion within 14 days prior to the first dose of study drug, including: HBV, HCV...
- History of hypersensitivity reactions to murine protein-containing products, or macromolecular biopharmaceuticals such as antibodies or cytokines;
- Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 years after enrollment;
See the full eligibility criteria
- Age ≥ 18 years old, no gender or race;
- Expected survival period ≥ 3 months;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;
- The diagnosis of AML with bone marrow biopsy, immunohistochemistry or Flow cytometry definitively positive for CD123 and met the following criteria: A. Diagnostic criteria for relapsed AML: after complete remission...
- Adequate organ function: A. Liver function: ALT≤3×ULN, AST≤3×ULN, total bilirubin≤2×ULN; B. Coagulation function: international normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤ 1.5×ULN; C. Renal...
- Active Central nervous system leukemia;
- Known contraindication to the protocol defined lymphodepleting chemotherapy regimen of fludarabine/cyclophosphamide;
- Systemic use of hormones within 4 weeks prior to enrollment (except for patients with inhaled corticosteroids);
- Any active infection requiring systemic therapy by intravenous infusion within 14 days prior to the first dose of study drug, including: HBV, HCV, HIV, syphilis infection, or active pulmonary tuberculosis.
- History of hypersensitivity reactions to murine protein-containing products, or macromolecular biopharmaceuticals such as antibodies or cytokines;
- Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 years after enrollment;
- Women who are pregnant (urine/blood pregnancy test positive) or lactating;
- Suffering from a serious autoimmune disease or immunodeficiency disease; 9 Suffering from mental illness; 10\. Known alcohol dependence or drug dependence; 11. According to the investigator's judgment, the patient has...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, 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 Beijing, Beijing Municipality, 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.