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New treatment option for Leukemia, Myeloid, Acute(AML)
Official title CART123 T Cells in Relapsed or Refractory CD123+ Hematologic Malignancies: A Dose Escalation Phase I Trial
ClinicalTrials.gov ID: NCT06765876
What this study is testing
What is Autologous CAR123 T lymphocytes?
Autologous CAR123 T lymphocytes is an investigational medicine, being studied as a potential treatment for leukemia, myeloid, acute(aml).
Also referred to as CART123, CAR123 T Cells.
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
- Adult patients with refractory or relapsed CD123+ hematologic malignancies, including acute myeloid leukemia, myelodysplastic syndrome, acute lymphoblastic leukemia, or blastic plasmocytoid dentritic cell neoplasm will be recruited in the trial. CART123 cells will be manufatured from blood of each patient.
- 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 to 70
You may be able to join if
- Patients with AML, MDS-IB2, BPDCN or ALL positive for CD123 antigen, who meet one of disease specific criteria below: a) Patients with AML will be...
- CD123 expression on malignant cells confirmed by flow cytometry or by immunohistochemistry.
- Age between 18 and 70 years.
- Patient has a suitable donor for allogeneic hematopoietic stem cell transplantation. Workup and clearance of the donor must be completed before IMP...
- Patient able to understand and sign informed consent.
You likely can't join if
- Known hypersensitivity to any component of the IMP.
- Allogeneic HSCT within 3 months prior to IMP administration.
- Severe, uncontrolled active infection.
- Life expectancy \< 8 weeks.
- Respiratory insufficiency (need for oxygen therapy).
- Significant liver impairment: bilirubin \> 50 µmol/L, AST or ALT \> 4 times normal upper limit.
See the full eligibility criteria
- Patients with AML, MDS-IB2, BPDCN or ALL positive for CD123 antigen, who meet one of disease specific criteria below: a) Patients with AML will be eligible if they meet one of the following criteria: i) Patient with...
- CD123 expression on malignant cells confirmed by flow cytometry or by immunohistochemistry.
- Age between 18 and 70 years.
- Patient has a suitable donor for allogeneic hematopoietic stem cell transplantation. Workup and clearance of the donor must be completed before IMP administration.
- Patient able to understand and sign informed consent.
- Women of child-bearing potential: negative pregnancy test at enrolment (PSV) and at Visit 1.
- Patient for whom there are no standard-of-care treatments available or such treatment options have been exhausted.
- Known hypersensitivity to any component of the IMP.
- Allogeneic HSCT within 3 months prior to IMP administration.
- Severe, uncontrolled active infection.
- Life expectancy \< 8 weeks.
- Respiratory insufficiency (need for oxygen therapy).
- Significant liver impairment: bilirubin \> 50 µmol/L, AST or ALT \> 4 times normal upper limit.
- Acute kidney injury with serum creatinine \> 180 µmol/L, oliguria or need for acute dialysis.
- Heart failure with LVEF \< 50% by echocardiography.
- Presence of active grade 3 - 4 acute GvHD or severe chronic GvHD.
- Serious uncontrolled neurological comorbidity.
- Vaccination with live virus vaccines in the 4 weeks before IMP administration and within 90 days after the IMP dose.
- Women: pregnancy or breast-feeding.
- people of fertile age, unless permanent sexual abstinence is their lifestyle choice:
- female patients of childbearing potential not willing to use a highly effective method of contraception during the study,
- male patients whose sexual partner(s) are women of childbearing potential who are not willing to use a highly effective method of contraception during the study.
The study team makes the final eligibility decision.
Where it's taking place
- Prague, Czechia
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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Prague, Czechia. 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.