Actively Recruiting
CART123 T Cells in Relapsed or Refractory CD123+ Hematologic Malignancies: A Dose Escalation Phase I Trial
Led by Institute of Hematology and Blood Transfusion, Czech Republic · Updated on 2026-01-12
18
Participants Needed
1
Research Sites
218 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. During the production of CAR123 cells, patients may receive appropriate bridging therapy. After cells are produced, participants will undergo a single course of lymphodepleting chemotherapy and receive a single dose of CAR123 T cells. The trial will establish the recommended dose for further studies, either the Maximum Tolerated Dose (MTD) or Maximum Feasible Dose (MFD). Patients must be eligible for hematopoietic stem cell transplantation in order to participate in the trial.
CONDITIONS
Official Title
CART123 T Cells in Relapsed or Refractory CD123+ Hematologic Malignancies: A Dose Escalation Phase I Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with AML, MDS-IB2, BPDCN, or ALL positive for CD123 antigen meeting specific disease criteria
- For AML: refractory after at least 2 induction cycles, second or later relapse, or relapse after allogeneic HSCT
- For ALL: refractory or relapsed after CAR-19 therapy, or CD19 negative relapse not eligible for certain treatments
- For BPDCN: refractory or relapsing after chemotherapy with or without stem cell transplant
- For MDS-IB2: refractory to azacytidine or induction chemotherapy, or relapse after stem cell transplant
- CD123 expression confirmed by flow cytometry or immunohistochemistry
- Age between 18 and 70 years
- Suitable donor for allogeneic hematopoietic stem cell transplant identified and cleared before treatment
- Able to understand and sign informed consent
- Negative pregnancy test for women of childbearing potential at enrollment and Visit 1
- No available or effective standard-of-care treatments
You will not qualify if you...
- Known allergy to any component of the investigational product
- Allogeneic HSCT within 3 months before treatment
- Severe, uncontrolled active infection
- Life expectancy less than 8 weeks
- Respiratory failure requiring oxygen therapy
- Significant liver impairment (bilirubin > 50 µmol/L, AST or ALT > 4 times normal)
- Acute kidney injury with high creatinine, low urine output, or need for dialysis
- Heart failure with ejection fraction below 50%
- Active severe acute or chronic graft-versus-host disease
- Serious uncontrolled neurological conditions
- Received live virus vaccine within 4 weeks before or 90 days after treatment
- Pregnancy or breastfeeding
- Fertile patients unwilling to use highly effective contraception during the study or those practicing permanent abstinence
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ustav hematologie a krevni transfuze / Institute of Hematology and Blood Transfusion
Prague, Czechia, 12800
Actively Recruiting
Research Team
P
Petr Lesny, MD, PhD
CONTACT
J
Jan Vydra, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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