OncoMatch/Clinical Trials/NCT06765876
CART123 T Cells in Relapsed or Refractory CD123+ Hematologic Malignancies: A Dose Escalation Phase I Trial
Is NCT06765876 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies Autologous CAR123 T lymphocytes for leukemia, myeloid, acute(aml).
Treatment: Autologous CAR123 T lymphocytes — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Myelodysplastic Syndrome
Biomarker criteria
Required: IL3RA overexpression
CD123 expression on malignant cells confirmed by flow cytometry or by immunohistochemistry
Prior therapy
Must have received: induction chemotherapy — AML
failure to achieve CR or CRi after at least 2 cycles of induction chemotherapy
Must have received: high dose salvage regimen — AML
failure to achieve CR or CRi after ... 1 cycle of high dose salvage regimen
Must have received: venetoclax with azacytidine (venetoclax, azacytidine) — AML
failure to achieve CR or CRi after ... 4 cycles of venetoclax with azacytidine
Must have received: allogeneic hematopoietic stem cell transplantation — AML
Relapse after allogeneic HSCT
Must have received: CAR-T cell therapy (CAR-19 cell therapy) — ALL
disease refractory to or relapsed after CAR-19 cell therapy
Must have received: TKI inhibitor — ALL
CD19 negative relapse ineligible for treatment with TKI inhibitors and inotuzumab ozogamicin
Must have received: inotuzumab ozogamicin (inotuzumab ozogamicin) — ALL
CD19 negative relapse ineligible for treatment with TKI inhibitors and inotuzumab ozogamicin
Must have received: chemotherapy — BPDCN
Refractory or relapsing after chemotherapy with or without allogeneic stem cell transplantation
Must have received: allogeneic hematopoietic stem cell transplantation — BPDCN
Refractory or relapsing after chemotherapy with or without allogeneic stem cell transplantation
Must have received: azacytidine (azacytidine) — MDS-IB2
Disease refractory to at least four cycles of azacytidine or progression on azacytidine-based therapy
Must have received: induction chemotherapy — MDS-IB2
Disease refractory to induction chemotherapy
Must have received: haematopoietic stem cell transplantation — MDS-IB2
Relapse after haematopoietic stem cell transplantation
Cannot have received: allogeneic hematopoietic stem cell transplantation
Allogeneic HSCT within 3 months prior to IMP administration
Lab requirements
Kidney function
Acute kidney injury with serum creatinine > 180 µmol/L, oliguria or need for acute dialysis [excluded]
Liver function
Significant liver impairment: bilirubin > 50 µmol/L, AST or ALT > 4 times normal upper limit [excluded]
Cardiac function
Heart failure with LVEF < 50% by echocardiography [excluded]
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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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