Clinical Trial of CD123-targeted CAR-NK Therapy for Relapse/refractory AML or BPDCN
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChongqing Precision Biotech Co., Ltd
About this trial
This is a clincal trial initiated by investigator to evaluate the safety and efficacy of anti-CD123 CAR-NK in the treatment of patients with relapsed/refractory acute myeloid leukemia or blastic plasma cell like dendritic cell tumors.
Eligibility criteria
Qualifiers
Patients of any gender, aged between 18 and 75 years (inclusive);
Positive expression of CD123 on tumor cells detected by flow cytometry;
Relapsed refers to the reappearance of leukemic cells in peripheral blood after complete remission (CR), or ≥5% blasts in bone marrow (excluding other reasons such as bone marrow regeneration after consolidation chemotherapy), or the presence of leukemic cell infiltration outside the marrow;
Refractory refers to patients who have not responded to two courses of standard treatment; patients who have relapsed within 12 months after CR and consolidation/intensification therapy; patients who have relapsed after 12 months but have not responded to conventional chemotherapy; patients with two or more relapses; patients with persistent extramedullary leukemia;
Disqualifiers
Presence of active central nervous system invasion during screening;
Receipt of anti-tumor therapies prior to screening, including chemotherapy, targeted therapy, or other experimental drug treatments within 14 days or at least 5 half-lives (whichever is shorter), except for those who have confirmed disease progression after treatment;
Occurrence of cerebrovascular accident or epileptic seizure within 6 months prior to screening;
Presence of active or uncontrolled infection requiring systemic treatment within 1 week prior to screening;
Trial design
Treatments tested in this trial
- Anti-CD123 CAR NK cells
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov