Health TrialsbyHealthPanel

Clinical Trial of CD123-targeted CAR-NK Therapy for Relapse/Refractory AML or BPDCN

ConditionsAML (Acute Myeloid Leukemia)BPDCN (Blastic Plasmacytoid Dendritic Cell Neoplasm)
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Anti-CD123 CAR NK cells

    Drug

    Each patient will receive two CAR-NK cell infusions at D0 and D7, and CAR-NK cells need to be controlled within 70 minutes from thawing to infusion completion.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: CD123 CAR-NK cellsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

The incidence of adverse events after CAR-NK cell infusion was assessed by CTCAE, version 5.0.

Time frame
28 dyas
2

Objective response rate (ORR), including complete response (CR) and partial response (PR), after CAR-NK infusion

Time frame
1month, 2 months, 3 months
3

overall survival (OS) after CAR-NK infusion

Time frame
2 years
4

Duration of response (DOR) after CAR-NK infusion

Time frame
2 years

Secondary outcomes

1

Dose limited toxicity (DLT) rate after CAR-NK infusion

Time frame
1 month
2

Cmax of anti-CD123 CAR-NK cells in humans

Time frame
1 month
3

Overall response rate (ORR) after anti-CD123 CAR-NK therapy in relapsed/refractory AML and BPDCN patients

Time frame
1 year
4

Tmax of anti-CD123 CAR-NK cells [Cell dynamics]

Time frame
1 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chongqing Precision Biotech Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
Apply now