Health TrialsbyHealthPanel

Administration of Anti Tim-3/CD123 CAR-T Cell Therapy in Relapsed and Refractory Acute Myeloid Leukemia (rr/AML)

ConditionsAcute Myeloid Leukemia RefractoryAcute Myeloid Leukemia, in Relapse
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorXuzhou Medical University

About this trial

To evaluate the safety and efficacy of anti Tim3/CD123 CAR-T cells in the treatment of relapsed and refractory acute myeloid leukemia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All subjects must sign and date the Informed Consent before initiating any study specific procedures or activities;

At the age of 18-70 years old;

Diagnosed as relapse/refractory (r/r) de novo or secondary acute myeloid leukemia (AML);

The patient has recovered from the toxicity of previous treatment;

Disqualifiers

Diagnosis of acute promyelocytic leukemia;

History or presence of a CNS disorder;

HBsAg is positive; HCV #HIV or Syphilis antibody are positive, CMV-DNA in peripheral blood is more than≥500 copies /mL;

History of severe hypersensitivity reaction;

Trial design

Design model

Single group

Treatments tested in this trial

  • anti Tim-3/CD123 CAR-T cell therapy

    Drug

    Enrolled patients will receive prespecified dose of autologous CAR-T cells.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: anti Tim-3/CD123 CAR-T cell therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-limiting toxicity #DLT#

Adverse events assessed according to NCI-CTCAE v5.0

Time frame
Baseline up to 28 days after CAR-T cells infusion

Secondary outcomes

1

MRD negative overall response rate (MRD- ORR)

Assessment of MRD negative overall response rate (MRD- ORR) at 3 months of treatment

Time frame
3 months
2

Overall response rate (ORR)

Assessment of ORR (ORR = CR + CRi ) at Month 6, 12, 18 and 24

Time frame
Month 6, 12, 18 and 24
3

Event-free survival (EFS)

Assessment of EFS at Month 6, 12, 18 and 24

Time frame
Month 6, 12, 18 and 24
4

Overall survival (OS)

Assessment of OS at Month 6, 12, 18 and 24

Time frame
Month 6, 12, 18 and 24

Other outcomes

Sponsors and contacts

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

Xuzhou Medical University

Lead sponsor

Source ClinicalTrials.gov
Apply now