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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
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• 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;

• ECOG score ≤ 2 and expected survival period is not less than 3 months;

• Adequate organ function defined as:AST ≤3×ULN; ALT ≤3×ULN; Total bilirubin ≤1.5×ULN; Serum creatinine ≤1.5×ULN, or CCR≥60 mL/min; Hemoglobin ≥60g/L ; Indoor oxygen saturation ≥92%; LVEF≥45%;

• Pregnancy testing: females of childbearing potential must have a negative serum or urine pregnancy test;

• From the use of study drug to 2 years after treatment, males and female of childbearing potential must agree to use an effective method of contraception.

Locations
Other Locations
China
Kailin Xu
RECRUITING
Xuzhou
Contact Information
Primary
Kailin Xu, MD.,PD.
lihmd@163.com
15162166166
Time Frame
Start Date: 2023-11-04
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 20
Treatments
Experimental: anti Tim-3/CD123 CAR-T cell therapy
Enrolled patients will receive prespecified dose of autologous CAR-T cells.
Related Therapeutic Areas
Sponsors
Leads: Xuzhou Medical University

This content was sourced from clinicaltrials.gov