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EX02 CAR-T Cells for Relapsed and Refractory Acute Myeloid Leukemia

NCT06642025 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-10-15

No results posted yet for this study

Summary

This is a early Phase 1 open-label, single-arm clinical study of EX02 CAR-T therapy for relapsed and refractory acute myeloid leukemia.

Each participant will undergo leukapheresis after enrolment, receive treatment of the conditioning chemotherapy of cyclophosphamide and fludarabine, and an an intravenous infusion of CAR-T cells.

Each participant will proceed through the following study procedures:

* Screening
* Enrollment/Leukapheresis
* Conditioning chemotherapy
* CAR T treatment
* Post-treatment assessment
* Long-term follow-up

Conditions

  • Acute Myeloid Leukemia (AML)
  • CAR-T

Interventions

BIOLOGICAL

CAR-T Cell Injection

Conditioning chemotherapy: Lymphodepletion regimen consisting of fludarabine 25 mg/m2/day and cyclophosphamide 250 mg/m2/day for 3 consecutive days, administered 48 hours before intraperitoneal infusion. On the day of administration, premedication with 500mg of acetaminophen orally and 20mg of promethazine intramuscularly or intravenously (or other non-steroidal anti-inflammatory drugs and antihistamines) should be given 30 minutes before intraperitoneal infusion. The therapeutic dose of CAR-T cells is defined as intravenous injection of 1.0E6 CAR-T cells/kg as the initial standard dosage.

Sponsors & Collaborators

  • Zeno Therapeutics Pte. Ltd

    collaborator UNKNOWN

  • Zhimin Zhai

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2026-08-01
Completion
2029-09-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06642025 on ClinicalTrials.gov