Safety and Efficacy of CD123-Targeted CAR-T Therapy for Relapsed/Refractory Acute Myeloid Leukemia

NCT04272125 | Unknown Phase 1 DMC

• 1 other identifier: PBC016
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single arm study to evaluate the efficacy and safety of CD123-targeted CAR-T cells therapy for patients with relapsed/refractory Acute Myeloid Leukemia.

Conditions

Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute

Keywords

Leukemia; Acute Myeloid Leukemia; CD123; CAR-T

Outcome Measures

Primary Outcomes (2)

• Adverse events that related to treatment

  Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)

  2 years

• The response rate of CD123 CAR-T treatment in patients with relapse/refractory Acute Myeloid Leukemia that treatment by CD123 CAR-T cells therapy

  The response rate of CD123 CAR-T treatment will be recorded and assessed according to the National Comprehensive Cancer Network Guideline

  6 months

Secondary Outcomes (7)

• Rate of CD123 CAR-T cells in bone marrow and peripheral blood

  2 years

• Quantity of CD123 CAR copies in bone marrow and peripheral blood

  2 years

• Cellular kinetics of CD123 positive cells in bone marrow

  1 years

• Levels of cytokines in serum

  3 months

• Duration of Response (DOR) of CD123 CAR-T treatment in patients with refractory/relapsed acute myeloid leukemia

  2 years

Study Arms (1)

CD123 CAR-T cells treat

EXPERIMENTAL

Patients will be be treated with CD123 CAR-T cells

Biological: CD123 CAR-T cells

Interventions

CD123 CAR-T cells BIOLOGICAL

A single infusion of CD123-CAR-T cells will be administered intravenously

CD123 CAR-T cells treat

Eligibility Criteria

• Age: 3 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent;
• Diagnose as relapsed /refractory acute myeloid leukemia, and meet one of the following conditions:
• Failed to standard chemotherapy regimens;
• Relapse after complete remission, high-risk and / or refractory patients ;
• Relapse after hematopoietic stem cell transplantation;
• Evidence for cell membrane CD123 expression;
• All genders, ages: 3 to 75 years；
• The expect time of survive is above 12 weeks;
• KPS\>60；
• No serious mental disorders ;
• Left ventricular ejection fraction ≥50%
• Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
• Sufficient renal function defined by creatinine clearance≤2 x ULN;
• Sufficient pulmonary function defined by indoor oxygen saturation≥92%;
• With single or venous blood collection standards, and no other cell collection contraindications;

You may not qualify if:

• Have received CAR-T therapy or other genetically modified cell therapy before screening；
• Participated in other clinical research within 1 month before screening；
• Have received the following anti-tumor treatment before screening: Have received chemotherapy, targeted therapy or other experimental drug treatment within 4 weeks, except those who have confirmed disease progression after treatment;
• Live attenuated vaccine within 4 weeks before screening;
• Convulsion or stoke within past 6 months;
• Previous history of other malignancy;
• Presence of uncontrolled active infection;
• Subjects with positive HBsAg or HBcAb positive and peripheral blood HBV DNA titer is higher than the lower limit of detection of the research institution; HCV antibody positive and peripheral blood HCV RNA titer is higher than the lower limit of detection of the research institution; HIV antibody positive; syphilis primary screening antibody positive;
• Pregnant or breasting-feeding women;
• Any situation that investigators regard not suitable for attending in this study or may affect the data analysis.

Sponsors & Collaborators

• Chongqing Precision Biotech Co., Ltd: lead

Study Sites (1)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

RECRUITING

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Cheng Qian, PhD

  Chongqing University Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Ying Xiang, MD

  Chongqing University Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhi Yang, PhD

CONTACT

86-13206140093; yangzhi@precision-biotech.com

Yingzi Zhang

CONTACT

86-18623351275; yingzi6526@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 17, 2020
• Study Start: December 1, 2019
• Primary Completion: December 31, 2023
• Study Completion: July 1, 2024
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

CN (1)