Trials Sponsors Conditions Drugs Pricing

Conditions

Acute Leukemia Acute Leukemia in Relapse Acute Myeloid Leukemia Relapsed or Refractory Acute Leukemia

Outcome Measures

Primary Outcomes (3)

Dose-limiting toxicity (DLT)
assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
28 days
Incidence of adverse events
assessed by NCI CTCAE version 4.0
Day 1-60 months after injection
Disease response (CR or CRi)
Day 1-60 months after injection

Secondary Outcomes (2)

Survival
Day 1-60 months after injection
Minimal residual disease
Day 1-60 months after injection

Study Arms (1)

anti-CD123 CAR-T treatment

EXPERIMENTAL

Drug: anti-CD123 CAR-T treatment

Interventions

anti-CD123 CAR-T treatmentDrug

Patients receive fludarabine phosphate(300 mg/m\^2) and cyclophosphamide (30 mg/m\^2) IV on days -5 to -3, and then Patients receive autologous anti-CD123 CAR T cells IV over 20 minutes on day 0 (20% of total dose), day2 (30% of total dose) and day6 (50% of total dose, according to the side-effects occured). The total dose of CAR-T cells used in dose-escalation study is 0.5x10\^6- 2.0x10\^6 CAR-T cells/kg.

anti-CD123 CAR-T treatment

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Research patients enrolled are those patients with relapsed or refractory CD123+ acute leukemia (Acute Myeloid Leukemia/ acute lymphoblastic leukemia );
Relapsed: is defined as patients that had a first complete remission (CR) before developing recurrent disease (increased bone marrow blasts);

Sponsors & Collaborators

Nanjing Legend Biotech Co.
Industrycollaborator
Second Affiliated Hospital of Xi'an Jiaotong University
Otherlead

Study Sites (1)

Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710000, China

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteRecurrence

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Ai-Li He, MD, PhD
Second Affiliated Hospital of Xi'an Jiaotong University
PRINCIPAL INVESTIGATOR

Enrollment

2 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

September 13, 2018

First Posted

September 17, 2018

Study Start

April 17, 2019

Actual (reported)

Study Stopped

Study Evaluating Safety and Efficacy of CAR-T Cells Targeting CD123 in Patients With Acute Leukemia

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (2)

Study Arms (1)

anti-CD123 CAR-T treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (2)

Study Arms (1)

anti-CD123 CAR-T treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations