NCT02799680

Brief Summary

The purpose of this study is to evaluate the safety and efficiency of allogeneic cluster of differentiation 33 (CD33)-directed chimeric antigen receptor modified T cells (CART-33) infusions in patients with relapsed / refractory acute myeloid leukemia (AML).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2015

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

June 15, 2016

Status Verified

June 1, 2016

Enrollment Period

1.6 years

First QC Date

June 7, 2016

Last Update Submit

June 10, 2016

Conditions

Relapsed and/or Refractory CD33+ AML

Keywords

CARTAML

Outcome Measures

Primary Outcomes (1)

  • Occurrence of study related adverse events

    defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria

    1 year

Secondary Outcomes (3)

  • Overall response rate of allogeneic CART-33

    up to 24 weeks

  • Disease-free survival

    up to 24 weeks

  • Overall survival

    up to 24 weeks

Study Arms (1)

allogeneic CART-33

EXPERIMENTAL

infusions of allogeneic CD33-directed chimeric antigen receptor-modified T cells (CART-33)

Biological: allogeneic CART-33

Interventions

allogeneic CART-33BIOLOGICAL

allogeneic CD33-directed chimeric antigen receptor-modified T cells (CART-33)

allogeneic CART-33

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 50 years
  • Patient with relapsed and/or refractory CD33 positive acute myeloid leukemia (AML)
  • Estimated life expectancy ≥ 12 weeks (according to investigator's judgment)
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

You may not qualify if:

  • Previous treatment with investigational gene or cell therapy medicine products
  • CD33 negative leukemia
  • Any uncontrolled active medical disorder that would preclude participation as outlined
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Affiliated Hospital of Academy of Military Medical Sciences

Beijing, Beijing Municipality, 100071, China

RECRUITING

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Study Officials

  • Huisheng Ai, MD

    Affiliated Hospital of Academy of Military Medical Sciences

    STUDY CHAIR

Central Study Contacts

Huisheng Ai, MD

CONTACT

861066947135

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

June 7, 2016

First Posted

June 15, 2016

Study Start

October 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2018

Last Updated

June 15, 2016

Record last verified: 2016-06

Locations

CN(2)