NCT04156256

Brief Summary

Phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CD123-CD33 cCAR in patients with relapsed and/or refractory, high risk hematologic malignancies.

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
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Mar 2018

Typical duration for early_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

March 1, 2018

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

November 12, 2019

Status Verified

January 1, 2019

Enrollment Period

2.6 years

First QC Date

November 6, 2019

Last Update Submit

November 8, 2019

Conditions

Hematologic MalignancyAcute Myeloid LeukemiaMyelodysplastic SyndromesMyeloproliferative NeoplasmChronic Myeloid Leukemia

Keywords

CD123CD33CD123-CD33 cCARLeukemiaHematologic Malignancies

Outcome Measures

Primary Outcomes (3)

  • Number of participants with dose limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

    28 days

  • Type of dose-limiting toxicity (DLT)

    28 days

  • Number of participants with adverse event by severity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

    2 years

Secondary Outcomes (3)

  • Overall Response Rate (ORR)

    1 year

  • Progression-free survival (PFS)

    1 year

  • Overall survival

    1 year

Study Arms (1)

CD123-CD33 cCAR T cells

EXPERIMENTAL

C123-CD33cCAR T cells transduced with a lentiviral vector to express two distinct units of anti-CD123 and CD33 CARs

Biological: CD123-CD33 cCAR T cells

Interventions

CD123-CD33 cCAR T cellsBIOLOGICAL

CD123-CD33 cCAR T cells transduced with a lentiviral vector to express two distinct units of anti-CD123 and CD33 CARs.

CD123-CD33 cCAR T cells

Eligibility Criteria

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

You may qualify if:

  • Prior HSCT relapse beyond 6 months without active GVHD; systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks
  • De novo AML
  • Transformed AML
  • MDS with excess blasts (RAEB-2)
  • MDS that is not a candidate for induction chemotherapy.
  • Myeloproliferative neoplasms with blastic transformation
  • Patients have exhausted standard therapeutic options

You may not qualify if:

  • Prior solid organ transplantation
  • Potentially curative therapy including hematopoietic cell transplant
  • Prior treatment with CD123xCD3 or CLL1x3 bispecific agents, T cells expressing CD123 CAR or CLL1 CAR, or toxin-conjugated to CD123 or CLL1 antibodies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chengdu Military General Hospital

Chengdu, China

RECRUITING

Peking University Shenzhen Hospital

Shenzhen, China

RECRUITING

MeSH Terms

Conditions

Hematologic NeoplasmsLeukemia, Myeloid, AcuteMyelodysplastic SyndromesMyeloproliferative DisordersLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidNeoplasms by Histologic TypeBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hongyu Zhang, MD, PhD

    Peking University Shenzhen Hospital

    PRINCIPAL INVESTIGATOR

  • Fang Liu, MD, PhD

    Chengdu Military General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin Pinz

CONTACT

6315386218kevin.pinz@icellgene.com

Study Design

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

Study Record Dates

First Submitted

November 6, 2019

First Posted

November 7, 2019

Study Start

March 1, 2018

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

November 12, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)