Trials Sponsors Conditions Drugs Pricing

Conditions

Acute Myeloid Leukemia Chronic Myeloid Leukemia Hematologic Malignancy Myelodysplastic Syndromes Myeloproliferative Neoplasm

Keywords

CLL1CD33CLL1-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)

Study Arms (1)

CLL1-CD33 cCAR T cells

EXPERIMENTAL

CLL1-CD33cCAR T cells transduced with a lentiviral vector to express two distinct units of anti-CLL1 and CD33 CARs

Biological: CLL1-CD33 cCAR T cells

Interventions

CLL1-CD33 cCAR T cellsBiological

CLL1-CD33 cCAR T cells transduced with a lentiviral vector to express two distinct units of anti-CLL1 and CD33 CARs.

CLL1-CD33 cCAR T cells

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:

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

Sponsors & Collaborators

iCAR Bio Therapeutics Ltd.
Industrycollaborator
The General Hospital of Western Theater Command
Othercollaborator
Peking University Shenzhen Hospital

Study Sites (2)

The General Hospital of Western Theater Command

Chengdu, China

RECRUITING

Fang Liu, MD, PhDCONTACT

CONTACTlfyh2006@yahoo.com

Peking University Shenzhen Hospital

Shenzhen, China

NOT_YET_RECRUITING

Hongyu Zhang, MD, PhDCONTACT

CONTACTHongyuZhang@pkuszh.com

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 Attributes

Study Officials

Hongyu Zhang, MD, PhD
Peking University Shenzhen Hospital
PRINCIPAL INVESTIGATOR
Fang Liu, MD, PhD
The General Hospital of Western Theater Command
PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin Pinz

CONTACT

6315386218 kevin.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

January 2, 2019

First Posted

January 8, 2019

Study Start

March 1, 2018

Actual (reported)

Primary Completion

September 30, 2022

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

CLL1-CD33 cCAR in Patients With Relapsed and/or Refractory, High Risk Hematologic Malignancies

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (3)

Study Arms (1)

CLL1-CD33 cCAR T cells

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (3)

Study Arms (1)

CLL1-CD33 cCAR T cells

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations