NCT02794961

Brief Summary

CD19 expression on B cell frequently lost after CD19-targeting CAR-T therapy. In present study, we construct a CD22-targeting chimeric antigen receptor to overcome this issue.

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
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

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

June 1, 2016

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 9, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

June 9, 2016

Status Verified

June 1, 2016

Enrollment Period

2 years

First QC Date

June 6, 2016

Last Update Submit

June 6, 2016

Conditions

Recurrent or Refractory B Cell Malignancy

Outcome Measures

Primary Outcomes (1)

  • Complete remission rate

    The B cells in peripheral blood of all enrolled patients will be monitored every week

    12 months

Study Arms (1)

CD22 CAR-T

EXPERIMENTAL

Enrolled patients will receive three escalating doses of autologous CAR-T.

Biological: CD22 CAR-T

Interventions

CD22 CAR-TBIOLOGICAL

Autologous CAR-T cells with average 1\*10\^6 cells/kg body weight

CD22 CAR-T

Eligibility Criteria

Age4 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Greater than four years of age
  • Survival time\>12 weeks
  • B cell hematological malignancies by pathological examination
  • Chemotherapy failure or recurrent B cell malignancy
  • Creatinine\< 2.5mg/dl
  • Glutamic-pyruvic transaminase, glutamic oxalacetic transaminase\< 3 fold of normal level
  • Bilirubin\<2.0mg/dl
  • Karnofsky Performance Status\>50% at the time of screening
  • Adequate pulmonary, renal, hepatic, and cardiac function
  • Fail in autologous or allogenic haemopoietic stem cell transplantation
  • Free of leukocytes removal contraindications
  • Voluntarily join CAR-T clinical trial
  • Understand and sign written informed consent

You may not qualify if:

  • Pregnant or nursing women
  • Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening
  • Feasibility assessment proves that the efficiency of transduction of lymphocyte is below 10% or the lymphocyte cannot be propagated.
  • Abnormal vital signs
  • Highly allergic constitution or history of severe allergies, especially allergy to interleukin-2
  • General infection or local severe infection, or other infection that is not controlled
  • Dysfunction in lung, heart, kidney and brain
  • Severe autoimmune diseases
  • Other symptoms that are not applicable for CAR-T

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated hospital of Xuzhou medical college

Xuzhou, Jiangsu, 221000, China

RECRUITING

Related Publications (1)

  • Haso W, Lee DW, Shah NN, Stetler-Stevenson M, Yuan CM, Pastan IH, Dimitrov DS, Morgan RA, FitzGerald DJ, Barrett DM, Wayne AS, Mackall CL, Orentas RJ. Anti-CD22-chimeric antigen receptors targeting B-cell precursor acute lymphoblastic leukemia. Blood. 2013 Feb 14;121(7):1165-74. doi: 10.1182/blood-2012-06-438002. Epub 2012 Dec 14.

    PMID: 23243285RESULT

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • KaiLin Xu, MD. Ph.D.

    Xuzhou Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiang Cao, M.D., Ph.D.

CONTACT

8651685802291zimu05067@163.com

JunNian Zheng, M.D., Ph.D.

CONTACT

Study Design

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

Study Record Dates

First Submitted

June 6, 2016

First Posted

June 9, 2016

Study Start

June 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2019

Last Updated

June 9, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will share

Locations

CN(1)