NCT04163575

Brief Summary

This study aims to evaluate the safety, efficacy and duration of response of CD22 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in patients with high risk, relapsed CD22+ haematological malignancies.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for phase_1 leukemia

Timeline
Completed

Started Feb 2020

Shorter than P25 for phase_1 leukemia

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

First Submitted

Initial submission to the registry

November 12, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 14, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

December 23, 2019

Status Verified

October 1, 2019

Enrollment Period

1.4 years

First QC Date

November 12, 2019

Last Update Submit

December 20, 2019

Conditions

LeukemiaLymphoma

Keywords

CAR-TLeukemialymphoma

Outcome Measures

Primary Outcomes (4)

  • Adverse events of each patient

    Determine the toxicity profile of the CD22 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0

    3 years

  • Survival time of Anti-CD22 CAR T cells in vivo

    To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood.

    3 years

  • Antitumor Effects

    Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.

    Every 3 months post treatment up to 24 months

  • Maximum tolerated dose (MTD) of CD22 targeted CAR T cells.

    Maximum tolerated dose (MTD) of CD22 targeted CAR T cells.

    4 weeks

Study Arms (3)

experimental:1

EXPERIMENTAL

Acute lymphoblastic leukemia treated with chimeric antigen receptor modified T cells(Anti-CD22-CAR) targeting CD22.

Biological: :Anti-CD22-CAR

experimental:2

EXPERIMENTAL

Chronic lymphoblastic leukemia with chimeric antigen receptor modified T cells(Anti-CD22-CAR) targeting CD22.

Biological: :Anti-CD22-CAR

experimental:3

EXPERIMENTAL

Non-hodgkin lymphoma treated with chimeric antigen receptor modified T cells(Anti-CD22-CAR) targeting CD22.

Biological: :Anti-CD22-CAR

Interventions

:Anti-CD22-CARBIOLOGICAL

Cells extracted, followed by induction chemotherapy before CD22-CAR infusion (dose escalation.)

experimental:1experimental:2experimental:3

Eligibility Criteria

Age2 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Relapsed or refractory B cell derived acute lymphoblastic leukemia(ALL), chronic lymphoblastic leukemia(CLL) and non-hodgkin lymphoma.
  • KPS\>60.
  • Life expectancy\>3 months.
  • Gender unlimited, age from 2 years to 70 years.
  • CD22 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 30% by flow cytometry.
  • Patients who have failed at least one line of a standard treatment.
  • No serious mental disorder.
  • Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of \>94%, and adequate renal function(Cr≤133umol/L).
  • No other serious diseases(autoimmune disease, immunodeficiency etc.).
  • No other tumors.
  • Patients volunteer to participate in the research.
  • Patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to

You may not qualify if:

  • KPS\<50.
  • Patients are allergic to cytokines.
  • Central nervous system leukemia within 28 days.
  • Uncontrolled active infection.
  • Acute or chronic GVHD.
  • Treated with T cell inhibitor.
  • Pregnancy and nursing females.
  • HIV/HBV/HCV Infection.
  • Other situations we think improper for the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

LeukemiaLymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Li xiangqun

    Kecellitics Biotech Company Ltd

    STUDY CHAIR

Central Study Contacts

Li xiangqun

CONTACT

086-15712867910xiangqun_li@doingtimes.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2019

First Posted

November 14, 2019

Study Start

February 1, 2020

Primary Completion

July 1, 2021

Study Completion

July 1, 2022

Last Updated

December 23, 2019

Record last verified: 2019-10