NCT04094766

Brief Summary

This is a single arm, open-label, dose escalation clinical study to evaluate the safety and efficacy of infusion of dual specificity CD19 and CD22 CAR-T cells in patients with relapsed and refractory acute B lymphoblastic leukemia.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2017

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

Enrollment Period

3.1 years

First QC Date

September 17, 2019

Last Update Submit

November 3, 2020

Conditions

Refractory B Acute Lymphoblastic LeukemiaRelapse B Acute Lymphoblastic Leukemia

Keywords

Chimeric Antigen Receptor T cellsCD19 and CD22

Outcome Measures

Primary Outcomes (1)

  • Occurrence of treatment related adverse events

    Assessed by CTCAE v4.0

    Day 1-100 days after injection

Secondary Outcomes (3)

  • Objective response rate

    Day 1-5 years after injection

  • Overall survival

    Day 1-5 years after injection

  • Progression free survival

    Day 1-5 years after injection

Other Outcomes (1)

  • Copy numbers of CAR-T cells in patients

    Day 1-5 years after injection

Study Arms (1)

BLLCAR-L10D treatment group

EXPERIMENTAL

In BLLCAR-L10D treatment group, patients will be treated with dual specificity CD19 and CD22 CAR-T cells with a escalation approach, 3 CAR-T dosage will be tested in this study: 0.5×10\^6, 1.5×10\^6, 2.0×10\^6 CAR-T cells/kg.

Drug: Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy

Interventions

Dual Specificity CD19 and CD22 CAR-T Cell ImmunotherapyDRUG

Patients will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of CAR-T cells. After a pre-treatment lymphodepletion therapy, patients will receive the Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy by intravenous injection.

BLLCAR-L10D treatment group

Eligibility Criteria

Age14 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Written informed consent could be acquired;
  • Diagnosed with relapse/refractory acute lymphoblastic leukemia;
  • Relapse was defined as recurrence of blast cell(more than 5%) in peripheral blood or in bone marrow or extramedullary involvement;
  • Refractory was defined as failed to achieve complete remission after two courses of induction therapy;
  • CD19/CD22 postive leukemia cell was confirmed by flow cytometry or immunohistochemistry within 90 days since enrollment in this trial;
  • Karnofsky score ≥70;
  • Results of pregnant test should be negative, and agree to conception control during treatment and 6 months after CAR-T infusion.
  • Adequate organ function: EF≥50%; normal ECG; CCR ≥ 50ml/min or Cr \< 2.0mg/dL or \< 2 times upper limitation of normal; ALT and AST\<5 times upper limitation of normal; Serum bilirubin ≤ 3.0mg/dL; DLCO or FEV1 \> 45% of predict value;
  • At least 2 weeks intervals since the last chemotherapy;
  • At least 2 weeks intervals since the last anti-GVHD therapy if patients have ever ;

You may not qualify if:

  • Patients diagnosed with acute promyelocytic leukemia:t(15;17)(q22;q12);
  • Women in pregnancy and lactation;
  • Uncontrolled infection, Active HBV or HCV infection, HIV positive or any other deadly bacterial/virual diseases;
  • Long term use of systemic corticosteroids(5mg per day for 2 weeks);
  • Any other uncontrolled life-threaten diseases;
  • Patients with history of anaphylaxis to any drugs;
  • With central nervous system (CNS) involvement;
  • Patients with GVHD after allo-HSCT who needed immunosuppressive agents ;
  • Patients with acute autoimmune diseases such as psoriasis or rheumatoid arthritis;
  • Other conditions that principle investigator considered may increase the risk of the patients or interference the results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710000, China

Location

MeSH Terms

Conditions

Burkitt Lymphoma

Condition Hierarchy (Ancestors)

Epstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Aili He, MD, PhD

    Second Affiliated Hospital of Xi'an Jiaotong University

    PRINCIPAL INVESTIGATOR
0

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

September 17, 2019

First Posted

September 19, 2019

Study Start

August 1, 2017

Primary Completion

August 30, 2020

Study Completion

August 30, 2020

Last Updated

November 5, 2020

Record last verified: 2020-11

Locations

CN(1)