NCT03327285

Brief Summary

This is a single-center, prospective clinical study evaluating safety and efficacy of C-CAR011 treatment in subjects with ALL after HSCT

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

August 17, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 31, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

October 1, 2020

Status Verified

September 1, 2020

Enrollment Period

3 years

First QC Date

August 17, 2017

Last Update Submit

September 30, 2020

Conditions

Acute Lymphoblastic Leukemia(ALL)

Keywords

Acute lymphoblastic leukemiaHematopoietic stem cell transplantationAnti-CD19 chimeric antigen receptor T-cell

Outcome Measures

Primary Outcomes (2)

  • TEAEs

    TEAEs evaluated after C-CAR011 infusion

    2 months

  • GVHD

    GVHD evaluated after C-CAR011 infusion

    2 months

Secondary Outcomes (4)

  • Recurrence rate

    6 and 12 months

  • OS

    12 months

  • PFS

    12 months

  • Remission rate

    2 weeks to 3 months

Study Arms (1)

C-CAR011

EXPERIMENTAL

The amount of cells received：1.0-5.0×10\^6 CAR+T cells/kg

Biological: C-CAR011

Interventions

C-CAR011BIOLOGICAL

CBM.CD19-targeted chimeric antigen receptor T cells(C-CAR011)

Also known as: Anti-CD19 chimeric antigen receptor T cells (C-CAR011)
C-CAR011

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age 15-65 years old, male or female.
  • Volunteered to participate in this study and signed informed consent.
  • Meet the two populations above.
  • Histologically diagnosed as CD19+B-ALL.
  • % T lymphocytes of donor.
  • Treatment without chemotherapy and antibody therapy within 2 weeks prior to C-CAR011 therapy.
  • Left ventricular ejection fraction (LVEF) ≧ 50%, no evidence of pericardial effusion and clinically significant arrhythmias.
  • Baseline oxygen saturation ≧ 92% on room air and with normal pulmonary function, no evidence of active lung infection.
  • Expected survival ≧ 3 months.
  • Eastern cooperative oncology group (ECOG) performance status of 0 or 1.

You may not qualify if:

  • History of allergy to cellular products.
  • Any kind of these laboratory testing: serum total bilirubin≧2.0mg/dl, serum albumin\<35g/L, ALT, AST≧3×ULN, serum creatinine≧2.0mg/ dl,platelets\<20×109/L.
  • The subjects had active aGVHD with II-IV degrees (Glucksberg degrees) or active moderate to severe cGVHD.
  • Severe uncontrolled infection (mycotic, bacterial, virus and so on).
  • Any central nervous system leukemia(CNS2, CNS3) , with insensitive to intrathecal injection of or radiotherapy of head/spine; but effectively controlled cases will be eligible.
  • The subjects were treated CART cells or DLI after HSCT.
  • Bone marrow failure syndrome（BMF） after allogeneic hematopoietic stem cell transplantation.
  • Any genetically modified T cell therapy.
  • History of heavy drinking, drug taking or mental disease.
  • Participated in any other clinical trial within one month prior to enrollment.
  • Women who are pregnant or lactating or have breeding intent in 6 months.
  • The investigators believe that any increase in the risk of the subject or interference with the results of the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Institute of Hematology

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Xiaojun Huang

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single Group Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair

Study Record Dates

First Submitted

August 17, 2017

First Posted

October 31, 2017

Study Start

March 1, 2018

Primary Completion

February 28, 2021

Study Completion

April 30, 2021

Last Updated

October 1, 2020

Record last verified: 2020-09

Locations

CN(1)