NCT03121625

Brief Summary

This is an open, single-arm, phase I clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of hematopoietic and lymphoid malignancies. A total of 30 patients are planned to be enrolled over a period of 2 years.

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
30

participants targeted

Target at P50-P75 for phase_1 leukemia

Timeline
Completed

Started Dec 2016

Typical duration for phase_1 leukemia

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

December 26, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 20, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

April 25, 2017

Status Verified

April 1, 2017

Enrollment Period

1.9 years

First QC Date

April 17, 2017

Last Update Submit

April 23, 2017

Conditions

LeukemiaLymphoma

Outcome Measures

Primary Outcomes (1)

  • Tumor load

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

    Up to 24 months

Secondary Outcomes (1)

  • CAR T cell persistence

    Up to 24 months]

Study Arms (1)

Autologous CAR-T cells

EXPERIMENTAL

Patients will be be treated with autologous CAR-T cells.

Biological: Autologous CAR-T

Interventions

Autologous CAR-TBIOLOGICAL

Patients will be drawn 50-100 ml blood to obtain enough peripheral blood mononuclear cells (PBMC) for CAR-T manufacturing. The T cells will be purified from the PBMC, transduced with CAR lentiviral vector, expanded in vitro and then frozen for future administration. Chemotherapy will then be given. Following tumor burden reassessment, CAR-T cells will be infused.

Autologous CAR-T cells

Eligibility Criteria

Age1 Year - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The treat history meeting the following criteria:
  • Recurrence of lymphoma patients with imaging (CT/MRI/PET-CT) detection and pathological diagnosis, or recurrence including bone marrow morphology relapse and the MRD recurrence of myeloma patients or leukemia patients, after chemotherapy or stem cell transplantation;
  • Can't get complete remission (including MRD positive) after more than twice repeated chemotherapy of incipient lymphoma, myeloma or leukemia patients;
  • One or twice chemotherapy cannot get remission again (including MRD positive), but not suitable for chemotherapy of incipient lymphoma, myeloma or leukemia patients.
  • \. There is a measurable lesions before treatment at least; 3. ECOG score≤2; 4. To be aged 1 to 70 years; 5. More than a month lifetime from the consent signing date

You may not qualify if:

  • Serious cardiac insufficiency, left ventricular ejection fraction\<50;
  • Has a history of severe pulmonary function damaging;
  • Merging other malignant tumor;
  • Merging uncontrolled infection;
  • Merging the metabolic diseases (except diabetes);
  • Merging severe autoimmune diseases or immunodeficiency disease;
  • patients with active hepatitis B or hepatitis C;
  • patients with HIV infection;
  • Has a history of serious allergies on Biological products (including antibiotics);
  • Happened in 3 \~ 4 acute GvHD after allogeneic hematopoietic stem cell transplantation on recurring patients
  • Pregnancy or lactation women;
  • Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hematology Department, Hebei Medical University Fourth Hospital

Shijiazhuang, Hebei, 050000, China

RECRUITING

MeSH Terms

Conditions

LeukemiaLymphoma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Lihong Liu, PhD & MD

    Hebei Medical University Fourth Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianqiang Li, PhD & MD

CONTACT

008615511369555limmune@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2017

First Posted

April 20, 2017

Study Start

December 26, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2021

Last Updated

April 25, 2017

Record last verified: 2017-04

Locations

CN(1)