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Status unknownNCT03564977Updated Jul 2, 2018

CD19-targeted CAR-T Cell Therapy for MRD+ B-cell Malignancies After Autologous Stem Cell Transplantation

An interventional study of CD19-targeted CAR-T cells in Lymphoma, B-Cell, Leukemia, B-Cell and Minimal Disease, Residual, sponsored by Qingdao Central Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-07-02.

Sponsored by Qingdao Central Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The main purpose of this study is to explore the efficacy of CD19-targeted CAR-T cell therapy for minimal residual disease (MRD) in B-cell Malignancies after autologous stem cell transplantation.

Read the detailed description

Relapse is a common cause of failure in patients with B-cell malignancies after autologous stem cell transplantation. CD19-targeted CAR-T cells showed excellent therapeutic efficiency in B-cell malignancies. Investigators attempt to treat minimal residual disease (MRD)-positive B-cell Malignancies after autologous stem cell transplantation by CD19-targeted CAR-T cells and hope to explore the therapeutic effects of CD19-targeted CAR-T cell therapy.

02

Conditions studied

  • Lymphoma, B-Cell
  • Leukemia, B-Cell
  • Minimal Disease, Residual

Keywords

  • CAR-T
  • minimal residual disease
  • B cell maliganacy
03

In context

Neoplasm, Residual

263 studies on the registry are indexed under Neoplasm, Residual; 120 are open to participants now.

This study's planned enrollment of 20 is below the median of 46 across 167 interventional studies indexed under Neoplasm, Residual.

Browse Neoplasm, Residual studies →

Lead sponsor

Qingdao Central Hospital is the lead sponsor of 23 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Confirmed by pathological biopsy in patients with B-cell malignancies and treated by autologous stem cell transplantation.
  2. Age 18 to 75 years old, both male and female;
  3. Is expected to survive more than 3 months;
  4. Physical condition is good: ECOG score≤2;
  5. In group of four weeks before Canon imaging examination evaluation body tumor load, recommend line PET - CT examination.
  6. General requirements autologous as basic, normal blood T lymphocytes in autologous count must >= 0.2 x10\^9 / L;
  7. No obvious abnormal heart, liver, kidney, no large wounds that haven't healed on the body;
  8. Into groups to participate in voluntarily, good adherence, can cooperate test observation, childbearing age women must be 7 days before starting treatment expert pregnancy test and the results were negative, and signed a written informed consent form.

Exclusion criteria

Exclusion Criteria:

  1. Organ failure, such as heart: Class III and IV; liver: to Child grading of liver function grade C; kidney: kidney failure and uremia stage; lung: symptoms of severe respiratory failure; brain: disorder of consciousness;
  2. Existing serious acute infection, uncontrollable, or have fester sex and chronic infection, wound in delay no more;
  3. Patients with significant graft versus host disease (GVHD) after organ transplant history or allogeneic hematopoietic stem cell transplantation;
  4. Systemic autoimmune diseases or immunodeficiency disease, patients with allergic constitution;
  5. Coagulation abnormalities and severe thrombosis;
  6. Pregnancy and lactation women;
  7. Any other chronic disease patients who have been treated with immune agents or hormone therapy;
  8. Patients who have participated in other clinical trials or other clinical trials in the past 30 days;
  9. The Investigator believe the patients should not participate in this experiment.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    CD19-targeted CAR-T cells

    Biological: CD19-targeted CAR-T cells

Interventions

  • BiologicalCD19-targeted CAR-T cells

    MDR+ patients after autologous stem cell transplantation were treated with CD19-targeted CAR-T cells.

06

What researchers measure

Primary outcomes

  1. Objective response rate

    Time frame: 2 years

  2. Disease control rate

    Time frame: 2 years

  3. Overall survival

    Time frame: 2 years

  4. Progress-free survival

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • Qingdao Central Hospital
    Qingdao, Shandong 266042, China
    • Peng Zhao, Dr · Contact · zp8102@126.com
    • Ling Wang, Dr · Contact · wldoctor@126.com
    • Ketao Lan, M.D · Principal investigator
    • Xuezhen Ma, M.D · Sub investigator
    • Ling Wang, M.D · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03564977
Lead sponsor
Qingdao Central Hospital
Collaborators
Yake Biotechnology Ltd.
Responsible party
Sponsor
First posted
Jun 21, 2018
Start date
Jul 15, 2018 (estimated)
Primary completion
Jun 15, 2020 (estimated)
Completion
Jun 15, 2020 (estimated)
Last update
Jul 2, 2018

Study contacts

Peng Zhao, doctor
Contact
zp8102@126.com
8653284961737
Ketao Lana
Contact

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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