Cord Blood Derived CAR-T Cells in Refractory/Relapsed B Cell Malignancies

March 19, 2019 updated by: Henan Cancer Hospital

Clinical Study of Cord Blood Derived CAR-T Cells in Patients With Refractory/Relapsed B Cell Leukemia/Lymphoma Who Are Failed for Autologous CAR-T Cells or Autologous CAR-T Can Not be Prepared

Evaluation the safety and efficacy of cord blood-derived CAR-T cells in patients with relapsed/refractory B cell leukemia/lymphoma whose disease relapsed after autologous CAR-T cells therapy or who fail to preparation for autologous CAR-T cells

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

CAR-T cells therapy is the preferred option for relapsed/refractory B cell leukemia/lymphoma. However, some patients will relapse after CAR-T cells therapy, and because of previous multicycles chemotherapy it's very difficult to abtain enough lymphocytes for preparation of antologous CAR-T cells. The exploration of alternative source of lymphocytes for CAR-T cells preparation has important clinical implications for such patients. We evaluated the efficacy and safety of cord blood-derived CAR-T cells in such patients, and to explore effective treatment options for such patients.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • Henan Cancer Hospital
      • Zhengzhou, Henan, China
        • Recruiting
        • Henan Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • expected lifespan >3 months
  • patients with refractory/relapsed B cell leukemia/lymphoma whose diseases relapse after autologous CAR-T cells or the preparation for autologous CAR-T cells fails
  • KPS >70
  • for patients with lymphoma, at least one measurable lesion according to RECIST 1.1
  • enough function of heart, liver, kidney and bone marrow
  • no history of severy allergy
  • no other serious diseases that conflict with this plan
  • no other history of malignancy
  • no serious mental illness
  • patients and their families members agree to participate in this clinical study and sign the Informed Consent Form

Exclusion Criteria:

  • pregnant or lactating women
  • vevere infectious or viral diseases
  • active hepatitis B or C viral hepatitis
  • Patients who have used large amounts of glucocorticoids or other immunosuppressive agents within the last 4 weeks
  • participated in other clinical studies in the past 3 months or who have been treated with other gene products;
  • others that other investigators consider not suitable for this clinical study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: experimental arm
cord blood derived CAR T cells group
Biological: CAR-T cells
collecting cord blood for CAR-T cells culture; three days later, FC regimen (fludarabine 30mg/m2/d x 3, cyclophosphamide 600-800mg/m2/d x 2) another two days later, transfusing CAR-T cell with a dose of 0.5-3x106/kg
Other Names:
  • cord blood derived CAR-T cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
occurrence of study related adverse events
Time Frame: one year
safety of CAR-T cells
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objective response rate
Time Frame: three months
the proportion of patients with CR or PR
three months
progression-free survival
Time Frame: one year
from the date of enrollment to the first date of progression detected
one year
overall survival
Time Frame: one year
from the date of enrollment to the date of death
one year
copy number of CAR-T
Time Frame: six months
copy number of CAR-T in blood and bone marrow
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henan Cancer Hospital

Collaborators

Henan Hualong Biotechnology Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 27, 2019

Primary Completion (ANTICIPATED)

January 31, 2021

Study Completion (ANTICIPATED)

January 31, 2022

Study Registration Dates

First Submitted

March 16, 2019

First Submitted That Met QC Criteria

March 16, 2019

First Posted (ACTUAL)

March 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 21, 2019

Last Update Submitted That Met QC Criteria

March 19, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HenanCH CART 2-4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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