Adult B-ALL Treated by CART Cell Bridging Allogeneic Hematopoietic Stem Cell Transplantation

  • STATUS
    Recruiting
  • End date
    May 30, 2023
  • participants needed
    50
  • sponsor
    Hebei Senlang Biotechnology Inc., Ltd.
Updated on 26 January 2021

Summary

This is an open, single-arm, phase I/phase II clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of Relapsed Refractory (R/R) adult acute lymphoblastic leukemia bridging allogeneic hematopoietic stem cell transplantation.

Description

This trial openly recruited 50 patients into the group and were given CAR-T treatment. Patients participating in clinical trials will be tested and evaluated in terms of treatment safety, efficacy, and response duration. As assessed by clinicians, adult B-ALL patients who meet the enrollment criteria, after adequate communication, the patient or family members voluntarily join the clinical study, and are willing to bridge allogeneic hematopoiesis within 3 months after enrollment using CAR-T therapy

Details
Condition Adult B Acute Lymphoblastic Leukemia
Treatment cyclophosphamide, Fludarabine, CD19 CAR-T, CD22 CAR-T, CD19+CD22 CAR-T
Clinical Study IdentifierNCT04626726
SponsorHebei Senlang Biotechnology Inc., Ltd.
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Be diagnosed a kind of Relapsed or Refractory Haematopoietic and Lymphoid
Malignancies
ECOG score2
To be aged 1 to 65 years
More than a month lifetime from the consent signing date

Exclusion Criteria

Serious cardiac insufficiency, left ventricular ejection fraction<50%
Has a history of severe pulmonary function damaging
Merging other progressing 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)
Has acute GvHD on allogeneic hematopoietic stem cell transplantation patients after stopping immunosuppressants a month
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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