Safety and Efficacy of CD19/CD22 Dual Targeted CAR-T Cell Therapy in R/R B-Cell Acute Lymphoblastic Leukemia

  • STATUS
    Recruiting
  • End date
    Nov 21, 2023
  • participants needed
    100
  • sponsor
    Hebei Senlang Biotechnology Inc., Ltd.
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Updated on 21 March 2022
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Summary

This is an open, single-arm, prospective clinical study to evaluate the safety and efficacy of anti CD19 and CD22 CAR-T cell in the treatment of R/R B-ALL.

Description

CD19-directed CAR-T cell therapy has shown promising results in the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia. CD19 and CD22 are proteins usually expressed on the surface of the B leukemia cells. The dual-CARs enables the T-cells to recognize and kill the tumor cell through recognition of CD19 and CD22.

Details
Condition CD19+ and CD 22+ B-ALL
Treatment Cyclophosphamide,Fludarabine, Autologous CD19/CD22 Chimeric Antigen Receptor T-cells
Clinical Study IdentifierNCT05225831
SponsorHebei Senlang Biotechnology Inc., Ltd.
Last Modified on21 March 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Sign the informed consent and be willing and able to comply with the visit, treatment regimen, laboratory examination and other requirements of the study as stipulated in the trial flow chart
A definite diagnosis of B-cell Lymphocyte Leukemia, which meets any of the following criteria: Relapsed : a) relapsed within 12 months after first remission;Refractory: a) no remission after six weeks of induction therapy or no remission after two courses of induction therapy; b) relapsedafter CR for 2 or more times; c) The first relapse after chemotherapy and no remission after at least one salvage treatment; c) relapsed after hematopoietic stem cell transplantation
ECOG Scores: 0~2
CD19 positive and CD22 positive were detected by immunohistochemistry or flow cytometry
Estimated survival time>3 months
Peripheral blood mononuclear immune cells must be collected at least 2 weeks after the last radiotherapy or systemic treatment
For patients with only extramedullary recurrence of B-ALL, there must be at least one assessable lesion

Exclusion Criteria

Serious cardiac insufficiency；
Has a history of severe pulmonary function damaging
Presence of other malignant tumors
Presence of active fungal, bacterial, viral, or other infection requiring IV antibiotics for management
Presence of other severe autoimmune diseases or immunodeficiency disease
Patients with active hepatitis B or hepatitis C([HBVDNA+]or [HCVRNA+])
Known positive serology for human immunodeficiency virus (HIV) or syphilis。
Has a history of serious allergies on biological products (including antibiotics)
Female patients who are under pregnancy and/or lactation, or planing on pregnancy for the next 12 months
Any other situations that the researchers believe will affect the results of the study
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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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