Safety and Efficacy of ThisCART19 in Patients With Refractory or Relapsed B Cell Malignancies

  • STATUS
    Recruiting
  • participants needed
    30
  • sponsor
    Fundamenta Therapeutics, Ltd.
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Updated on 19 February 2024
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Summary

This is a study to evaluate the safety and clinical activity of ThisCART19 (Allogeneic CAR-T targeting CD19) in patients with refractory or relapsed CD19 positive B cell malignancies.

Description

This is a single-center, nonrandomized, open-label study to evaluate the safety and clinical activity of ThisCART19 in patients with refractory or relapsed CD19 positive B cell malignancies, such as acute or chronic lymphocytic leukemia, lymphoma and etc. The dose range is 0.2-6 x 10^6 cells per kg body weight.

Details
Condition B Cell Malignancy
Age 3years - 70years
Treatment ThisCART19 cells
Clinical Study IdentifierNCT04384393
SponsorFundamenta Therapeutics, Ltd.
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Patient with relapsed or refractory CD19 positive acute or chronic lymphocytic leukemia, or lymphoma
No alternative treatment options deemed by investigator
Measurable or detectble disease at time of enrollment
Eastern cooperative oncology group (ECOG) performance status of 2
Cardiac ejection fraction 40%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO)
Estimated life expectancy > 12 weeks deemed by investigator
Serum creatinine 1.6 mg/dl and/or blood urea nitrogen(BUN) 1.5 mg/dl
Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 5 upper limit of normal (ULN)

Exclusion Criteria

Pregnant or lactating women
Uncontrolled infection
Active hepatitis B virus or hepatitis C virus infection
Patients who need steroids to control disease
Patients who accepted autologous stem-cell transplantation (ASCT) within 100 days
Patients with grade 2-4 graft-versus-host disease (GVHD), or deemed need to manage by investigator
History of Human Immunodeficiency Virus (HIV) infection
Patients with active central nervous system (CNS) involvement by malignancy
Patients combine with other disease cause neutrophil count (ANC) < 750 per microlitre or platelet count (PLT)< 50,000 per microlitre
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2 study centers available

    Anhui Provincial Hospital, Anhui Medical University

    China

    Fundamenta Therapeutice Co.,Ltd

    China

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Anhui Provincial Hospital, Anhui Medical University

China

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