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

  • STATUS
    Recruiting
  • End date
    Oct 24, 2023
  • participants needed
    30
  • sponsor
    Fundamenta Therapeutics, Ltd.
Updated on 23 March 2022

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 0.2-60 x 10^6 cells per kg body weight.

Details
Condition B Cell Malignancy
Treatment ThisCART19 cells
Clinical Study IdentifierNCT04384393
SponsorFundamenta Therapeutics, Ltd.
Last Modified on23 March 2022

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)
Informed consent explained to, understood by and signed by patient/guardian

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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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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