Safety and Clinical Activity of ThisCART19 in Patients With r/r Non-Hodgkin's B Cell Lymphoma

  • STATUS
    Recruiting
  • End date
    Oct 24, 2024
  • participants needed
    20
  • sponsor
    Fundamenta Therapeutics, Ltd.
Updated on 11 November 2021

Summary

A single arm, open-label, dose-escalation study to evaluate the safety and clinical activity of ThisCART19 (Allogeneic CAR-T targeting CD19) in patients with relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL).

Description

ThisCART19 cell is a non-gene-editing allogeneic CAR-T cell targeting CD19. This study is designed to evaluate the safety and clinical activity of ThisCART19 in patients with CD19 positive, relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL).

Details
Condition B Cell Malignancy
Treatment ThisCART19 cells
Clinical Study IdentifierNCT05106907
SponsorFundamenta Therapeutics, Ltd.
Last Modified on11 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18-70 years old, no gender and race limited
Estimated life expectancy > 12 weeks deemed by investigator
CD19 were positive by histopathology and/or cytology diagnosis
Patients with relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL)
Relevant indicators for disease or assessment within 4 weeks after the last treatment
Quality of Life Score (KPS) >50%
Subject has adequate organ function at screening, cardiac ejection fraction 40%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO); serum ALT/ AST <3 upper limit of normal (ULN); bilirubin<2.0 mg/dl; serum creatinine 1.6 mg/dl and/or BUN 1.5 mg/dl
No remission or relapse after hematopoietic stem cell transplantation or autologous somatic immunotherapy
Unsuitable conditions for stem cell transplantation
Signed informed consent form (ICF)

Exclusion Criteria

Women in pregnancy or lactation
In active infection including hepatitis B, hepatitis C, HIV, or other fatal viral and bacterial infection
The absolute count of nonprimary neutrophil < 0.7510^9/L or platelet count < 5010^9/L
Abnormal vital signs and failure to cooperate with examination
Patients with mental or psychological diseases who cannot cooperate with treatment and efficacy evaluation
Highly allergic constitution or history of severe allergy
Patients with systemic infection or severe local infection requiring anti-infection treatment
Patients with severe autoimmune diseases
Presence of any other conditions that are unsuitable for this study as judged by the investigator
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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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