An Open and Single Dose-escalation Study to Evaluate the Safety and Clinical Activity of Allogeneic CAR-T Targeting CD22(ThisCART22) in Patients With Relapsed and/or Refractory Non-Hodgkin's B Cell Lymphoma (r/r B-NHL)

Fundamenta Therapeutics, Ltd.1 site in 1 country20 target enrollmentOctober 25, 2021

ConditionsB-cell Malignancy

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: B-cell Malignancy
Sponsor: Fundamenta Therapeutics, Ltd.
Enrollment: 20
Locations: 1
Primary Endpoint: Treatment related adverse events
Status: Recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A single arm, open-label, dose-escalation study to evaluate the safety and clinical activity of ThisCART22 (Allogeneic CAR-T targeting CD22) in patients with relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL).

Detailed Description

ThisCART22 cell is a non-gene-editing allogeneic CAR-T cell targeting CD22. This study is designed to evaluate the safety and clinical activity of ThisCART22 in patients with CD22 positive, relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL).

Registry

clinicaltrials.gov

Start Date

October 25, 2021

End Date

October 25, 2024

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Fundamenta Therapeutics, Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 18-70 years old, no gender and race limited;
•Estimated life expectancy \> 12 weeks deemed by investigator；
•CD22 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 \< 0.75×10\^9/L or platelet count \< 50×10\^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.