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

Phase 1

Recruiting

• Conditions: B-cell Malignancy
• Interventions: Biological: ThisCART19 cells

• Registration Number: NCT05106907
• Lead Sponsor: Fundamenta Therapeutics, Ltd.

Brief 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).

Detailed 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).

Study Timeline

• Status Verified: 2021-10
• Study Start: 2021-10-25
• Study First Submitted: 2021-10-25
• Study First Submitted QC: 2021-10-25
• Last Update Submitted: 2021-10-25
• Study First Posted: 2021-11-04
• Last Update Posted: 2021-11-04
• Primary Completion: 2023-10-24
• Study Completion: 2024-10-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Age 18-70 years old, no gender and race limited;
2. Estimated life expectancy > 12 weeks deemed by investigator；
3. CD19 were positive by histopathology and/or cytology diagnosis；
4. Patients with relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL)；
5. Relevant indicators for disease or assessment within 4 weeks after the last treatment;
6. Quality of Life Score (KPS) >50%；
7. 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;
8. No remission or relapse after hematopoietic stem cell transplantation or autologous somatic immunotherapy;
9. Unsuitable conditions for stem cell transplantation;
10. Signed informed consent form (ICF).

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Exclusion Criteria

1. Women in pregnancy or lactation;
2. In active infection including hepatitis B, hepatitis C, HIV, or other fatal viral and bacterial infection；
3. The absolute count of nonprimary neutrophil < 0.75×10^9/L or platelet count < 50×10^9/L;
4. Abnormal vital signs and failure to cooperate with examination;
5. Patients with mental or psychological diseases who cannot cooperate with treatment and efficacy evaluation;
6. Highly allergic constitution or history of severe allergy;
7. Patients with systemic infection or severe local infection requiring anti-infection treatment;
8. Patients with severe autoimmune diseases;
9. Presence of any other conditions that are unsuitable for this study as judged by the investigator.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ThisCART19 cells injections	ThisCART19 cells	In this study, allogeneic anti-CD19 CAR T Cells(ThisCART19 cells) is used to treat patients with refractory or relapsed CD19 positive B cell malignancies.

Primary Outcome Measures

Name	Time	Method
Treatment related adverse events	90 days post infusion	Incidence and severity of adverse events as assessed by NCI-CTCAE 5.0

Secondary Outcome Measures

Name	Time	Method
Overall survival time	3 years	The interval between administration and death caused by any reason
Progression free survival time	3 years	The interval between administration and disease progression or death
Overall Remission Rate (ORR)	up to 90 days	Anti-tumor efficacy by 2014 Lugano criteria
Event-free survival (EFS)	3 years	EFS is calculated from administration to death, progression of the disease, relapse or gene recurrence, whichever comes first, or last visit.

Trial Locations

Locations (1)

The Affiliated Hospital of Xuzhou Medical University; 🇨🇳 Xuzhou, Jiangsu, China