Safety and Clinical Activity of ThisCART22 in Patients With r/r Non-Hodgkin's B Cell Lymphoma

Phase 1

Recruiting

• Conditions: B-cell Malignancy
• Interventions: Biological: ThisCART22 cells

• Registration Number: NCT05106946
• Lead Sponsor: Fundamenta Therapeutics, Ltd.

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).

Study Timeline

• Study Start: 2021-10-25
• Study First Submitted: 2021-10-25
• Study First Submitted QC: 2021-10-25
• Status Verified: 2021-11
• Study First Posted: 2021-11-04
• Last Update Submitted: 2021-11-09
• Last Update Posted: 2021-11-11
• Primary Completion: 2023-10-25
• Study Completion: 2024-10-25

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. CD22 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).

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ThisCART22 cells injections	ThisCART22 cells	In this study, allogeneic anti-CD22 CAR T Cells(ThisCART22 cells) is used to treat patients with refractory or relapsed CD22 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
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.
Progression free survival time	3 years	The interval between administration and disease progression or death

Trial Locations

Locations (1)

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