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

B-cell Malignancy Clinical Trial

Official title:

An Open and Single Dose-escalation Study to Evaluate the Safety and Clinical Activity of Allogeneic CAR-T Targeting CD19(ThisCART19) in Patients With Relapsed and/or Refractory Non-Hodgkin's B Cell Lymphoma (r/r B-NHL)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05106907
• Other study ID #: FT400-002
• Status: Recruiting
• Phase: Phase 1
• Start date: October 25, 2021
• Est. completion date: October 24, 2024

Study information

• Verified date: October 2021
• Source: Fundamenta Therapeutics, Ltd.
• Contact: Jun Li, Ph.D
• Phone: 18662604088
• Email: jli[@]ctigen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 24, 2024
• Est. primary completion date: October 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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).

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.

Related Conditions & MeSH terms

• B-cell Malignancy
• Lymphoma, B-Cell

Intervention

Biological:
• ThisCART19 cells
0.2-60 x 10^6 CAR T cells per kg body weight

Locations

Country	Name	City	State
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Fundamenta Therapeutics, Ltd.	The Affiliated Hospital of Xuzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment related adverse events	Incidence and severity of adverse events as assessed by NCI-CTCAE 5.0	90 days post infusion
Secondary	Overall Remission Rate (ORR)	Anti-tumor efficacy by 2014 Lugano criteria	up to 90 days
Secondary	Progression free survival time	The interval between administration and disease progression or death	3 years
Secondary	Overall survival time	The interval between administration and death caused by any reason	3 years
Secondary	Event-free survival (EFS)	EFS is calculated from administration to death, progression of the disease, relapse or gene recurrence, whichever comes first, or last visit.	3 years