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

NCT05106907 | Unknown Phase 1

• 1 other identifier: FT400-002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

B-cell Malignancy

Outcome Measures

Primary Outcomes (1)

• Treatment related adverse events

  Incidence and severity of adverse events as assessed by NCI-CTCAE 5.0

  90 days post infusion

Secondary Outcomes (4)

• Overall Remission Rate (ORR)

  up to 90 days

• Progression free survival time

  3 years

• Overall survival time

  3 years

• Event-free survival (EFS)

  3 years

Study Arms (1)

ThisCART19 cells injections

EXPERIMENTAL

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.

Biological: ThisCART19 cells

Interventions

ThisCART19 cells BIOLOGICAL

0.2-60 x 10\^6 CAR T cells per kg body weight

ThisCART19 cells injections

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundamenta Therapeutics, Ltd.: lead
• The Affiliated Hospital of Xuzhou Medical University: collaborator

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

RECRUITING

Study Officials

• Zhengyu Li, Ph.D

  The Affiliated Hospital of Xuzhou Medical University

  STUDY CHAIR

Central Study Contacts

Jun Li, Ph.D

CONTACT

18662604088; jli@ctigen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 4, 2021
• Study Start: October 25, 2021
• Primary Completion: October 24, 2023
• Study Completion: October 24, 2024
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

CN (1)