CD19 Targeted Universal Chimeric Antigen Receptor T Cells Injection for CD19+ Refractory/Relapsed B-cell Malignancies

Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia Clinical Trial

Official title:

A Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of Anti-CD19 Universal CAR-T Cells in the Treatment of CD19+ Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia and Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05105867
• Other study ID #: GC011-411
• Status: Recruiting
• Phase: Early Phase 1
• Start date: September 29, 2021
• Est. completion date: November 30, 2024

Study information

• Verified date: April 2023
• Source: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
• Contact: Sanbin Wang, Professor
• Phone: 13187424131
• Email: Sanbin1011[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It is a single-arm, open-label clinical study to assess the safety and efficacy of the Anti-CD19 Universal CAR-T Cells injection for patients with CD19+ refractory/relapsed B cell acute lymphoblastic leukemia and B cell non-Hodgkin lymphoma.

Description:

The study consists of the following periods: screening, lymphodepletion, CAR-T cell infusion, safety follow up, and long term follow-up.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: November 30, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Key Inclusion Criteria:

1. Eastern Cooperative Oncology Group Performance Status of 0 or 1;

2. Expected survival time =12 weeks;

3. Adequate hematological, renal and liver function;

4. Subjects understand and voluntarily sign the informed consent form.

Key Exclusion Criteria:

1. Positive for any of the following etiological tests: HIV, HBV, HCV, TPPA ;

2. Cyclophosphamide or fludarabine is contraindicated for subjects ;

3. Active central nervous system (CNS) involvement by malignancy;

4. Active infection.

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia
• Relapsed or Refractory B-cell Non-hodgkin Lymphoma

Intervention

Biological:
• Anti-CD19 Universal CAR-T Cells injection
Anti-CD19 Universal CAR-T Cells injection will be administered by vein after lymphodepletion.

Locations

Country	Name	City	State
China	920th Hospital of Joint Logistics Support Force of People's Liberation Army of China	Kunming	Yunnan

Sponsors (3)

Lead Sponsor	Collaborator
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China	Gracell Biotechnology Shanghai Co., Ltd., Kunming Hope of Health Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Limiting Toxicities	Incidence of dose-limiting toxicities as protocol-defined	Up to 4 weeks after CAR-T infusion
Secondary	Objective response rate (ORR)	Objective response rate after CAR-T infusion	At 4,12,24 weeks after CAR-T infusion