Sequential CD19 and CD22 CAR-T Therapy for Newly Diagnosed Ph- B-ALL

B-Cell Acute Lymphoblastic Leukemia, Adult Clinical Trial

Official title:

Clinical Trial for the Safety and Efficacy of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients With Newly Diagnosed Ph Chromosome Negative B-cell Acute Lymphoblastic Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04740203
• Other study ID #: CD19-005
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 31, 2021
• Est. completion date: January 31, 2025

Study information

• Verified date: February 2021
• Source: Zhejiang University
• Contact: He Huang, PhD
• Phone: 86-13605714822
• Email: hehuangyu[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Clinical Trial for the Safety and Efficacy of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients With Newly Diagnosed Ph Chromosome Negative B-cell Acute Lymphoblastic Leukemia

Description:

This is a prospective, single arm study. To evaluate the safety and efficacy of sequential CD19 and CD22 CAR-T cells in the treatment of adult newly diagnosed Ph chromosome negative B-cell acute lymphoblastic leukemia. The main endpoints were dose limiting toxicity (DLT) and incidence of adverse events (TEAEs).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Age=15 years old

• Newly diagnosed B-cell acute lymphoblastic leukemia according to the 2016 WHO classification

• The immunophenotype of leukemia cells were CD19 and CD22 positive

• Ph- or Ph- like negative

• Anticipated survival time more than 12 weeks;

• Those who voluntarily participated in this trial and provided informed consent.

Exclusion Criteria:

• History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;

• Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;

• Pregnant (or lactating) women;

• Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);

• Active infection of hepatitis B virus or hepatitis C virus;

• Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving inhaled steroids;

• Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;

• Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl;

• Other uncontrolled diseases that were not suitable for this trial;

• Patients with HIV infection;

• Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

Related Conditions & MeSH terms

• B-Cell Acute Lymphoblastic Leukemia, Adult
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• CAR-T cells targeting CD19 and CD22
Each subject receives sequential CD19 and CD22 CAR-T cells by intravenous infusion

Locations

Country	Name	City	State
China	The First Affiliated Hospital, College of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Zhejiang University	Yake Biotechnology Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicity (DLT)	Adverse events assessed according to NCI-CTCAE v5.0 criteria	Baseline up to 28 days after CAR-T cells infusion
Primary	Incidence of treatment-emergent adverse events (TEAEs)	Incidence of treatment-emergent adverse events [Safety and Tolerability]	Up to 2 years after CAR-T cells infusion
Secondary	Complete Remission Rate	Complete Remission Rate after CAR-T cell therapy	up to 28 days after CAR-T cells infusion
Secondary	Overall survival (OS)	From the first infusion of CD19 CAR-T cells to death or the last visit	Up to 2 years after CD19 CAR-T cells infusion
Secondary	Leukemia-free survival (LFS)	From the complete remission to the occurrence of any event, including death, relapse (any one occurs first), and the last visit	Up to 2 years after CD19 CAR-T cells infusion
Secondary	Quality of life	Assessment using European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scale [For item1-28: max score: 112, min score: 28, higher scores mean a better outcome; for item 28-29: max score: 14, min score: 2, higher scores mean a worse outcome] to measure Quality of life at Baseline, Month 1, 3, 6, 9 and 12	At Baseline, Month 1, 3, 6, 9 and 12