CD19CD22 CAR-T Therapy in Patients With High-Risk B Acute Lymphoblastic Leukemia (B-ALL).

B Acute Lymphoblastic Leukemia Clinical Trial

Official title:

Clinical Trial for the Safety and Efficacy of Induction Chemotherapy With Azacitidine+Venetoclax (VA) and Bridging CD19CD22 CAR-T Therapy in Adult Patients With Newly Diagnosed High-Risk and Ph-negative (Ph-) B-ALL

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06078306
• Other study ID #: High Risk B-ALL
• Status: Recruiting
• Phase: Phase 2
• Start date: April 20, 2024
• Est. completion date: September 10, 2025

Study information

• Verified date: October 2023
• Source: The First Affiliated Hospital of Soochow University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Clinical trial for the safety and efficacy of induction chemotherapy with VA regime and bridging CD19CD22 CAR-T therapy in adult patients with newly diagnosed high-risk and Ph- B-ALL

Description:

To evaluate the safety and efficacy of induction chemotherapy with VA regime and bridging CD19CD22 CAR-T therapy in Adult patients with newly diagnosed high-risk and Ph- B-ALL in this prospective, single arm study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 10, 2025
• Est. primary completion date: September 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age=18 and =65 years old

2. Newly diagnosed and high risk B-ALL according to the 2022 WHO classification

3. The immunophenotype of leukemia cells were CD19 and CD22 positive and Ph-;

4. Anticipated survival time more than 12 weeks;

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

Exclusion Criteria:

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

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

3. Pregnant (or lactating) women;

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

5. Human immunodeficiency virus (HIV) positive; Active infection of hepatitis B virus or hepatitis C virus

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

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

8. Other uncontrolled diseases that were not suitable for this trial;

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Azacitidine Injection
Azacitidine Injection 75mg/square meter/day, day1-7, subcutaneous injection
• Venetoclax
Venetoclax 100mg day 1, 200mg day 2, 400mg d3-d21, oral
• CD19CD22 CAR-T
After induction chemotherapy with Azacitidine+Venetoclax, each subject receives CD19CD22 CAR-T cells by intravenous infusion

Locations

Country	Name	City	State
China	Xiaowen Tang	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Remission Rate	MRD Negative Remission Rate after CD19CD22 cell therapy	The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was day 21 after CD19CD22 cells infusion
Secondary	Complete Remission Rate of VA regime	Complete Remission Rate after VA regime	The cycle of VA regime is day 21; Effect evaluation was day 7 after VA regime
Secondary	Complete Molecular Remission Rate	Complete Molecular Remission Rate after CD19CD22 CAR-T cell therapy	The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was day 21 after CD19CD22 cells infusion
Secondary	Overall survival (OS)	From the first infusion of CD19CD22 cells to death or the last visit	The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was 2 years after CD19CD22 CAR-T cells infusion
Secondary	Leukemia-free survival (LFS)	Up to 2 years after CD19CD22 CAR-T cells infusion	The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was 2 years after CD19CD22 CAR-T cells infusion