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

NCT06078306 | Unknown Phase 2

• 1 other identifier: High Risk B-ALL
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

B Acute Lymphoblastic Leukemia; Ph-Negative ALL; High Risk Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Complete Remission Rate of VA regime

  The cycle of VA regime is day 21; Effect evaluation was day 7 after VA regime

• Complete Molecular Remission Rate

  The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was day 21 after CD19CD22 cells infusion

• Overall survival (OS)

  The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was 2 years after CD19CD22 CAR-T cells infusion

• Leukemia-free survival (LFS)

  The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was 2 years after CD19CD22 CAR-T cells infusion

Study Arms (1)

CAR-T therapy

EXPERIMENTAL

Therapeutic outcomes in adults with Ph- B-ALL have substantially improved in the last decade, with complete remission (CR) and long-term overall survival (OS) rates of around 90% and 40%-50%, respectively. The presence of measurable residual disease (MRD) is the strongest predictor of relapse in B-ALL. In this study, high risk Ph- B-ALL patients receive the induction chemotherapy with Azacitidine+Venetoclax. After induction chemotherapy with Azacitidine+Venetoclax (VA regime), each subject receives CD19CD22 CAR-T cells by intravenous infusion. The patients with MRD negative will undergo HSCT.

Drug: Azacitidine Injection; Drug: Venetoclax; Drug: CD19CD22 CAR-T

Interventions

Azacitidine Injection DRUG

Azacitidine Injection 75mg/square meter/day, day1-7, subcutaneous injection

Also known as: Azacitidine

CAR-T therapy

Venetoclax DRUG

Venetoclax 100mg day 1, 200mg day 2, 400mg d3-d21, oral

Also known as: ABT-199

CAR-T therapy

CD19CD22 CAR-T DRUG

After induction chemotherapy with Azacitidine+Venetoclax, each subject receives CD19CD22 CAR-T cells by intravenous infusion

Also known as: GDC-0199

CAR-T therapy

Eligibility Criteria

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

You may qualify if:

• Age≥18 and ≤65 years old
• Newly diagnosed and high risk B-ALL according to the 2022 WHO classification
• The immunophenotype of leukemia cells were CD19 and CD22 positive and Ph-;
• Anticipated survival time more than 12 weeks;
• Those who voluntarily participated in this trial and provided informed consent.

You may not qualify if:

• 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);
• Human immunodeficiency virus (HIV) positive; Active infection of hepatitis B virus or hepatitis C virus
• 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;
• Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

Xiaowen Tang

Suzhou, Jiangsu, 215000, China

RECRUITING

MeSH Terms

Conditions

Burkitt Lymphoma

Interventions

Azacitidine; venetoclax

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: October 11, 2023
• Study Start: April 20, 2024
• Primary Completion: September 10, 2024
• Study Completion: September 10, 2025
• Last Updated: April 22, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)