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

Sponsor
The First Affiliated Hospital of Soochow University
Study ID
NCT06078306
Phase
PHASE2
Status
Unknown

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Apr 20, 2024
Status verified
Oct 2023
Primary completion
Sep 10, 2024
Completion
Sep 10, 2025

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CAR-T therapy
    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.

Primary Outcome Measure

Complete Remission Rate [ Time Frame: The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was day 21 after CD19CD22 cells infusion ]

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