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Trial Title:
CD19CD22 CAR-T Therapy in Patients With High-Risk B Acute Lymphoblastic Leukemia (B-ALL).
NCT ID:
NCT06078306
Condition:
B Acute Lymphoblastic Leukemia
Ph-Negative ALL
High Risk Acute Lymphoblastic Leukemia
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Azacitidine
Venetoclax
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Azacitidine Injection
Description:
Azacitidine Injection 75mg/square meter/day, day1-7, subcutaneous injection
Arm group label:
CAR-T therapy
Other name:
Azacitidine
Intervention type:
Drug
Intervention name:
Venetoclax
Description:
Venetoclax 100mg day 1, 200mg day 2, 400mg d3-d21, oral
Arm group label:
CAR-T therapy
Other name:
ABT-199
Intervention type:
Drug
Intervention name:
CD19CD22 CAR-T
Description:
After induction chemotherapy with Azacitidine+Venetoclax, each subject receives CD19CD22
CAR-T cells by intravenous infusion
Arm group label:
CAR-T therapy
Other name:
GDC-0199
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
Detailed 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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Xiaowen Tang
Address:
City:
Suzhou
Zip:
215000
Country:
China
Status:
Recruiting
Contact:
Last name:
xiaowen Tang, phD
Phone:
86-512-67781525
Email:
xwtang1020@163.com
Contact backup:
Last name:
Depei Wu, PhD
Phone:
86-512-67781856
Email:
wudepei@163.com
Start date:
April 20, 2024
Completion date:
September 10, 2025
Lead sponsor:
Agency:
The First Affiliated Hospital of Soochow University
Agency class:
Other
Source:
The First Affiliated Hospital of Soochow University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06078306
