CAR-T therapy for high-risk B-ALL patients
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
This study is testing a new treatment combining chemotherapy and CAR-T therapy for adults newly diagnosed with high-risk B-ALL to see if it can improve their outcomes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Soochow University Academic / other |
| Drugs / interventions | CAR-T, chemotherapy |
| Locations | 1 site (Suzhou, Jiangsu) |
| Trial ID | NCT06078306 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of a combination of induction chemotherapy and CD19CD22 CAR-T therapy in adult patients newly diagnosed with high-risk B Acute Lymphoblastic Leukemia (B-ALL). The study employs a prospective, single-arm design, focusing on patients who meet specific criteria related to their leukemia's immunophenotype and risk classification. Participants will receive a regimen that includes Azacitidine and Venetoclax, followed by CAR-T therapy targeting CD19 and CD22 antigens.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with newly diagnosed high-risk B-ALL that is CD19 and CD22 positive.
Not a fit: Patients with severe active infections, previous CAR-T therapy, or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with high-risk B-ALL.
How similar studies have performed: Other studies have shown promise with CAR-T therapies in treating various leukemias, indicating potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Suzhou, Jiangsu
- Xiaowen Tang — Suzhou, Jiangsu, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.