Treatment using CD19 and CD22 targeted CAR-T cells for relapsed B-ALL

Study Evaluating Safety and Efficacy of CD19 and CD22 Targeted Prime CAR-T Cell in Patients With Relapsed/Refractory B-ALL

This study is testing a new CAR-T cell treatment that targets both CD19 and CD22 to see if it can help patients with relapsed or hard-to-treat B-cell acute lymphoblastic leukemia feel better.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 2 Years to 75 Years
• Sex: All
• Sponsor: Chongqing Precision Biotech Co., Ltd (Industry-sponsored)
• Drugs / interventions: chemotherapy, CAR-T
• Locations: 1 site (Kunming, Yunnan)
• Trial ID: NCT04781634 on ClinicalTrials.gov

What this trial studies

This clinical research evaluates the safety and efficacy of a novel therapy using CD19 and CD22 targeted prime CAR-T cells in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL). The study aims to address the limitations of existing anti-CD19 CAR-T therapies, particularly for patients who have either not responded to these treatments or have experienced CD19 negative relapses. By focusing on dual targeting, the study seeks to improve treatment outcomes for this challenging patient population.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 2 to 75 with relapsed or refractory B-ALL who have evidence of CD19 or CD22 expression.

Not a fit: Patients who have serious mental disorders or significant cardiac issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with relapsed or refractory B-ALL, potentially improving survival rates.

How similar studies have performed: While CAR-T therapies have shown promise in treating B-ALL, this specific dual-targeting approach is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Signed written informed consent
2. Diagnose as Relapsed and Refractory B -ALL, and meet one of the following conditions:

   1. Failed to standard chemotherapy regimens;
   2. Relapse after complete remission, high-risk and / or refractory patients ;
   3. Relapse after hematopoietic stem cell transplantation;
3. For patients with Ph + ALL, the following conditions must be met: those who have received a standard induction chemotherapy regimen and who have not achieved complete remission after TKI treatment or have relapsed after remission (cannot tolerate TKI treatment or have contraindications to TKI treatment or the presence of TKI class) Except for drug resistant patients)
4. Evidence for cell membrane CD19 or CD22 expression
5. All genders ages: 2 to 75 years
6. The expect time of survive is above 3 months;
7. KPS\>60
8. No serious mental disorders ;
9. Left ventricular ejection fraction ≥50%
10. Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
11. Sufficient renal function defined by creatinine clearance≤2 x ULN;
12. Sufficient pulmonary function defined by indoor oxygen saturation≥92%;
13. With single or venous blood collection standards, and no other cell collection contraindications;
14. Ability and willingness to adhere to the study visit schedule and all protocol requirements.

Exclusion Criteria:

1. Previous history of other malignancy;
2. Presence of uncontrolled active infection;
3. Evidence of disorder that need the treatment by glucocorticoids;
4. Active or chronic GVHD
5. The patients treatment by inhibitor of T cell
6. Pregnant or breasting-feeding women;
7. Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.

Where this trial is running

Kunming, Yunnan

• 920th Hospital of Joint Logistics Support Force — Kunming, Yunnan, China (Recruiting)

Study contacts

• Principal investigator: Sanbin Wang, MD — 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
• Study coordinator: Zhi Yang, PhD

Conditions B-ALL; CD19; CD22; CAR-T