Study Evaluating Safety and Efficacy of CD19 and CD22 Targeted Prime CAR-T Cell in Patients with Relapsed/Refractory B-ALL
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Adverse events that related to treatment
Study Overview
Brief Summary
This is a single arm study to evaluate the efficacy and safety of CD19 and CD22 targeted prime CAR-T cells therapy for patients with relapsed/refractory B -ALL
Detailed Description
Although the anti-CD19 CAR-T cell therapies have gained significant results in patients with relapsed and refractory B-cell hematologic malignancies.
There are patients who resisted anti-CD19 CAR-T cells or with CD19 negative relapse. To make further improvement, the investigators launch such a clinical trial using CD19 and CD22 targeted prime CAR-T cells for patients with relapsed and refractory B-ALL to evaluate the efficacy and safety of CD19 and CD22 targeted prime CAR-T cell therapy.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Signed written informed consent
- •Diagnose as Relapsed and Refractory B -ALL, and meet one of the following conditions:
- •Failed to standard chemotherapy regimens;
- •Relapse after complete remission, high-risk and / or refractory patients ;
- •Relapse after hematopoietic stem cell transplantation;
- •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)
- •Evidence for cell membrane CD19 or CD22 expression
- •All genders ages: 2 to 75 years
- •The expect time of survive is above 3 months;
- •No serious mental disorders ;
- •Left ventricular ejection fraction ≥50%
- •Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
- •Sufficient renal function defined by creatinine clearance≤2 x ULN;
- •Sufficient pulmonary function defined by indoor oxygen saturation≥92%;
- •With single or venous blood collection standards, and no other cell collection contraindications;
- •Ability and willingness to adhere to the study visit schedule and all protocol requirements.
Exclusion Criteria
- •Previous history of other malignancy;
- •Presence of uncontrolled active infection;
- •Evidence of disorder that need the treatment by glucocorticoids;
- •Active or chronic GVHD
- •The patients treatment by inhibitor of T cell
- •Pregnant or breasting-feeding women;
- •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.
Arms & Interventions
prime CAR- T cells
Patients will be be treated with CD19 and CD22 prime CAR- T cells
Intervention: CD19 and CD22 targeted prime CAR-T cells (Biological)
Outcomes
Primary Outcomes
Adverse events that related to treatment
Time Frame: 2 years
Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
The response rate of CD19 and CD22 prime CAR-T treatment in patients with relapse/refractory B-ALL
Time Frame: 6 months
The response rate of CD19 and CD22 prime CAR-T treatment will be recorded and assessed according to the National Comprehensive Cancer Network Guideline
Secondary Outcomes
- Levels of TNF-α in Serum(3 months)
- Rate of prime CAR-T cells in bone marrow(2 years)
- Rate of prime CAR-T cells in peripheral blood(2 years)
- Quantity of prime CAR copies in bone marrow(2 years)
- Overall survival(OS) of CD19 and CD22 prime CAR-T treatment in patients with refractory/relapsed B-ALL(2 years)
- Levels of IL-10 in Serum(3 months)
- Quantity of prime CAR copies in peripheral blood(2 years)
- Levels of IL-6 in Serum(3 months)
- Levels of CRP in Serum(3 months)
- Rate of CD19 and CD22 positive cells in Bone marrow(1 years)
- Duration of Response (DOR) of CD19 and CD22 prime CAR-T treatment in patients with refractory/relapsed B-ALL(2 years)
- Progress-free survival(PFS) of CD19 and CD22 targeted prime CAR-T treatment in patients with refractory/relapsed B-ALL(2 years)