Clinical trial NCT04782193: a Clinical Research of CD19 and CD22 Targeted Prime CAR-T Cell in Relapsed/Refractory B Cell Lymphoma
Official title: Study Evaluating Safety and Efficacy of CD19 and CD22 Targeted Prime CAR-T Cell in Patients With Relapsed/Refractory B Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: B Cell Lymphoma
Keywords: CD19
CD22
CAR-T
Lead sponsor: Chongqing Precision Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-03-04
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 Cell Lymphoma

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 Cell Lymphomato evaluate the efficacy and safety of CD19 and CD22 targeted prime CAR-T cell therapy.

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. Evidence for cell membrane CD19 or CD22 expression
4. All genders ages: 2 to 75 years
5. The expect time of survive is above 3 months;
6. KPS\>60
7. No serious mental disorders ;
8. Left ventricular ejection fraction ≥50%
9. Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
10. Sufficient renal function defined by creatinine clearance≤2 x ULN;
11. Sufficient pulmonary function defined by indoor oxygen saturation≥92%;
12. With single or venous blood collection standards, and no other cell collection contraindications;
13. 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.

Primary outcomes:
measure: Adverse events that related to treatment
timeFrame: 2 years
measure: The response rate of CD19 and CD22 prime CAR-T treatment in patients with relapse/refractory B Cell Lymphoma
timeFrame: 6 months
Secondary outcomes:
measure: Rate of prime CAR-T cells in bone marrow
timeFrame: 2 years
measure: Rate of prime CAR-T cells in peripheral blood
timeFrame: 2 years
measure: Quantity of prime CAR copies in bone marrow
timeFrame: 2 years
measure: Quantity of prime CAR copies in peripheral blood
timeFrame: 2 years
measure: Rate of CD19 and CD22 positive cells in Bone marrow
timeFrame: 1 years
measure: Levels of IL-6 in Serum
timeFrame: 3 months
measure: Levels of IL-10 in Serum
timeFrame: 3 months
measure: Levels of TNF-α in Serum
timeFrame: 3 months
measure: Levels of CRP in Serum
timeFrame: 3 months
measure: Duration of Response (DOR) of CD19 and CD22 prime CAR-T treatment in patients with refractory/relapsed B Cell Lymphoma
timeFrame: 2 years
measure: Progress-free survival(PFS) of CD19 and CD22 targeted prime CAR-T treatment in patients with refractory/relapsed B Cell Lymphoma
timeFrame: 2 years
measure: Overall survival(OS) of CD19 and CD22 prime CAR-T treatment in patients with refractory/relapsed B Cell Lymphoma
timeFrame: 2 years
Other outcomes:
Locations:
city: Kunming
country: China
facility: 920th Hospital of Joint Logistics Support Force
state: Yunnnan
Study officials:
affiliation: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
name: Sanbin Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chongqing University Cancer Hospital
name: Cheng Qian, PhD
role: PRINCIPAL_INVESTIGATOR
References: