Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The First Affiliated Hospital of USTC (Anhui Provincial Hospital) | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
This is a single-center, nonrandomized, open-label, study to evaluate the safety and clinical activity of allogeneic CAR-T targeting CD22 in patients with refractory or relapsed CD22-positive B cell malignancies
The patients will receive infusion of ThisCART22 cells from health donor ,to evaluate the safety and efficacy of ThisCART22 Cells in patients with refractory or relapsed CD22-positive B cell malignancies.
In this study, the dose range is 0.2-60 x10^6 cells per kg body weight (no more than 3.0 x 10^9 in total).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ThisCART22 cells injection | Experimental | In this arm,allogeneic anti-CD22 CAR T Cells(ThisCART22 cells) is used to treat patients with refractory or relapsed CD22 positive B cell malignancies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ThisCART22 cells injection | Biological | Assigned Interventions Biological/Vaccine: ThisCART22 cells 0.2-60 x 10^6 CAR-T cells per kg body weight. Intervention study |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of AE or SAE of CART cell infusion in relation to the study drug at grade ≥3 (refer to CTCAE version 4.03); | From infusion to week 12 | |
| ORR (sum of CR and CRi) after infusion. | From infusion to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| The survival time of CAR-T-22 cells in vivo; | From infusion to month 12 | |
| ORR at week 4, 8, and 24 after infusion (ORR4, ORR8, ORR24). | At week 4, 8, and 24 after infusion |
Not provided
Inclusion Criteria:
Subjects who volunteered to participate in the research and signed a written informed consent;
The informed consent was signed between the ages of 3-70, regardless of gender or race;
CD22 positive hematologic malignancies with no alternative treatment options deemed by investigator. including those who are not eligible for allogeneic stem cell transplantation (SCT) due to the following reasons: 3.1 age; 3.2 Concurrent disease; 3.3 Other contraindications, such as contraindications to total body irradiation (TBI) (TBI is one of the important treatment measures before allogeneic stem cell transplantation of ALL); 3.4 Lack of suitable donors; 3.5 Patients with relapse after CD19-CAR T treatment;
Estimated life expectancy > 12 weeks deemed by investigator
Recurrence after any stem cell transplantation (regardless of previous treatment regimen);
Patients who relapse after previous allogeneic SCT (myeloablative or non-myeloablative) and meet all the following entry criteria:
6.1 No active GVHD and no immunosuppression is requiredï¼› 6.2 Transplant for more than 4 monthsï¼›
Serum creatinine ≤1.6 mg/dl and/or BUN ≤ 1.5 mg/dl;
Serum ALT/ AST < 5 upper limit of normal (ULN)ï¼›
Measurable or detectable disease at time of enrollment,include minimal residual disease (MRD) detected by immunotyping, cytogenetics or PCR.
Cardiac ejection fraction ≥ 40%.
Eastern cooperative oncology group (ECOG) performance status of ≤ 2.
Female subjects with fertility have a negative pregnancy test result within 48 hours before the infusion and are not breast-feeding; all subjects with fertility potential before being enrolled in the study and throughout the study period until the last infusion Within 3 months, take adequate contraceptive measures.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xingbing Wang, M.D. | Contact | +8613856007984 | wangxingbing@ustc.edu.cn | |
| Ling He | Contact | +8618626100886 | lhe@ctigen.com |
| Name | Affiliation | Role |
|---|---|---|
| Xingbing Wang, M.D. | The First Affiliated Hospital of USTC (Anhui Provincial Hospital) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of USTC (Anhui Provincial Hospital) | Recruiting | Hefei | Anhui | 230001 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Sequential Assignment
Not provided
Not provided
Not provided
Not provided