Not provided
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 |
|---|---|
| Peking University Cancer Hospital & Institute | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
This is a single-centre, single-arm and open-label study to investigate the safety and efficacy of anti CD19/CD22 CAR NK cells in patients with relapsed refractory B cell lymphoma.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-CD19/CD22 CAR NK Cells | Biological | Total dose of 50-600 thousand /kg Anti-CD19/CD22 CAR NK cells will be administered at day0 |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of treatment related adverse events as assessed by CTCAE v4.0 | Defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment. | 1 year |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patients with extramedullary relapse
Burkitt's lymphoma/leukemia
Previously received gene product treatment, anti-CD19/anti-CD3 treatment, or any anti-CD19/CD22 treatment;
Liver and kidney function:
Serological examination:
Active hepatitis B (HBV-DNA > 1000 copies / mL), hepatitis C, or uncontrolled infection
GVHD ≥ 2 or anti-GVHD treatment
IM19 CAR NK cells received allogeneic cell therapy within 6 weeks before infusion, such as donor lymphocyte infusion;
Subject received the most recent treatment (release, chemotherapy, or other) less than 4 weeks
Active CNS disease (tumor cells in CSF, but < 5 WBCs/mL can be included);
Intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation
Creatinine > 1.5 times normal upper limit or ALT / AST > 3 times normal upper limit or bilirubin > 2 times normal upper limit
New York Heart Association (NYHA) graded above or above
Uncontrollable diabetes
Suffering from other uncontrolled diseases, the researchers believe that it is not suitable for joining
Any situation that the investigator believes may increase the risk of the subject or interfere with the test results
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |