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
Not provided
Not provided
Not provided
Not provided
Not provided
This is a single arm, open-label study to evaluate the safety, tolerance and efficacy of CD20 CAR-T Cells in patients with relapsed and refractory B cell non-Hodgkin Lymphoma. Subjects receive a single intravenous infusion of CD20-CART cells per treatment course.
The maximum dose was determined according to the dose escalation test. Based on the number of CART cells per kg body weight which was proved to be safe and effective, all the subjects were treated with one single dose of CD20 CART cells per treatment course. The dose escalation test was designed to evaluate the four dose levels of CD20-CART (1 × 10 ^ 6 cells/kg,2 × 10 ^ 6 cells/kg,4 × 10 ^ 6 cells/kg,8 × 10 ^ 6 cells/kg). Each CD20-CART infusion will be carried out on day 0. Each subject was observed for at least 4 weeks after the last infusion. If there was no dose-limited toxicity (DLT), it is necessary to continue multiple treatment courses at this dose level. The detailed administration time and dose were decided by the researchers. The observation period was 4 weeks after the end of the course of treatment. If 2 or more cases of DLT occurred at a certain dose level, the prior dose level was the maximum tolerable dose of (MTD). If one case of DLT occurred, 3 subjects were added to the group. If there were no DLT in 3 cases, the next dose level would be estimated. If at least 1 case of DLT occurred in the 3 cases, the prior dose was the maximum tolerated dose of (MTD). If there were no DLT at the maximum dose, the maximum tolerant dose was the maximum dose.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD20 CAR-T | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD20 CAR-T | Biological | The maximum dose was determined according to the dose escalation test. Based on the number of CART cells per kg body weight which was proved to be safe and effective, all the subjects were treated with one single dose of CD20 CART cells per treatment course. The dose escalation test was designed to evaluate the four dose levels of CD20-CART (1 × 10 ^ 6 cells/kg,2 × 10 ^ 6 cells/kg,4 × 10 ^ 6 cells/kg,8 × 10 ^ 6 cells/kg). |
| Measure | Description | Time Frame |
|---|---|---|
| The Adverse events (AEs) | Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 | 4 weeks |
| Expression of CD20 CART cells | Expression of CD20 CART cells detected by flow cytometry in blood and bone marrow | 2 years |
| Detection of CD20 CART cells | Detection of CD20 CART cells in blood, bone marrow by Quantitative Polymerase Chain Reaction (q-PCR). | 2 years |
| Graft Activity Endpoint Detection | The vector copy number (VCN) of the exogenous CAR vector in the blood and bone marrow. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall remission rate (ORR) | 2 years | |
| Complete Remission (CR) | 2 years | |
| Partial Remission (PR) |
Not provided
Inclusion Criteria:
1. Patients with CD20+ relapsed or refractory B cell Non-Hodgkin lymphoma, which includes but not limited to diffuse large B cell lymphoma (DLBCL), follicular lymphoma, transformed follicular lymphoma, marginal-zone lymphoma, mantle-cell lymphoma, small B-cell lymphoma, are eligible for inclusion in this study must meet one of the following criteria:
2. Adult subjects between 18 and 70 years of age, inclusive.
3. Life expectancy > 3 months.
4. ECOG score between 0 and 1.
5. Liver, Renal, Heart and Lungs function defined as:
6. According to Lugano 2014 criteria for assessing FDG-PET/CT in lymphoma, the lesions must meet the minimum size requirement of being >15 mm in longest diameter (LDi).
7. Subjects could comprehend the clinical study and able to provide written consent at the time of consent or assent.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tengfeng Ni, Master | Contact | +86 021- 66289710 | nitengfeng@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yi Yao, ph.D | Shanghai Longyao Bio-Tech Co., Ltd. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital with Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210029 | China |
Not provided
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008223 | Lymphoma |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 2 years |
| To evaluate the duration of remission (DOR) | 2 years |
| To evaluate the Progression-free survival (PFS) | 2 years |
| To evaluate the Overall survival (OS) | 2 years |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |