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| Name | Class |
|---|---|
| Shanghai Changzheng Hospital | OTHER |
| First Affiliated Hospital of Wenzhou Medical University | OTHER |
| The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine | OTHER |
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To evaluate the safety and efficacy of Human BCMA Targeted T Cells Injection for the treatment of BCMA-positive relapsed/refractory multiple myeloma. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of BCMA CAR+ T cells.
Participants with BCMA-positive relapsed/refractory multiple myeloma can participate if all eligibility criteria are met. Tests required to determine eligibility include disease assessments, a physical exam, Electrocardiograph, CT/MRI/PET, and blood draws. Participants receive chemotherapy prior to the infusion of BCMA CAR+ T cells. After the infusion, participants will be followed for side effects and effect of BCMA CAR+ T cells. Study procedures may be performed while hospitalized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Human BCMA targeted T Cells Injection | Experimental | A single infusion of anti-BCMA CAR transduced T cells administered intravenously at a target dose of 3 to 9 x 10^6 CAR T +cells/kg. The classic "3+3" dose escalation will be applied. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human BCMA targeted T Cells Injection | Drug | Autologous genetically modified anti-BCMA CAR transduced T cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by NCI-CTCAE 5.0 | 28 days post infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Anti-BCMA CAR T Cells in blood | 2 years post infusion | |
| Concentration of Anti-BCMA CAR T Cells in bone marrow | 2 years post infusion | |
| Pharmacodynamics (Levels of Cytokines in Serum) |
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Inclusion Criteria:
Subjects volunteer to participate in clinical research, understand and know the research and sign informed consent document, willing to complete all the trial procedures;
18 to 70 Years Old, Male and female;
Expected survival > 12 weeks;
Previously diagnosed as multiple myeloma by IMWG updated criteria (2014);
Patients with positive pathological test results or flow cytometry proving that BCMA expression of malignant plasma cells in bone marrow or plasma cell tumors ≥30%;
One of the following indicators is satisfied:
Patients with relapsed/refractory multiple myeloma. Relapsed is defined as:
Patients have disease progression after at least three-line treatment regimens. Patients previously received at least 3 different mechanisms treatment regimens for multiple myeloma, including protease inhibitors and immunomodulators, and have disease progression within 60 days of the latest treatment ; Refractory is defined as: Patients who achieved remission in the piror therapies, have disease progression within 60 days, or after the latest therapy.
Those who relapse 90 days after stem cell transplantation
ECOG score 0-1;
Liver, kidney and cardiopulmonary functions meet the following requirements:
The venous access required for collection can be established, and no leukocyte collection contraindications.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongliang Fang, doctor | Contact | 021-58552006 | fanghongliang@dashengbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine | Recruiting | Zhengzhou | Henan | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36536403 | Derived | Wang H, Tsao ST, Gu M, Fu C, He F, Li X, Zhang M, Li N, Hu HM. A simple and effective method to purify and activate T cells for successful generation of chimeric antigen receptor T (CAR-T) cells from patients with high monocyte count. J Transl Med. 2022 Dec 19;20(1):608. doi: 10.1186/s12967-022-03833-6. |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| 2 years post infusion |
| Pharmacodynamics (Content of clonal plasma cells in bone marrow) | 2 years post infusion |
| Overall response rate (ORR) after administration | 3 months post infusion |
| Negative proportion of minimal residual disease (MRD) | 28 days post infusion |
| Duration of remission (DOR) after administration | 2 years post infusion |
| Progress Free Survival (PFS) after administration | 2 years post infusion |
| Overall Survival (OS)after administration | 2 years post infusion |
| Positive incidence of anti-drug antibody | 2 years post infusion |
| Shanghai Changzheng Hospital | Recruiting | Shanghai | Shanghai Municipality | 200003 | China |
|
| The First Affiliated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | 325000 | China |
|
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |