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 |
|---|---|
| Shanghai Changzheng Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to study the feasibility and efficacy of anti-B-Cell Maturation Antigen (BCMA) expressing T cells in treating patients with multiple myeloma.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anti-BCMA CAR-T | Experimental | Administration of anti-BCMA CAR-T cells to patients with multiple myeloma |
|
| anti-BCMA CAR-T+ Immune inhibitors | Experimental | Administration of anti-BCMA CAR-T cells + Immune inhibitors to patients with multiple myeloma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-BCMA CAR-T cells | Biological | Retroviral vector-transduced autologous T cells to express anti-BCMA CAR |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 5.0 | Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 5.0 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm | Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm | 8 weeks |
| Duration of CAR-positive T cells in circulation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuedong Sun | Contact | 021-58552006 | sunxuedong@dashengbio.com | |
| Weijun Fu | Contact | 021-81885423 | fuweijun2010@hotmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Changzheng Hospital | Recruiting | Shanghai | Shanghai Municipality | 200003 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C024352 | fludarabine |
| D003520 | Cyclophosphamide |
| D000082082 | Immune Checkpoint Inhibitors |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Fludarabine | Drug | 30mg/m2/d |
|
| Cyclophosphamide | Drug | 300mg/m2/d |
|
| Immune inhibitors | Drug | Immune inhibitors |
|
Duration of CAR-positive T cells in circulation |
| 6 months |
| 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 |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |