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| Name | Class |
|---|---|
| Rui Therapeutics Co., Ltd | INDUSTRY |
| Allorunning Therapeutics | INDUSTRY |
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A single arm, open-label pilot study is designed to determine the safety and efficacy of CD19 and B-cell maturation antigen (BCMA) targeted allogenic CAR-T cells (RN1101) in patients with relapsed/refractory B-cell or plasma cell-derived malignant tumors. 21 patients are planned to be enrolled in the dose-escalation trial. The primary objective of the study is to evaluation of the safety and feasibility of RN1101 for the treatment of relapsed/refractory B-cell or plasma cell-derived malignant tumors. The secondary objective is to evaluate the efficacy of RN1101 for the treatment of relapsed/refractory B-cell or plasma cell-derived malignant tumors. The exploratory objective is to evaluate expansion, persistence and ability of RN1101 to deplete CD19 or BCMA positive cells in patients with relapsed/refractory B-cell or plasma cell-derived malignant tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RN1101 treatment | Experimental | CD19+ or BCMA+ r/r B Cell lymphoma or multiple myeloma (MM) patients to be treated with a single dose of RN1101 cells. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RN1101 injection | Drug | RN1101 injection is an allogenic CAR-T targeted CD19 and BCMA. A single infusion of CAR-T cells will be administered intravenously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events after RN1101 infusion | up to 24 weeks after RN1101 infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of MRD negative patients after RN1101 treatment | 12 weeks, 24 weeks after RN1101 infusion | |
| ORR (PR, VGPR, CR and sCR) of patients receive RN1101 treatment | 12 weeks, 24 weeks after RN1101 infusion |
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Inclusion Criteria:
Exclusion Criteria:
Known allergies, hypersensitivity, intolerance, or contraindications to CD19/BCMA allogenic CAR-T or any components of the trial drugs (including fludarabine, cyclophosphamide, and rituximab), or a history of severe allergic reactions.
Recurrence after allogeneic hematopoietic stem cell transplantation with active graft - versus - host disease (GVHD) requiring steroid or immunosuppressive therapy.
Severe active infection.
Acquired or congenital immunodeficiency.
New York Heart Association (NYHA) Class Ⅲ or Ⅳ heart failure.
History of epilepsy or other central nervous system diseases.
Lymphoma with extranodal involvement of the brain, lungs, or gastrointestinal tract.
Other primary cancers, except:
Systemic high-dose steroids within 2 weeks before treatment.
Pregnant, breastfeeding, or plans to become pregnant within 6 months.
Participation in another clinical trial within the past month.
Any situation the investigator deems may raise risks or interfere with trial results.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoming Fei | Contact | +86-1381512462752 | feixiaomingujs@aliyun.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Jiangsu University | Recruiting | Zhenjiang | Jiangsu | 212001 | China |
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| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Progression free survival after RN1101 treatment | 12 weeks, 24 weeks after RN1101 infusion |
| CAR copies and cell count of CAR-T in blood and bone marrow (if available) after RN1101 treatment | 12 weeks, 24 weeks after RN1101 infusion |
| Duration of response after RN1101 treatment | 12 weeks, 24 weeks after RN1101 infusion |
| Overall survival after RN1101 treatment | 12 weeks, 24 weeks after RN1101 infusion |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |