CTIS2022-503063-15-00进行中（未招募）1 期
Anti-BCMA chimeric antigen receptor (CARTemis-1) T-lymphocyte therapyin the treatment of patients with multiple myeloma in relapse afterallogeneic transplant: EGFR expression as a control mechanism oftreatment-derived complications - CARTemis-1
Fundacion Publica Andaluza para la Gestion de la Investigacion en Salud de Sevilla (FISEVI)0 个研究点目标入组 25 人开始时间: 2024年2月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •1. Patients > 18 years old with a diagnosis of post-allogeneic transplant relapse multiple myeloma. 2. Medical illness 3. Previous treatment with 2 lines before and/or after allogeneic transplant. 4. Patients who are not receiving immunosuppressants at least 1 month before inclusion and who do not have active GVHD. 5. ECOG functional status from 0 to 1. 6. Life expectancy greater than 3 months 7. Patients who give their consent by signing the Informed Consent document.
排除标准
- •1. Active systemic immunosuppressive therapy. 2. Patients who have previously received CAR-T Anti-BCMA treatment. Patients who have received another type of anti-BCMA therapy will not be excluded, although in this case the positivity for BCMA in myeloma cells must be confirmed at the time of inclusion. 3. Absolute lymphocyte count <0.2x109/L. 4. Previous malignancy, except if in complete remission >3 years, with the exception of cutaneous carcinoma (non-melanoma). 5. Active infection requiring treatment. 6. Active HIV, HBV, or HCV infection. 7. Uncontrolled medical illness. 8. Severe organic disease that meets any of the following criteria: EF <40%, DLCO < 40%, GFR < 50 ml/min, bilirubin > 3 NV (except Gilbert's syndrome). 9. Previous diagnosis of symptomatic AL amyloidosis or POEMS syndrome. 10. Pregnant or lactating women. 11. Women of childbearing potential who are unable or unwilling to use highly effective contraceptive methods 12. Men unable or unwilling to use highly effective contraceptive methods 13. Contraindication to receive lymphodepletive chemotherapy.
研究者
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