NCT06617572Available不适用
Expanded Access Protocol for Product Which Does Not Conform to the TECELRA® (Afamitresgene Autoleucel, Suspension for Intravenous Infusion) Commercial Release Specification
适应症
试验速览
- 阶段
- 不适用
- 状态
- Available
- 发起方
- USWM CT, LLC
- 试验地点
- 11
研究概览
简要总结
The purpose of this expanded access protocol (EAP) is to provide controlled access to Afamitresgene autoleucel, suspension for intravenous infusion that does not meet the commercial release specification (NC afami-cel). This EAP will be conducted at authorized treatment centers where TECELRA® is being administered and where the EAP is approved to be conducted. Patients who are prescribed TECELRA® , sign the informed consent form, and meet all entry criteria will be eligible to participate in this protocol.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must provide written informed consent prior to participating in this protocol
- •Patient must have been prescribed TECELRA®
- •Patient's commercially manufactured product does not meet the commercial release specification
- •Repeat manufacture is not feasible or is not clinically appropriate per Investigator assessment in consultation with per consultation with USWM CT
- •Repeat leukapheresis is not feasible or is not clinically appropriate per Investigator assessment
- •The Investigator has confirmed a favorable benefit:risk profile, following sponsor evaluation of the NC afami-cel, and deems proceeding with treatment under this EAP is in the best interest of the patient
- •Patient deemed medically fit and stable to receive NC afami-cel per Investigator assessment
- •Female patients with reproductive potential must have a negative serum or urine pregnancy test within 7 days of initiating lymphodepleting chemotherapy
排除标准
- •Patient has contraindication(s) as per the TECELRA® USPI
- •Do not use TECELRA® in adults who are heterozygous or homozygous for HLA-A*02:05P
研究者
研究点 (11)
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