Point-of-Care CAR-T Manufacturing Achieves 15-Day Vein-to-Vein Time in Jordan Phase II Trial
核心洞察
King Hussein Cancer Center successfully manufactured 11 anti-CD19 (搜索) CAR-T cell products in-house using the CliniMACS Prodigy (搜索) automated closed system.
Eight patients with relapsed/refractory lymphoma (搜索) were treated under a phase II trial with encouraging responses and no new safety signals.
Average vein-to-vein time was reduced to just over 15 days, demonstrating feasibility of decentralized cell therapy in a developing country.
A team at the King Hussein Cancer Center in Jordan has demonstrated that in-house, point-of-care manufacturing of anti-CD19 CAR-T cells (搜索) is feasible in a developing country, publishing their real-world experience in JCO Global Oncology. Using the CliniMACS Prodigy (搜索) automated closed system, the team successfully manufactured 11 reproducible CAR-T products and treated their first eight patients under a phase II clinical trial, achieving an average vein-to-vein time of just over 15 days with encouraging clinical responses and no new safety signals.
The work addresses a persistent global health equity gap: while CAR-T therapy has transformed outcomes for patients with relapsed/refractory lymphoma (搜索), industry-driven manufacturing remains complex, costly, and slow, keeping it out of reach for much of the world.
A Decentralized Manufacturing Model
Led by first author Khalid Halahleh and senior author Asem Mansour, CEO of King Hussein Cancer Center, the multidisciplinary team asked a straightforward question: "Can we make it here, ourselves, for our own patients? The answer is yes."
The study, titled "Point-of-Care Manufacturing of Anti-CD19 CAR-T Cells (搜索) Using CliniMACS Prodigy (搜索): Real-World Experience From Jordan," details how the center leveraged an automated, closed-system platform to produce CAR-T cell therapies locally. This approach bypasses the logistical and financial barriers associated with centralized, industry-driven manufacturing, which typically requires cryopreservation, international shipping, and extended turnaround times.
Clinical Outcomes and Safety
All eight treated patients had relapsed/refractory lymphoma (搜索). Under the phase II trial protocol, the locally manufactured anti-CD19 (搜索) CAR-T products yielded encouraging responses. Critically, the investigators reported no new safety signals, suggesting that point-of-care manufacturing does not compromise the established safety profile of CD19-directed CAR-T therapy.
The average vein-to-vein time—the interval from leukapheresis to CAR-T infusion—was reduced to just over 15 days. This compares favorably with commercial manufacturing timelines that often extend to three to four weeks or longer, a delay that can be clinically consequential for patients with aggressive disease.
Implications for Global Access
"This is what decentralized, point-of-care cell therapy can look like in a developing country," Mansour stated, expressing deep gratitude to every member of the team who made the achievement possible. The publication demonstrates that academic medical centers in resource-limited settings can build the technical and regulatory infrastructure necessary to deliver cutting-edge cell therapies without relying on multinational commercial supply chains.
The study authors include Khalid Halahleh, Ahmad Abu-Khader, Husam Abu-Jazar, Mohamad Makoseh, Waleed Dana, Rozan Al-Far, Taima' Qabajah, Mohammad Al-Sharairy, Rula Najjar, Ayat Taqash, Yasmin Al Ra'Ee, Mohammad Al-Rawashdeh, Alaa Abu-Fara, Fatena Ajlouni, Walid Naser, Zaid Abdelrahman, Maysa Al-Hussaini, Imad Treish, Hikmat Abdel-Razeq, and Asem Mansour.