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The pivotal study of the second CAR-T cell product approved for adult lymphoma, which put about a third of people with no remaining options into a lasting remission.
JULIET was the international single-arm registration study of tisagenlecleucel, an autologous CD19-directed chimeric antigen receptor T-cell product, in adults with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of therapy or after a failed autologous transplant. It ran in parallel with ZUMA-1 and used a cryopreserved apheresis product and a centralised manufacturing network, which is why its logistics, not only its biology, were studied.
The trial is in the corpus as its publication (paper-juliet-tisagenlecleucel-dlbcl-nejm-2019); the record here exists so the registry id and the study's place in the sequence have a page. Its practical importance is that it, ZUMA-1 and TRANSCEND NHL 001 together converted CAR-T from an experiment into a third line of treatment, and that the differences between their eligibility rules, bridging policies and manufacturing times explain much of the difference between their headline numbers. JULIET allowed bridging therapy and cryopreserved product; ZUMA-1 did not allow bridging.
The later randomised second-line trials split on exactly this axis. BELINDA, which tested tisagenlecleucel against salvage chemotherapy and transplant, was negative; ZUMA-7 and TRANSFORM, testing the other two products, were positive.
The reason second-line CAR-T is offered with axicabtagene ciloleucel or lisocabtagene maraleucel rather than tisagenlecleucel. The trial is also the strongest evidence in the field that the interval between apheresis and infusion, and what is given during it, is part of the treatment rather than logistics around it.
JULIET, with ZUMA-1, showed that CAR-T could rescue a substantial minority of adults with chemotherapy-refractory lymphoma and that complete responders often stay in remission. The lower toxicity of a 4-1BB construct and the option of bridging therapy made it usable in a broader population. The high drop-out between enrolment and infusion remains a lesson about turnaround time.
Shares Bridging therapy, Lymphodepletion before CAR-T, BELINDA, TRANSFORM and the tag lymphoma-evidence.
Shares The CAR-T pathway in lymphoma: referral, apheresis, bridging and the waiting, Tisagenlecleucel, ICANS (neurotoxicity), Cytokine release syndrome (CRS) and the tag lymphoma-evidence.
Shares TRANSFORM, TRANSCEND NHL 001, ICANS (neurotoxicity), Cytokine release syndrome (CRS) and the tag lymphoma-evidence.
Shares Tisagenlecleucel, ICANS (neurotoxicity), Cytokine release syndrome (CRS), Manufacturing cost and time for living and radioactive medicines and the tag lymphoma-evidence.
Shares Lymphodepletion before CAR-T, ICANS (neurotoxicity), Cytokine release syndrome (CRS), Manufacturing cost and time for living and radioactive medicines and the tag lymphoma-evidence.
Shares Cytokine release syndrome (CRS), Manufacturing cost and time for living and radioactive medicines, Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting, Most of the world has almost no cancer care and the tag lymphoma-evidence.
Shares Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting, Most of the world has almost no cancer care, Diffuse large B-cell lymphoma, Non-Hodgkin lymphoma (all types) and the tag lymphoma-evidence.
Shares Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting, Most of the world has almost no cancer care, Non-Hodgkin lymphoma (all types) and the tag lymphoma-evidence.