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CAR T-cell therapy is given at specialist centres, and a team there decides. For large B-cell lymphoma that does not respond to first treatment or returns within a year, CAR T cells are now the standard next step, so early referral matters. The centre checks your fitness, heart, brain and blood, and you will need to stay near the hospital, with someone to help, for at least two weeks after.
EBMT 2025 indications (Table 1, adults; category/evidence level as printed): in large B-cell lymphoma, CAR T cells are standard of care (S/I) for primary refractory disease, early relapse with untested or chemoresistant disease and early chemosensitive relapse, where axicabtagene ciloleucel or lisocabtagene maraleucel beat salvage chemotherapy and autologous transplant in two phase III trials; for late relapse autologous transplant remains standard (S/II) and CAR T a clinical option (CO/II); after a failed autograft CAR T is standard (S/II). Follicular lymphoma: CAR T within the EMA labels, standard for refractory relapse (S/II). Mantle cell lymphoma: not first line outside trials; a clinical option second line after primary BTK inhibitor failure. Myeloma: idecabtagene vicleucel and ciltacabtagene autoleucel within their labels. Primary CNS lymphoma relapse: clinical option. Hodgkin lymphoma: not convincingly better than other options to date.
EBMT/JACIE 2019: the decision is made by a multidisciplinary team in a designated centre; cumulative chemotherapy harms T-cell quality, so plan collection early. SITC 2020: prior allogeneic transplant, BiTE or antibody therapy is no bar if the target antigen is expressed (LE: 4); weigh ECOG performance status; recent or active intracranial haemorrhage excludes (LE: 4); refer for neurological review if there is inflammatory neurological disease or CNS involvement; baseline CRP, ferritin, LDH, blood count, chemistry and echocardiogram or MUGA (LE: 4). FDA 2025: the REMS ended; labels now ask patients to stay near a healthcare facility for at least two weeks and not to drive for two weeks.
Why: The treatment and its side effects need a specialist team and hospital set up for them.
“The decision to treat a patient with CAR T cells therapy should be made collectively at a multidisciplinary team meeting in a designated center for CAR T-cell therapy.”
Why: In two phase III trials CAR T cells kept the lymphoma controlled for longer than chemotherapy and transplant in this group.
“For patients with primary refractory disease or early relapse with untested or chemorefractory disease, treatment with axi-cel or liso-cel represents the current standard of care.”
European Society for Blood and Marrow Transplantation, Bone Marrow Transplantation 2025 · S/I
Why: Autologous transplant still works well for late relapse and has not been beaten in a trial.
“Patients with late relapses face reasonable outcomes with auto-HCT and this standard has not been challenged by a clinical trial as of today.”
European Society for Blood and Marrow Transplantation, Bone Marrow Transplantation 2025 · S/II
Why: The licence and the evidence are for disease that has failed earlier treatment.
“With Bruton’s TKIs moving to 1st-line treatment, CAR-T has become a clinical option as 2nd-line therapy in patients with primary Bruton’s TKIs failure.”
European Society for Blood and Marrow Transplantation, Bone Marrow Transplantation 2025
Why: Each course of chemotherapy weakens the T cells from which the product is made.
“There is evidence that cumulative chemotherapy exposure adversely affects the quality of circulating T cells.”
Why: These do not stop CAR T cells working if the target is still present.
“Patients who have previously undergone allo-HSCT, bispecific T cell engager (BiTE) therapy, anti-CD19 monoclonal antibody (mAb) therapy, and mAbs against other targets (eg, rituximab) may be treated with CAR T cells, provided the patient’s disease still expresses the target antigen”
Why: Side effects can be severe; a recent brain bleed makes neurotoxicity especially dangerous.
“Patients with evidence of recent or active intracranial hemorrhage should not undergo CAR T cell therapy”
Why: Existing brain disease changes the risk and the monitoring plan for neurotoxicity.
“Patients with history of inflammatory neurological conditions or current CNS disease involvement should be referred for additional neurological consultation prior to initiating CAR T cell therapy.”
Why: Baselines make it possible to recognise toxicity early, and heart function must be adequate.
“Prior to CAR T cell therapy, treating physicians should order CRP, ferritin, lactate dehydrogenase (LDH), complete blood counts, comprehensive metabolic panel (including Mg/Pho), and transthoracic echocardiogram (TTE) or multigated acquisition (MUGA) scan.”
Why: Cytokine release syndrome and neurotoxicity usually start in the first two weeks and can come on fast.
“Specifically, labeling update included revision to language to monitor patients for at least two weeks including daily monitoring for at least one week; to instruct patients to remain within proximity of a healthcare facility for at least two weeks; and to advise patients to avoid driving for two weeks following product administration”
How care is usually carried out, read from the guidelines and standards cited. Your own team's protocol and their judgement come first; this page is for understanding it, not for doing it yourself.
For who should be referred, the EBMT 2025 indications are the most recent guideline read in full: CAR T cells are standard of care (S/I) for large B-cell lymphoma that is primary refractory or relapses early, on the strength of two randomised phase III trials, and the standard after a failed autograft (S/II); autologous transplant stays standard for late relapse (S/II). For the eligibility work-up, SITC 2020 (LE: 4) and EBMT/JACIE 2019 (ungraded) agree on a specialist multidisciplinary decision, performance status, baseline inflammatory markers and cardiac function, and neurological assessment. EBMT 2025 and its retrospective evidence leave one open point: for early chemosensitive relapse that reaches complete remission on salvage, EBMT rates CAR T S/I but also calls autologous transplant a valid clinical option (CO/II). In the US the FDA ended the REMS in June 2025 and relaxed proximity and driving restrictions to two weeks; European labels were not read.
European Society for Blood and Marrow Transplantation, Bone Marrow Transplantation 2025 · SITC, Journal for ImmunoTherapy of Cancer 2020 · EBMT and JACIE, Haematologica 2020 · US Food and Drug Administration 2025 · EBMT, JACIE and EHA, Annals of Oncology 2022
Where it differs: For large B-cell lymphoma relapsing early but reaching complete remission on salvage, consolidates with high-dose therapy and autologous transplant rather than CAR T cells.
Evidence: Rated CO/II; a retrospective analysis found better progression-free survival with autologous transplant than CAR T in this group, but included no second-line CAR T and mostly tisagenlecleucel.
European Society for Blood and Marrow Transplantation, Bone Marrow Transplantation 2025
Where it differs: Removes the requirement for specially certified hospitals with immediate on-site tocilizumab; labels require monitoring for at least two weeks with daily monitoring for at least one, proximity for two weeks and no driving for two weeks.
Evidence: Regulatory decision based on established management guidelines and stable adverse event reporting.
| Recommendation | Grade, as printed | Source |
|---|---|---|
| CAR T for primary refractory or early relapsed large B-cell lymphoma | S/I (standard of care; EBMT evidence level I) | European Society for Blood and Marrow Transplantation, Bone Marrow Transplantation 2025 |
| Autologous transplant for late relapse of large B-cell lymphoma | S/II; CAR T CO/II | European Society for Blood and Marrow Transplantation, Bone Marrow Transplantation 2025 |
| Prior allogeneic transplant, BiTE or antibody therapy is no bar if the antigen is expressed | LE: 4 | SITC, Journal for ImmunoTherapy of Cancer 2020 |
| No CAR T with recent or active intracranial haemorrhage | LE: 4 | SITC, Journal for ImmunoTherapy of Cancer 2020 |
| Baseline CRP, ferritin, LDH, blood count, chemistry and echocardiogram or MUGA | LE: 4 | SITC, Journal for ImmunoTherapy of Cancer 2020 |
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