Table 5.

Recommendations on washout period before CT, leukapheresis, LD specifically for ADs.

Type of therapy	Specific recommendations in ADsa	Comments
Steroids	May be administered at dosages ≤10 mg/day prednisone (or equivalent), by 7 days before leukapheresis and before LD; after leukapheresis and before LD, steroids may be administered at higher doses as needed for bridging therapy.	Depending on the patient's clinical picture; topic/inhaled steroids permitted.
Hydroxychloroquine	No specific need for a washout period	Individualized decision
Mycophenolate Mofetil, Azathioprine, Calcineurin inhibitors, mTOR inhibitors JAK inhibitors	Discontinued at least 2 weeks before leukapheresis	Tapering can be considered based on individual disease
Dimethyl fumarate, Fingolimod	Discontinued at least 6 weeks before leukapheresis
Bortezomib/Proteasome inhibitorsb	Discontinued at least 3 weeks before leukapheresis
Cladribine	Discontinued at least 6 months before leukapheresis	Try to avoid if T cell therapy is planned
Cyclophosphamide Methotrexate	Discontinued at least 3 weeks before leukapheresis	The washout period is recommended to ensure T-cell activity at time of collection and to reduce potential toxicity for patients
Belimumab, B cell targeting antibodies (e.g. anti CD20)	Discontinued at least 1 week before leukapheresis	Irrelevant for T cell apheresis and CART production;
Anti-cytokine antibodies Natalizumab (humanized anti α4-integrin)	Discontinued at least 1 month before leukapheresis discontinued at least 6 weeks before leukapheresis	The washout period is recommended to reduce toxicity (ie. infections, such as PML) for patients and impact on B-cell, while preserving disease control, especially for CART
Alemtuzumab (anti CD52 mAb) Daratumumab (anti-CD38 mAb)b ATGb	Discontinued at least 6 weeks before leukapheresis	Try to avoid anti T cell directed antibody therapy (CD52, ATG, CD38) if B cell targeted CART is considered as next treatment

Abbreviations: ADs autoimmune diseases; ATG anti-thymocyte globulin; CART chimeric antigen receptors T cells; CT cellular therapy; JAK Janus kinase; LD lymphodepleting conditioning; mAb monoclonal antibody; mTOR mammalian target of rapamycin; PML progressive multifocal leukoencephalopathy.

^aSuggested wash out period vary according to AD type and activity, manufacturing recommendations, individual decisions and trials, mostly no data available. Suggestions are based on pharmaceutical wash out periods, sometimes lasting effects on T cells, associated risks of infections (such as viral reactivation), available recommendations^9,80 and loss of disease control.

^bNone approved drugs frequently used in off-label.