Table 1.
Time of clinical assessments, intercurrent medical conditions, and adverse events during the observation period.
| Participant code (age in yearsa, sex, form of MS) | Time of year 2 assessment (monthsb) | Time of year 3 assessment (monthsb) | Intercurrent medical condition and adverse events related to a study procedure (associated treatment). |
|---|---|---|---|
| 1 (49, F, SPMS) |
24 | 36 | Urinary tract infection at 23 months (methenamine). Cataract of left eye at 36 months (laser-assisted cataract surgery). |
| 2 (54, F, SPMS) |
24 | Participant did not attend | Subacute deterioration in chronic suicidality due to change in social circumstances at 12 months (supportive treatment). |
| 3 (61, M, SPMS) |
24 | 35 | Atrial fibrillation at 8 months (rivaroxiban and metoprolol). Mechanical fall resulting in a right orbital floor fracture at 25 months (supportive treatment). Localized stage 0 melanoma and intra-epidermal carcinoma excised at 31 months. Diverticulosis and polyps of the sigmoid colon detected at 35 months (resection of polyps). |
| 4 (49, F, PPMS) |
24 | 36 | Hypothyroidism at 33 months (thyroxine). |
| 5 (60, F, SPMS) |
24 | 36 | Osteoporosis at 24 months (zoledronic acid). Back pain and bruising at LP site performed at year 2 and 3 (supportive treatment). |
| 6 (53, M, PPMS) |
23 | 35 | Back pain at LP site performed at year 2 (supportive treatment). |
| 8 (42, F, PPMS) |
Participant did not attendc | Participant did not attendc | Urinary tract infection and deep vein thrombosis of the lower limb at 17 months (rivaroxaban and antibiotics) |
| 9 (46, M, SPMS) |
24 | 40 | Bruise at site of blood collection performed at year 2 (supportive treatment). Intestinal pseudo-obstruction at 18 months (aperients and enemas) |
| 12 (60, M, PPMS) |
22 | 36 | NA |
| 13 (55, F, PPMS) |
22 | 36 | NA |
age at time of receiving EBV-specific T cell therapy.
months after completion of EBV-specific T cell therapy.
with the participant's consent, clinical information was obtained retrospectively from electronic medical records up to 36 months after T cell therapy.
PPMS, primary progressive multiple sclerosis; SPMS, secondary progressive multiple sclerosis; LP, lumbar puncture; NA, No intercurrent medical condition or adverse event related to study procedure was reported by the participant or observed. All references to time points refer to the time following the completion of EBV-specific T cell therapy. Participant 2 did not attend for the year 3 assessment. Participants 7, 10, and 11 did not receive T cell therapy in the Phase 1 clinical trial and were not included in this follow-up paper.