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. Author manuscript; available in PMC: 2022 Aug 1.
Published in final edited form as: Lancet Neurol. 2021 Aug;20(8):639–652. doi: 10.1016/S1474-4422(21)00174-5

Table 1.

Patient and donor summary table.

Patient
Age/Sex
Underlying disease
Immune suppressive treatment history
Absolute values
CD4/CD8/CD19 at baseline
Donor
Age/Sex
Degree of HLA-match
DonorJCV Ab status
Clinical Course
(Time 0=first PyVST infusion)
Standardized Clinical Scale Scores
(baseline → final visit)
• mRS
• KPS
• MMSE
JCV CSF copies per ml
(baseline → last value)
Time from first PyVST infusion to last value
1
62/F
ICL/CVID/cyclic neutropenia
Remote treatment with prednisone, methotrexate, TNF-inhibitor
21/416/283 Donor 1:
39/F
6/10 match
JCV Ab status unknown
Neurological symptom onset: Month -6
Diagnosis of PML: Month -4
Died of complications of PML: Month 6
PML onset with rapid development of diplopia,severe truncal and appendicular ataxia, requiring bilateral assistive device for ambulation. Received 2 infusions of pembrolizumab, however symptoms continued to progress with worsening ataxia, cerebellar dysarthria, impaired eye movements, intractable hiccups; wheelchair-bound. Received two PyVST infusions from Donor 1 and one from Donor 2, with continued progression of symptoms. Withdrew from study and entered hospice care two months following last PyVST infusion.
mRS
4→4
KPS
40→40
MMSE
26→28
27,429→77,774
Month 3
Donor 2:
64/F
2/10 match
JC Ab negative
2
61/F
Microscopic polyangiitis
Remote chronic prednisone Rituximab, last 2 months prior to PyVST
706/101/0 40/F
5/10 match
JCV Ab positive
Neurological symptom onset: Month -1
Diagnosis of PML: Month -1
Survived PML: last communication > 36 months
PML onset with progressive decline in memory and language over weeks, which developed into severe expressive aphasia, apraxia and mild right-sided weakness. Following first PyVST infusion, clinically stabilized. By Month 6 had improved use of right hand, further improved by Month 12.
mRS
3→3
KPS
70→70
MMSE
22→28
609→Undetected
Month 9
3
53/F
CLL
Remote rituximab, CFR, bendamustine, ibrutinib/obinutuzumab, CART, 2 months prior to PyVST
45/19/0 58/F
10/10 match
JCV Ab status unknown
Neurological symptom onset: Month -2
Diagnosis of PML: Month -1
Died of complications of PML: Month 4
PML onset with progressive ataxia, abnormal eye movements with nystagmus, dysarthria with continued neurological deterioration following 2 PyVST infusions. By Day 14 post infusion 2, patient had developed severe bulbar dysfunction requiring NG tube and total care for ADL.
Withdrew from study to enter hospice care within 1 month following second PyVST infusion.
mRS
4→5
KPS
40→30
MMSE
28→4
62,963→109,880
Month 2
4
71/M
Lymphoma (DLBC)
Remote chemo (R-CHOP and intrathecal methotrexate; R-DICE x 3; R-BEAM)
Autologous BMT
217/426/53 44/M
5/10 match
JCV Ab status unknown
Neurological symptom onset: Month -2
Diagnosis of PML: Month -2
Presumed dead of complications of Stage IV lung cancer: > Month 12, date unknown
PML onset with change in mental status, geographic disorientation with inability to find his way in his own home. Subsequently developed dense right sided weakness with inability to ambulate independently. Following first PyVST infusion, stabilized clinically. In the subsequent months, right hemiparesis improved such that by Month 6 follow-up was able to ambulate using a walker and had regained limited ability to use his right hand. At last communication, one year following completion of PyVST treatment, patient reported new diagnosis of Stage IV lung cancer and decision to enter hospice care.
mRS
4→4
KPS
40→50
MMSE
14→18
333→18
Month 3
5
40/F
SLE
Remote azathioprine, prednisone, methotrexate, belimumab Rituximab, last 4 months prior to PyVST
177/112/1 Donor 1:
39/M
5/10 match
JCV Ab positive
Neurological symptom onset: Month -2
Diagnosis of PML: Month -2
Died of complications of SLE: Month 14
PML onset with ataxia, slurred speech, right sided weakness and apraxia with rapid progression to being bed-bound, aphasic with cortical visual impairment. By three weeks after first PyVST infusion, clinical stabilization with subsequent improved cognition, vision and motor function following 2nd and 3rd infusions. By Month 6 following completion of PyVST treatment, able to ambulate using a walker, speech improved with recovery of limited reading and writing and use of tools. By Year 1, had experienced exacerbation of underlying SLE, leading to severe debilitation and inability to travel, and withdrew from study.
mRS
4→4
KPS
50→50
MMSE
13→21
9564→1354
Month 7
Donor 2:
35/M
5/10 match
JCV Ab positive
6
40/F
Follicular Lymphoma
Bendamustine, Rituximab, last 6 months prior to PyVST
230/134/0 64/F
6/10 match
JCV Ab negative
Neurological symptom onset: Month -6
Diagnosis of PML: Month -5
Died of complications of PML: Month 4
PML onset with progressive cortical visual impairment with quadrantopsia/alexia/simultag-nosia, developing into cortical blindness. Received a total of 3 PyVST infusions with no benefit and neurological symptoms progressed with left hemiparesis, bulbar symptoms and cognitive changes. One month following last PyVST infusion, withdrew from study and entered hospice care.
mRS
3→4
KPS
60→40
MMSE
19→7
38,772→2,830,385
Month 2.5
7
60/M
HBV/HDV
Pegylated α interferon
87/135/67 19/F
5/10 match
JCV Ab positive
Neurological symptom onset: Month -4
Diagnosis of PML: Month -3
Survived PML: last communication >24 months
PML onset with right hand weakness and ataxia; symptoms progressed to dense right sided weakness, diplopia and dysarthria. Following first PyVST infusion, experienced initial worsening of symptoms with loss of ability to ambulate independently; following the 2nd and 3rd infusions, clinical stabilization and some improvement in speech and right sided weakness. By Month 6 after completion of PyVST treatment, experienced slight worsening of neurological symptoms, in context of progressive liver failure and ascites with no evidence of PML reactivation.
Unable to return for Year 1 visit due to general medical debilitation.
mRS
4→4
KPS
60→60
MMSE
25→28
782→Undetected
Month 8
8
71/M
CLL
Remote ofatumumab, alemtuzumab, prednisone
Rituximab, last 6 months prior to PyVST
69/58/2 43/F
2/10 match
JCV Ab positive
Neurological symptom onset: Month -3
Diagnosis of PML: Month -2
Survived PML: last communication >16 months
PML onset with progressive worsening dysarthric speech, left upper extremity weakness; dysphagia, requiring PEG. Received one PyVST infusion and withdrew from study 2 weeks later due to burden of trial participation.
mRS
3→3
KPS
40→40
MMSE
28→29
362→533
Week 2
9
40/F
SCID with spontaneous reversion mutation; hemolytic anemia
Corticosteroids, rituximab, last 3 months prior to
150/104/2 45/M
5/10 match
JCV Ab positive
Neurological symptom onset: Month -4
Diagnosis of PML: Month -3
Died of complications of PML: Month 2
PML onset with cognitive changes, apathy,slurred speech; progressive left hemiparesis and left hemianopsia; loss of ability to ambulate, decreased attentiveness, minimal to no verbalization. Received one PyVST infusion with no benefit; over subsequent weeks became increasingly less interactive with inability to take nutrition by mouth. By 2 months following PyVST infusion, withdrew from study and entered hospice care.
mRS
4→4
KPS
40→40
MMSE
9→0
51,230→20,927
Month 1
10
35/F
CVID
untreated
310/112/7 33/F
5/10 match
JCV Ab negative
Neurological symptom onset: Month -2
Diagnosis of PML: Month -1
Died of complications of PML: Month 2
PML onset with right UE weakness and expressive aphasia; progression to right hemiparesis and hemisensory loss. Received 2 infusions of PyVST with no benefit; neurological symptoms progressed to right hemiplegia, global aphasia and decreased attentiveness. By 2 weeks following 2nd PyVST infusion, withdrew from study and entered hospice care.
mRS
4→4
KPS
50→40
MMSE
8→0
344,163→14,654
Month 2
11
57/M
CLL
untreated
683/1,045/11,562 54/F
10/10 match
JCV Ab negative
Neurological symptom onset: Month -5
Diagnosis of PML: -3
Survived PML: last communication >24 months
PML onset with left inferior quadrantopsia and subsequent development of cortical visual impairment; decreased dexterity left hand; partial complex seizures. Following first PyVST infusion, experienced progressive improvement in vision such that following second infusion regained limited ability to read. Progressive improvement in vision over following months.
mRS
3→2
KPS
70→70
MMSE
28→29
74→32
Month 3
12
72/M
CLL
Remote obinutuzumab
367/132/24 30/M
7/10 match
JCV Ab positive
Neurological symptom onset: Month -2
Diagnosis of PML: -1
Survived PML: last communication > 13 months
PML onset with left sided ataxia, bulbar symptoms with dysarthria and dysphagia, ataxic gait. Continued slow worsening following first two PyVST infusions; by the third infusion, demonstrating improved strength and dysphagia. Withdrew from study following completion of PyVST treatment due difficulty with travel. At last communication, was neurologically stable13 months post PyVST treatment completion.
mRS
2→3
KPS
70→50
MMSE
27→27
1,648→1,476
Month 2.5

Abbreviations: PyVST, polyomavirus specific T cells; M, male; F, female; Ab, antibody; MRS, Modified Rankin Scale (0 no signs or symptoms → 5 dead); KPS, Karnofsky Performance Scale (100 no signs or symptoms → 0 dead); MMSE, mini-mental status exam (30 best score → 0 worst score); CSF, cerebrospinal fluid; CLL, chronic lymphocytic leukemia; ICL, idiopathic lymphopenia; CVID, combined variable immunodeficiency; CAR, chimeric antigen receptor; NG, naso gastric; ADL, activities of daily living; DLBC, diffuse large B cell; RCHOP, rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, prednisolone; R-DICE, rituximab, ifosfamide, carboplatin, etoposide phosphate; R-BEAM, rituximab, carmustine, etoposide, cytarabine, melphalan; BMT, bone marrow transplant; SLE, systemic lupus erythematosus; HBV, hepatitis B; HDV, hepatitis; PEG, percutaneous endoscopic gastrostomy.