An Early Phase 1 interventional study of Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes and Allogeneic Adenovirus-specific Cytotoxic T Lymphocytes in Allogeneic Hematopoietic Stem Cell Transplantation Recipient, Cytomegalovirus and Donor, sponsored by Sumithira Vasu. Recruiting at 2 sites in United States. Open to participants aged 1 Year to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Sumithira Vasu · Early Phase 1, Interventional, and Treatment
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Among 78 studies in Adenoviridae Infections with a site in United States — 17 open to participants now, 21 under way, 2 of them phase 3. Adenoviridae Infections · United States.
Among the 78 studies in Adenoviridae Infections with a site in United States, this one is the 44th largest by planned enrollment of the 68 interventional ones that give a count, is one of 2 that started in 2020, is one of 29 in phase 1, reaches primary completion later than 5 of the 18 other live ones, and was the 56th registered.
136 studies on the registry are indexed under Adenoviridae Infections; 34 are open to participants now.
Browse Adenoviridae Infections studies →17 of the 78 studies in Adenoviridae Infections with a site in United States are open now. Recruiting first, the newest first:
New York Medical College · Sites in United States
Ages 1 days–30 yrs
Dispatch Biotherapeutics · Sites in United States
Ages 18+
SymBio Pharmaceuticals · Sites in United States, Austria, Belgium and 10 more countries
Ages 2 mo+
Jessie L. Alexander · Sites in United States
Ages 1 mo–65 yrs
Monica Bhatia · Sites in United States
Ages 3 mo–26 yrs
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 25 Adenoviridae Infections studies recruiting now, 9 (36%) set no upper age limit and 12 (48%) stop at 75 or younger; 17 take children under 18; 4 take healthy volunteers.
This study: 1 Year to 85 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
78 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 43 · Phase 2 30 · Phase 3 9 · Phase 4 1
First in 2002; this study’s year is marked. 2 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 20 is below the median of 30 across 109 interventional studies indexed under Adenoviridae Infections.
Median enrollment 27 across the 68 interventional studies, 436 across the 8 observational. Of the 46 that completed or were terminated, 18 (39%) have results posted.
This tab as a report to print or save as PDF → With an account.
34 of 78 have an industry lead sponsor. The 10 most frequent:
Sumithira Vasu is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Sumithira Vasu has 1 study filed under Adenoviridae Infections — fewer than ten, so there is no comparison to draw.
6 of the studies in Adenoviridae Infections with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04673942EpicentRx, Inc.A Study of AdAPT-001 in Subjects With Sarcoma and Refractory Solid Tumors | 2026-12-01 |
| NCT03266627New York Medical CollegeAdenovirus-specific Cytotoxic T-lymphocytes for Refractory Adenovirus Infection | 2026-12-31 |
| NCT02048332Children's Hospital Medical Center, CincinnatiDonor-Derived Viral Specific T-cells (VSTs) | 2027-01 |
| NCT05271318TILT Biotherapeutics Ltd.Oncolytic Adenovirus Coding for TNFa and IL2 (TILT-123) With Pembrolizumab or Pembrolizumab (Phase 1a) and Pegylated Liposomal Doxorubicin (Phase 1b) as Treatment for Ovarian Cancer. | 2027-03 |
| NCT03665675Sumithira VasuDonor Virus-Specific CMV or AdV CTL to Treat CMV or AdV Reactivation or Disease After Solid Organ or HCT | 2027-03-20 |
Add all 6 to your calendar (.ics) → With an account.
Among the 78 studies in Adenoviridae Infections with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This trial studies the side effects and how well allogeneic cytomegalovirus-specific cytotoxic T lymphocytes (donor cytomegalovirus [CMV] specific cytotoxic T-lymphocytes [CTLs]) or allogeneic adenovirus-specific cytotoxic T lymphocytes (donor adenovirus-specific [AdV] specific CTLs) work in treating CMV or AdV reactivation or infection in participants who have undergone stem cell transplant or solid organ transplant. White blood cells from donors may be able to kill cancer cells in patients with cytomegalovirus or adenovirus that has come back after a stem cell or solid organ transplant.
PRIMARY OBJECTIVE I. Assess the safety and feasibility of administering virus specific-CTLs from haploidentical donors in transplant patients both solid organ transplantation (SOT) and hematopoietic cell transplantation (HCT) with CMV/AdV infection despite standard therapy.
OUTLINE:Patients are assigned to 1 of 2 Cohorts.
COHORT A: Patients receive allogeneic cytomegalovirus-specific cytotoxic T lymphocytes intravenously (IV). Patients undergo blood, urine, saliva, cerebrospinal fluid (CSF), and bronchoalveolar fluid sample collection on the trial.
COHORT B: Patients receive allogeneic adenovirus-specific cytotoxic T Lymphocytes IV. Patients undergo blood, urine, saliva, CSF, and bronchoalveolar fluid sample collection on the trial.
After completion of study treatment, participants are followed up at 1 year.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Cohort A (CMV): Must have documented CMV disease or reactivation, as by:
Unable to tolerate antiviral drugs due to renal toxicity, bone marrow suppression, transfusion dependent anemia and thrombocytopenia or neutropenia requiring growth factor support or other related organ injury
Unable to tolerate antiviral treatment due to renal toxicity, bone marrow suppression, transfusion dependent anemia and thrombocytopenia or neutropenia requiring growth factor support or other related organ injury
Exclusion Criteria:
Evidence of uncontrolled infection as follows:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive allogeneic cytomegalovirus-specific cytotoxic T lymphocytes IV. Participants with persistent infection are eligible for second infusion after 28 days.
Biological: Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes
Patients receive allogeneic adenovirus-specific cytotoxic T Lymphocytes IV. Participants with persistent infection are eligible for second infusion after 28 days.
Biological: Allogeneic Adenovirus-specific Cytotoxic T Lymphocytes
Given intravenously
Given intravenously
Incidence of adverse events defined by the National Cancer Institute Common Terminology Criteria for Adverse Events 4.0
Measured as the proportion of patients with acute (a) graft versus host disease (GvHD) grades III-IV or graft rejection/failure within 30 days of the last dose of cytotoxic T-lymphocytes (CTLs) or grades 3-5 infusion-related adverse events within 7 days of the last does of CTLs or grades 4-5 non-hematological adverse events within 30 days of the last dose of CTLs and that are not due to the pre-existing infection or the original malignancy or pre-existing co-morbidities. Will be calculated by dividing by all evaluable patients and the corresponding 95% confidence intervals will be calculated.
Time frame: Up to 30 days post infusion
Feasibility defined as identifying a suitable donor within 4 weeks and meeting minimum T cell doses in the final product
Time frame: Up to 1 year
Antiviral activity defined as response to viral load
Complete response, partial response, stable disease or progression will be defined and proportion of each outcome will be calculated.
Time frame: At day 28
Persistence of infused CTLs as measured by T cell gene rearrangement and effects on clinical signs of viral infection
Time frame: Up to 1 year
Overall survival
Kaplan-Meier survival function will be used to estimate the survival probability.
Time frame: From last CTL infusion till death, assessed at 6 and 12 months
Risk for chronic GVHD
Survival analysis method will be applied. Time to chronic GVHD will be defined from time of the last CTL infusion to the onset of chronic GVHD, or the last clinical assessment date if no chronic GVHD. Cumulative incidence of chronic GVHD at 6 and 12 months will be estimated.
Time frame: At 6 and 12 months post CTL infusion
Systemic infections
Will be reported by etiologic agent, site of disease, date of onset, and severity.
Time frame: Within 6 months of CTL infusion
Secondary graft failure
Proportion of secondary graft failure for both populations will be assessed at 30 days post CTL infusion will be calculated and 95% confidence intervals will be estimated accordingly.
Time frame: 30 days post-CTL infusion
Effects of cytomegalovirus (CMV) specific-CTL on viral loads assessed by weekly reverse transcriptase-polymerase chain reaction
Time frame: Up to 1 year
Viral reactivations
Proportion of viral reactivations within 6 months will be calculated and 95% confidence intervals will be estimated accordingly.
Time frame: Up to 6 months
Clinical response to CTL infusions
Time frame: At 6 weeks and 3 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0".
Time frame: Up to 1 year
Not enrolling at this site.
Plan to share: No
Started Nov 2020 (actual). Primary completion is estimated for Mar 2027, 76 months after the start.
Of 23 phase 1 interventional studies under Adenoviridae Infections, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 42 and three quarters within 101. This study's planned 76 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes
Sumithira Vasu