NCT04364178

Viral Specific T-Lymphocytes to Treat Adenovirus or CMV

Active, enrolled Phase 1, PHASE2 Last updated 6 May 2024

What this trial tests

Phase 1, PHASE2 trial testing Adenovirus Specific T- Lymphocytes in Adenovirus in 25 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

12 August 2020

Primary endpoint
1 April 2029

1 January 2032

Quick facts

Lead sponsor	Jessie L. Alexander
Phase	Phase 1, PHASE2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	12 August 2020
Primary completion	1 April 2029
Estimated completion	1 January 2032
Sites	2 locations across United States

Drugs / interventions tested

• Adenovirus Specific T- Lymphocytes
• Cytomegalovirus Specific T-Lymphocytes — full drug profile →

Conditions studied

• Adenovirus — all drugs for Adenovirus →
• Cytomegalovirus Infections — all drugs for Cytomegalovirus Infections →

Sponsor

Jessie L. Alexander — full company profile →

Who can join

Adults 1 Month to 65, any sex, with Adenovirus or Cytomegalovirus Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary purpose of this phase I/II study is to evaluate whether partially matched, ≥2/6 HLA-matched, viral specific T cells have efficacy against adenovirus and CMV in subjects who have previously received any type of allogeneic HCT or solid organ transplant (SOT), or have compromised immunity. Reconstitution of anti-viral immunity by donor-derived cytotoxic T lymphocytes has shown promise in preventing and treating infections with adenovirus and CMV. However, the weeks taken to prepare patient-specific products, and cost associated with products that may not be used limits their value. In this trial, we will evaluate viral specific T cells generated by gamma capture technology. Eligible patients will include HCT and/or SOT recipients, and/or patients with compromised immunity who have adenovirus or CMV infection or refractory viremia that is persistent despite standard therapy. Infusion of the cellular product will be assessed for safety and efficacy.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cell therapies in the clinic.
   Wang LL, Janes ME, Kumbhojkar N, Kapate N, et al · · 2021 · cited 99× · PMID 34027097 · DOI 10.1002/btm2.10214
2. CMV Infection and CMV-Specific Immune Reconstitution Following Haploidentical Stem Cell Transplantation: An Update.
   Luo XH, Zhu Y, Chen YT, Shui LP, et al · · 2021 · cited 21× · PMID 34777342 · DOI 10.3389/fimmu.2021.732826
3. Is It Feasible to Use CMV-Specific T-Cell Adoptive Transfer as Treatment Against Infection in SOT Recipients?
   García-Ríos E, Nuévalos M, Mancebo FJ, Pérez-Romero P. · · 2021 · cited 18× · PMID 33968058 · DOI 10.3389/fimmu.2021.657144
4. Adoptive Immunotherapy for Prophylaxis and Treatment of Cytomegalovirus Infection.
   Ouellette CP. · · 2022 · cited 17× · PMID 36366468 · DOI 10.3390/v14112370
5. Updates in Cytomegalovirus Prevention and Treatment in Solid Organ Transplantation.
   Doss KM, Heldman MR, Limaye AP. · · 2023 · cited 3× · PMID 37989636 · DOI 10.1016/j.idc.2023.10.001