Evaluation of the Safety and Efficacy of LB-DTK-MV in Patients Diagnosed With Antiviral-Resistant CMV, BKV, or EBV Infection or Associated Diseases Following Anticancer Therapy or Allogeneic Hematopoietic Stem Cell Transplantation.

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorLucasBio

About this trial

The goal of this clinical trial is to evaluate the efficacy and safety of Multi-Virus Specific T cells (LB-DTK-MV) to treat patients diagnosed with antiviral-resistant CMV, BKV, or EBV infection or associated diseases after anticancer therapy or allogeneic hematopoietic stem cell transplantation (allo-HSCT). The main questions it aims to answer are:

* What is the maximum tolerated dose of LB-DTK-MV based on dose-limiting toxicity? * Does the number of CMV, BKV, or EBV virus viral load decrease within 7 or 14 days after the second infusion of LB-DTK-MV? * Do treatment emergent adverse events occur after the second infusion?

Participants will:

* Receive a single intravenous infusion of LB-DTK-MV during the baseline visit (low dose: 1x10\^7/m\^2; high dose: 2x10\^7/m\^2). * Receive the second infusion of LB-DTK-MV intravenously at the same dose 14 days after the first infusion. * Attend weekly follow-up visits at the clinic for 6 months after the first dose.

Eligibility criteria

Qualifiers

CAR-T: Kymriah, Yescarta

Bispecific Antibody: Glofitamab, Mosunetuzumab, Teclistamab, Elranatamab, etc

Patients diagnosed with single or multiple, antiviral-resistant CMV, BKV, and/or EBV despite receiving standard treatment.

Patients who are able to reduce their steroid dosage to 0.5mg/kg/day of Prednisolone (or an equivalent dose) or less.

Disqualifiers

Individuals who have received treatment with ATG (Antithymocyte Globulin), Campath (Alemtuzumab), or other T-cell immunosuppressive monoclonal antibodies within 28 days prior to the first dose.

Uncontrolled hypertension

Systolic BP ≥ 160 mmHg or diastolic BP ≥ 100 mmHg despite taking antihypertensive medication.

Severe hyperglycemia with HbA1C ≥ 10.0%

Trial design

Treatments tested in this trial

  • LB-DTK-MV

Treatment groups

27 Participants
are divided into 1 treatment group

Sponsors and collaborators