Clinical trials

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Condition / disease
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Status: Not yet recruiting

Evaluation of the Safety and Efficacy of LB-DTK-BKV in Patients With BK Virus-Associated Hemorrhagic Cystitis Following Allogeneic Hematopoietic Stem Cell Transplantation

The goal of this clinical trial is to assess efficacy of BK virus specific T cells (LB-DTK-BKV) to treat pediatric, adolescent, and adult patients with BK virus-associated hemorrhagic cystitis after allogenic hematopoietic stem cell transplantation (allo-HSCT). It will also evaluate the safety of LB-DTK-BKV using treatment-emergent adverse events (TEAEs). The main questions it aims to answer are: * Does LB-DTK-BKV reduce the number of BKV virus viral load in allo-HSCT patients with hemorrhagic cystitis? * Do adverse events occur after the second dose? Researchers will compare LB-DTK-BKV to a placebo to see if LB-DTK-BKV works to treat hemorrhagic cystitis in allo-HSCT patients. Participants will: * Receive a single intravenous infusion of LB-DTK-BKV at the baseline visit (low dose: 1x10\^7/m\^2; high dose: 2x10\^7/m\^2). * Receive the second dose of LB-DTK-BKV intravenously at the same dose 14 days after the first dose. * Visit the clinic every week for follow-up for 6 months after the first dose.

Participants needed: 42
Trial details
Phase: Phase 1, Phase 2Age: 12+Biological sex: AllType: InterventionalSponsor: LucasBioUpdated: Jul 24, 2026Locations: 9
Eligibility criteria

Patients who have undergone allogeneic hematopoietic stem cell transplantation,... [+17]

Individuals who have received treatment with ATG (Antithymocyte Globulin), Campa... [+28]

Status: Recruiting

Evaluation of Safety and Efficacy of Virus Specific T-Cell Administration in Pediatric Patients With Systemic Viral Infection Following Allogeneic Hematopoietic Stem Cell Transplantation.

The goal of this prospective clinical study is to evaluate the safety and efficacy of Multi-Virus Specific T cells (LB-DTK-MV) in pediatric patients with systemic viral infection, including CMV, EBV, and BKV, after 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? * What treatment emergent adverse events occur within 14 days after the second infusion? * Is there a clinically significant reduction in CMV, EBV, and BKV viral loads within 14 days following the second infusion? * Is there a clinically significant improvement in clinical symptoms within 14 days following 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 infusion.

Participants needed: 6
Trial details
Age: 1-25Biological sex: AllType: InterventionalSponsor: LucasBioUpdated: Jul 6, 2026Locations: 1
Eligibility criteria

Patients with CMV, EBV, and/or BKV infection that is resistant or refractory to... [+7]

Individuals who have received treatment with ATG (Antithymocyte Globulin), Campa... [+7]

Status: Recruiting

Evaluation of Safety and Efficacy of Autologous LB-DTK-CMV in Patients With Antiviral-Resistant and Refractory Cytomegalovirus Retinitis.

The goal of this exploratory clinical study is to evaluate the safety and efficacy of Cytomegalovirus-Specific T cells (LB-DTK-CMV) to treat patients diagnosed with antiviral-resistant and refractory cytomegalovirus retinitis. The main questions it aims to answer are: * What adverse events occur after the infusion of LB-DTK-CMV? * What is the duration of efficacy following treatment? * Is there a clinically significant reduction in CMV viral load in plasma and aqueous humor after the infusion? * Is there a clinically significant improvement in clinical symptoms after the infusion? Participants will: * Receive two infusions of LB-DTK-CMV at 2x10\^7cells/m\^2 at two-week intervals beginning at the baseline visit (Cycle 1). * Take a three-week resting period following completion of Cycle 1. * Receive two infusions of LB-DTK-CMV at 2x10\^7cells/m\^2 at two-week intervals beginning three weeks after the last dose of Cycle 1 (Cycle 2).

Participants needed: 5
Trial details
Age: 19+Biological sex: AllType: InterventionalSponsor: LucasBioUpdated: Jul 1, 2026Locations: 1
Eligibility criteria

Patients with persistent or progressive CMV retinitis despite systemic antiviral... [+7]

Individuals who have received treatment with ATG (Antithymocyte Globulin), Campa... [+23]

Status: Recruiting

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.

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.

Participants needed: 27
Trial details
Phase: Phase 1, Phase 2Age: 19+Biological sex: AllType: InterventionalSponsor: LucasBioUpdated: Jun 26, 2026Locations: 1
Eligibility criteria

CAR-T: Kymriah, Yescarta [+16]

Individuals who have received treatment with ATG (Antithymocyte Globulin), Campa... [+24]