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A Study of the LVIVO-TaVec122 Product in Subjects With Relapsed/Refractory B-cell Malignancies

4 juni 2026 uppdaterad av: Lei Fan, The First Affiliated Hospital with Nanjing Medical University

An Open-label Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the LVIVO-TaVec122 Product in Subjects With Relapsed/Refractory B-cell Malignancies

This is a single-arm, open-label and dose-escalation clinical study to evaluate the LVIVO-TaVec122 product in adult subjects with Relapsed/Refractory B-cell Malignancies.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

This is a single-arm, open-label clinical study to evaluate the safety, tolerability and efficacy of LVIVO-TaVec122 product in adult subjects with Relapsed/Refractory B-cell Malignancies. Subjects who meet the defined eligibility criteria will be enrolled with a core study period of approximately 2 years, including the screening, bridging therapy(if needed), treatment, and follow-up.

Studietyp

Interventionell

Inskrivning (Beräknad)

48

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Kina
    • Jiangsu
      • Nanjing, Jiangsu, Kina, 210029
        • The First Affiliated Hospital with Nanjing Medical University
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

  1. Subjects voluntary agreement to provide written informed consent.
  2. Age ≥ 18 years.
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  4. At least one evaluable tumor lesion.
  5. Relapsed and/or refractory Non-Hodgkin Lymphoma (NHL) , and relapsed and/or refractory Chronic Lymphocytic Leukemia (CLL) with treatment indications.
  6. Clinical laboratory values meet screening visit criteria.
  7. Adequate organ function.

Exclusion Criteria:

  1. Prior antitumor therapy with insufficient washout period.
  2. Prior treatment with allo-Hematopoietic stem cell transplantation (HSCT) or gene therapies.
  3. Patients who are positive for hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), and human immunodeficiency virus antibody (HIV-Ab).
  4. Known life-threatening allergic reaction, hypersensitivity reaction, or intolerance to study drug excipients and related excipients, including but not limited to Human Albumin, or those with a history of severe allergic reactions in the past (such as hypersensitivity reactions, or those with severe immune-related reactions such as the need for glucocorticoids to prevent anaphylaxis as assessed by the investigator).
  5. Female subjects who were pregnant, breastfeeding.
  6. Any condition deemed by the investigator as rendering the subject unsuitable for participation in this study.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: LVIVO-TaVec122 product
Each subject will be given a single-dose LVIVO-TaVec122 product infusion at each dose level.
Biologisk: LVIVO-TaVec122 product
Prior to infusion of the LVIVO-TaVec122 product, subjects will receive bridging therapy if needed.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
Tidsram: Through study completion, an average of 2 years after LVIVO-TaVec122 infusion (Day 1)
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Through study completion, an average of 2 years after LVIVO-TaVec122 infusion (Day 1)
Pharmacokinetics in peripheral blood
Tidsram: Through study completion, an average of 2 years after LVIVO-TaVec122 infusion (Day 1)
CAR positive T cells and CAR transgene percentage of in peripheral blood after LVIVO-TaVec122 infusion.
Through study completion, an average of 2 years after LVIVO-TaVec122 infusion (Day 1)
Pharmacokinetics in bone marrow
Tidsram: Through study completion, an average of 2 years after LVIVO-TaVec122 infusion (Day 1)
CAR positive T cells and CAR transgene percentage of in bone marrow after LVIVO-TaVec122 infusion.
Through study completion, an average of 2 years after LVIVO-TaVec122 infusion (Day 1)
The recommended Phase II dose (RP2D) for the treatment of this research
Tidsram: Through study completion, an average of 2 years after LVIVO-TaVec122 infusion (Day 1)
RP2D established through BF-BOIN design and the dose-limiting toxicity (DLT) occurring following LVIVO-TaVec122 infusion
Through study completion, an average of 2 years after LVIVO-TaVec122 infusion (Day 1)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overall Response Rate (ORR)
Tidsram: Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1)
Objective Response Rate (ORR) is defined as the proportion of subjects who achieve CR or PR after treatment via LVIVO-TaVec122 infusion
Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1)
Progression-free survival (PFS)
Tidsram: Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1)
Progression Free Survival (PFS) is defined as the time from the date of first infusion of the LVIVO-TaVec122 to the first documented disease progression or death, whichever occurs first
Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1)
Overall Survival (OS)
Tidsram: Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1)
Overall Survival (OS) is defined as the time from the date of first infusion of LVIVO-TaVec122 to death of the subject
Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1)
Time to Response (TTR)
Tidsram: Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1)
Time to Response (TTR) is defined as the time from the date of first infusion of LVIVO-TaVec122 to the date of the first response evaluation of the subject who has met all criteria for CR or PR
Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1)
Duration of Response (DoR)
Tidsram: Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1)
Duration of Remission (DoR) is defined as the time from the first documentation of remission (CR or PR) to the first documented relapse evidence of the responders
Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1)
Immunogenicity assessment of LVIVO-TaVec122 infusion
Tidsram: Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1)
The incidence of Anti-LVIVO-TaVec122 antibody in patients who received LVIVO-TaVec122 infusion
Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Samarbetspartners

Nanjing Legend Biotech Co.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

15 september 2026

Primärt slutförande (Beräknad)

30 oktober 2028

Avslutad studie (Beräknad)

30 september 2030

Studieregistreringsdatum

Först inskickad

1 juni 2026

Först inskickad som uppfyllde QC-kriterierna

4 juni 2026

Första postat (Faktisk)

5 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 juni 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • LB2601-0001

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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