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A Modular, Phase I/II Study to Evaluate CT204V-CD19 x CD20 in Participants With Relapsed or Refractory B-Cell Malignancies. (CT204V)

6. listopadu 2026 aktualizováno: AstraZeneca

A Modular, Phase I/II, Open-label, Single-arm, Multicenter, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of CT204V-CD19 × CD20, an In Vivo Lentiviral Vector Gene Therapy Generating Dual Targeting Anti-CD19/CD20 Chimeric Antigen Receptor (CAR)-T Cells in Participants With Relapsed or Refractory B-Cell Malignancies

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of CT204V-CD19 × CD20, a dual targeting in vivo gene therapy generating anti-CD19/CD20 CAR-T cells in participants with R/R B-cell malignancies.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

160

Fáze

  • Fáze 2
  • Fáze 1

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • * Participants must be at least 18 years of age.
  • * Confirmed expression of CD19 and/or CD20.
  • * Histologically confirmed and measurable disease for all disease subtypes.
  • * ECOG performance status 0 or 1.
  • * Adequate organ and bone marrow function.
  • * Body weight of at least 45 kg.
  • * Contraceptive/barrier requirement consistent with local regulations.
  • * Capable of giving signed informed consent.

Exclusion Criteria:

  • * History of malignancy unless disease-free for ≥ 3 years, with exceptions.
  • * Active CNS involvement by malignancy.
  • * History of cardiac lymphoma involvement.
  • * Richter's transformation of CLL.
  • * Ongoing or impending oncologic emergency.
  • * Active uncontrolled bacterial, viral, or fungal infection.
  • * Active hepatitis B or C.
  • * Positive HIV test.
  • * Positive HTLV-1/2 antibody test.
  • * Ongoing non-hematologic toxicities from prior therapy.
  • * History of any grade IEC-HS, Grade ≥ 3 CRS, or Grade ≥ 2 NT during prior CAR-T cell therapy.
  • * History of allogeneic stem cell or solid organ transplantation.
  • * Primary immunodeficiency disorder.
  • * History of specific autoimmune diseases.
  • * Significant neurological or psychiatric conditions.
  • * Receipt of prior treatment containing VSV-G.
  • * Receipt of certain therapies within specified washout periods.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: CT204V-CD19 × CD20

Participants will receive CT204V-CD19 × CD20, an In Vivo Lentiviral Vector Gene Therapy, generating dual targeting anti-CD19/CD20 Chimeric Antigen Receptor (CAR)-T cells.

Experimental

Ostatní jména:
  • CT204V

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Adverse Events(AEs)/Serious Adverse Events (SAEs), Phase 1 of the study.
Časové okno: Up to 15 years

Incidence and severity of Adverse Events(AEs)/Serious Adverse Events (SAEs), Phase 1 of the study.

Up to 15 years
Number of Dose-Limiting Toxicities (DLTs) events during dose escalation, Phase 1 of the study.
Časové okno: Up to 28 days.

Incidence of Dose-Limiting Toxicities (DLTs) during dose escalation, Phase 1 of the study.

Up to 28 days.
Number of AEs leading to dose reduction, withdrawal, interruption, Phase 1 of the study.
Časové okno: Up to 1 year.

Incidence of AEs leading to dose reduction, withdrawal, interruption, Phase 1 of the study.

Up to 1 year.
Number of AEs leading to death, Phase 1 of the study.
Časové okno: Up to 15 years

Incidence of AEs leading to death, Phase 1 of the study.

Up to 15 years
Number of AESI (adverse events of special interest), Phase 1 of the study.
Časové okno: Up to 15 years

Incidence of AESI (adverse events of special interest), Phase 1 of the study.

Up to 15 years
Objective Response Rate (Complete Response+Partial Response) per Lugano Classification, Phase 2 of the study.
Časové okno: Up to 24 months.

To assess the efficacy based on ORR (CR+PR) events.

Up to 24 months.
Complete Response (CR) rate, Phase 2 of the study.
Časové okno: Up to 24 months.

To assess the efficacy based on CR rate.

Up to 24 months.
Best Overall Response (BOR), Phase 2 of the study.
Časové okno: Up to 24 months.

To assess the efficacy based on BOR rate.

Up to 24 months.
Duration of Response (DoR), Phase 2 of the study.
Časové okno: Up to 24 months.

To assess the efficacy based on DoR rate.

Up to 24 months.
Duration of Complete Response (DoCR), Phase 2 of the study.
Časové okno: Up to 24 months.

To assess the efficacy based on DoCR rate.

Up to 24 months.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Objective Response Rate (Complete Response+Partial Response) per Lugano Classification, Phase 1 of the study.
Časové okno: Up to 24 months post-infusion.

To evaluate the preliminary antitumor activity of CT204V. ORR (CR+PR) per Lugano Classification based on ORR, as assessed by the investigator.

Up to 24 months post-infusion.
Viral vector PK parameter AUClast, Phase 1 of the study.
Časové okno: Up to 24 months post-infusion.

Quantification of CT204V viral vector genomes (viral titer) in peripheral blood per PK parameter AUClast, as assessed by the investigator.

Up to 24 months post-infusion.
Cellular Kinetics (CK) of CT204V CAR transgene parameter AUC0-28/AUClast, Phase 1 of the study.
Časové okno: Up to 24 months post-infusion.

Quantification of CT204V CAR transgene levels in peripheral blood per CAR transgene PK parameter AUC0-28/AUClast, as assessed by the investigator.

Up to 24 months post-infusion.
Incidence of Anti-Drug Antibodies (ADA), Phase 1 of the study.
Časové okno: Up to 24 months post-infusion.

To evaluate the humoral immunogenicity of CT204V and its vector components based on incidence of humoral immunogenicity (ADA) against CT204V and/or vector components, as assessed by the investigator.

Up to 24 months post-infusion.
Frequency and severity of AEs/SAEs
Časové okno: Up to 15 years

To further characterize the safety of CT204V with selected prophylaxis regimen.

Up to 15 years
Complete Response (CR) rate, Phase 1 of the study.
Časové okno: Up to 24 months post-infusion.

To evaluate the preliminary antitumor activity of CT204V per CR rate, as assessed by the investigator.

Up to 24 months post-infusion.
Best Overall Response (BOR), Phase 1 of the study.
Časové okno: Up to 24 months post-infusion.

To evaluate the preliminary antitumor activity of CT204V based on BOR, as assessed by the investigator.

Up to 24 months post-infusion.
Duration of Response (DoR), Phase 1 of the study.
Časové okno: Up to 24 months post-infusion.

To evaluate the preliminary antitumor activity of CT204V based on DoR. as assessed by the investigator.

Up to 24 months post-infusion.
Duration of Complete Response (DoCR), Phase 1 of the study.
Časové okno: Up to 24 months post-infusion.

To evaluate the preliminary antitumor activity ofCT204V based on DoCR, as assessed by the investigator.

Up to 24 months post-infusion.
Viral vector PK parameter Cmax/Clast, Phase 1 of the study.
Časové okno: Up to 24 months post-infusion.

Quantification of CT204V viral vector genomes (viral titer) in peripheral blood per PK parameter Cmax/Clast, as assessed by the investigator.

Up to 24 months post-infusion.
Viral vector PK parameter Tmax/Tlast, Phase 1 of the study.
Časové okno: Up to 24 months post-infusion.

Quantification of CT204V viral vector genomes (viral titer) in peripheral blood per PK parameter Tmax/Tlast, as assessed by the investigator.

Up to 24 months post-infusion.
Cellular Kinetics (CK) of CT204V CAR transgene parameter Cmax/Clast, Phase 1 of the study.
Časové okno: Up to 24 months post-infusion.

Quantification of CT204V CAR transgene levels in peripheral blood per CAR transgene PK parameter Cmax/Clast, as assessed by the investigator.

Up to 24 months post-infusion.
Cellular Kinetics (CK) of CT204V CAR transgene parameter Tmax/Tlast, Phase 1 of the study.
Časové okno: Up to 24 months post-infusion.

Quantification of CT204V CAR transgene levels in peripheral blood per CAR transgene PK parameter Tmax/Tlast.

Up to 24 months post-infusion.
Quantification of CT204V viral vector genomes (viral titer) in peripheral blood, Phase 2 of the study.
Časové okno: Up to 24 months post-infusion.

Quantification of CT204V viral vector genomes (viral titer) in peripheral blood, central read, central read.

Up to 24 months post-infusion.
Quantification of CT204V CAR transgene levels (copies/μg gDNA) in peripheral blood, Phase 1 of the study.
Časové okno: Up to 24 months post-infusion.

Quantification of CT204V CAR transgene levels (copies/μg gDNA) in peripheral blood, as assessed by the investigator.

Up to 24 months post-infusion.
Cellular Kinetics (CK) of CT204V CAR transgene parameter AUC0-28/AUClast, Phase 2 of the study.
Časové okno: Up to 24 months post-infusion.

Quantification of CT204V CAR transgene levels in peripheral blood per CAR transgene PK parameter AUC0-28/AUClast, central read.

Up to 24 months post-infusion.
Incidence of Anti-Drug Antibodies (ADA), Phase 2 of the study.
Časové okno: Up to 24 months post-infusion.

To evaluate the humoral immunogenicity of CT204V and its vector components based on incidence of humoral immunogenicity (ADA) against CT204V and/or vector components, central read.

Up to 24 months post-infusion.
Complete Response (CR) rate, Phase 2 of the study.
Časové okno: Up to 24 months post-infusion.

To evaluate the preliminary antitumor activity of CT204V per CR rate, central read.

Up to 24 months post-infusion.
Best Overall Response (BOR), Phase 2 of the study.
Časové okno: Up to 24 months post-infusion.

To evaluate the preliminary antitumor activity of CT204V based on BOR, central read.

Up to 24 months post-infusion.
Duration of Response (DoR), Phase 2 of the study.
Časové okno: Up to 24 months post-infusion.

To evaluate the preliminary antitumor activity of CT204V based on DoR, central read.

Up to 24 months post-infusion.
Duration of Complete Response (DoCR), Phase 2 of the study.
Časové okno: Up to 24 months post-infusion.

To evaluate the preliminary antitumor activity ofCT204V based on DoCR, central read.

Up to 24 months post-infusion.
Viral vector PK parameter Cmax/Clast, Phase 2 of the study.
Časové okno: Up to 24 months post-infusion.

Quantification of CT204V viral vector genomes (viral titer) in peripheral blood per PK parameter Cmax/Clast, central read.

Up to 24 months post-infusion.
Viral vector PK parameter Tmax/Tlast, Phase 2 of the study.
Časové okno: Up to 24 months post-infusion.

Quantification of CT204V viral vector genomes (viral titer) in peripheral blood per PK parameter Tmax/Tlast, central read.

Up to 24 months post-infusion.
Cellular Kinetics (CK) of CT204V CAR transgene parameter Cmax/Clast, Phase 2 of the study.
Časové okno: Up to 24 months post-infusion.

Quantification of CT204V CAR transgene levels in peripheral blood per CAR, transgene PK parameter Cmax/Clast, central read

Up to 24 months post-infusion.
Cellular Kinetics (CK) of CT204V CAR transgene parameter Tmax/Tlast, Phase 2 of the study.
Časové okno: Up to 24 months post-infusion.

Quantification of CT204V viral vector genomes (viral titer) in peripheral blood, central read, central read.

Up to 24 months post-infusion.
Viral vector PK parameter AUClast, Phase 2 of the study.
Časové okno: Up to 24 months post-infusion.

Quantification of CT204V viral vector genomes (viral titer) in peripheral blood per PK parameter AUClast, central read.

Up to 24 months post-infusion.
Objective Response Rate (Complete Response+Partial Response) per Lugano Classification, Phase 2 of the study.
Časové okno: Up to 24 months post-infusion.

To evaluate the preliminary antitumor activity of CT204V. ORR (CR+PR) per Lugano Classification based on ORR, central read.

Up to 24 months post-infusion.
Quantification of CT204V CAR transgene levels (copies/μg gDNA) in peripheral blood, Phase 2 of the study.
Časové okno: Up to 24 months post-infusion.

Quantification of CT204V CAR transgene levels (copies/μg gDNA) in peripheral blood, central read.

Up to 24 months post-infusion.
Quantification of CT204V viral vector genomes (viral titer) in peripheral blood, Phase 1 of the study.
Časové okno: Up to 24 months post-infusion.

Quantification of CT204V viral vector genomes (viral titer) in peripheral blood, central read, as assessed by the investigator.

Up to 24 months post-infusion.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

9. listopadu 2026

Primární dokončení (Odhadovaný)

15. října 2029

Dokončení studie (Odhadovaný)

15. října 2029

Termíny zápisu do studia

První předloženo

6. listopadu 2026

První předloženo, které splnilo kritéria kontroly kvality

6. listopadu 2026

První zveřejněno (Aktuální)

12. listopadu 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

12. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

6. listopadu 2026

Naposledy ověřeno

1. listopadu 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • R1055C00001

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Časový rámec sdílení IPD

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Kritéria přístupu pro sdílení IPD

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .