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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 november 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

160

Fase

  • Fase 2
  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: CT204V-CD19 × CD20

Experimental

Andere namen:
  • CT204V

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Adverse Events(AEs)/Serious Adverse Events (SAEs), Phase 1 of the study.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: Up to 24 months.

To assess the efficacy based on DoCR rate.
Up to 24 months.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Objective Response Rate (Complete Response+Partial Response) per Lugano Classification, Phase 1 of the study.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

AstraZeneca

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

9 november 2026

Primaire voltooiing (Geschat)

15 oktober 2029

Studie voltooiing (Geschat)

15 oktober 2029

Studieregistratiedata

Eerst ingediend

6 november 2026

Eerst ingediend dat voldeed aan de QC-criteria

6 november 2026

Eerst geplaatst (Werkelijk)

12 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 november 2026

Laatste update ingediend die voldeed aan QC-criteria

6 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • R1055C00001

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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.

IPD-tijdsbestek voor delen

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.

IPD-toegangscriteria voor delen

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.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren