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Långtidsuppföljning av försökspersoner som behandlats med CARv3-TEAM-E T-celler

28 september 2026 uppdaterad av: Marcela V. Maus, M.D.,Ph.D.

This is a single site, non-randomized, open-label, long-term safety and efficacy follow-up study for Phase 1 studies that evaluate the safety and efficacy of CAR T cells: NCT05660369 (HCC# 22-175), NCT06026319 (HCC# 23-474) and NCT NCT07388277 (MGB# 2025P003179.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

This is a long-term safety and efficacy follow-up study for subjects who have been treated with CAR T cells in corresponding Phase I main studies that evaluated the safety and efficacy of CAR T cells in subjects.

No investigational treatment will be administered in this study.

The FDA (2020) recommends long-term follow up for subjects treated with gene therapy drug products to monitor for delayed adverse events (AEs), as well as durability of clinical response.

Therefore, after monitoring of subjects in the main studies has been completed (24 months after CAR T cells infusion, or <24 months after CAR T cells infusion if subject terminated early due to disease progression or due to discontinuing corresponding main study for any reason), subjects will be asked to participate in a long-term follow-up study (LTFU).

Subjects will be followed for up to 15 years following their last CAR T cells infusion in the corresponding main study.

Studietyp

Observationell

Inskrivning (Beräknad)

45

Kontakter och platser

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

Studiekontakt

Studieorter

  • Förenta staterna
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02115
        • Rekrytering
        • Massachusetts General Hospital
        • Huvudutredare:
          • Matthew J Frigault, MD
        • 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

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Subjects will be asked to participate leading up to the last HCC or MGB corresponding main study visit

Beskrivning

Inclusion Criteria:

Subjects will be asked to participate leading up to the last HCC or MGB corresponding main study visit.

Subjects meeting the following criteria are eligible for study participation:

  • Provision of voluntary written informed consent by subject
  • CAR T cells were administered in HCC IRB or MGB IRB corresponding main study

Exclusion Criteria:

Subjects meeting the following criterion are to be excluded from study participation:

- Subject unable to comply with study requirements

Studieplan

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

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiv: PROSPECTIVE

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
CAR T cells
  • Eligibility to participate on this study if enrolled on an HCC IRB or MGB IRB corresponding main study and received infusion of CAR T cells
  • The research study procedures include evaluations and follow up visits: Timepoints of each evaluation and follow up visit- per protocol
  • Medical History/Physical Exam
  • Blood Test
  • Assessment of Disease: CT (Computerized Tomography) scan or PET-CT (Positron Emission Tomography-Computerized Tomography) scans.
  • Tumor biopsy.
  • Data Collection
  • Biobanking
Diagnostiskt test: Disease assessments

CT (Computerized Tomography) scan or PET-CT (Positron Emission Tomography-Computerized Tomography) scans as per protocol

Procedur: Tumor Biopsy

Tumor Biopsy per protocol

Diagnostiskt test: Blood test

Blood Test per protocol

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overall Survival
Tidsram: 1 month

defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive
1 month
Overall Survival
Tidsram: 6 months

defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive
6 months
Overall Survival
Tidsram: 12 months

defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive
12 months
Overall Survival
Tidsram: 24 months

defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive
24 months
Progresison Free Survival
Tidsram: 1 month

PFS is defined as the number of days from the day of CAR T cells treatment to the first documented disease progression or date of death, whichever occurs first. Patients who are lost to follow up without a known date of progression or death due to any cause will be censored in the analysis at the date of their last available tumor assessment.
1 month
Progresison Free Survival
Tidsram: 6 months

PFS is defined as the number of days from the day of CAR T cells treatment to the first documented disease progression or date of death, whichever occurs first. Patients who are lost to follow up without a known date of progression or death due to any cause will be censored in the analysis at the date of their last available tumor assessment.
6 months
Progresison Free Survival
Tidsram: 12 months

PFS is defined as the number of days from the day of CAR T cells treatment to the first documented disease progression or date of death, whichever occurs first. Patients who are lost to follow up without a known date of progression or death due to any cause will be censored in the analysis at the date of their last available tumor assessment.
12 months
Progresison Free Survival
Tidsram: 24 months

PFS is defined as the number of days from the day of CAR T cells treatment to the first documented disease progression or date of death, whichever occurs first. Patients who are lost to follow up without a known date of progression or death due to any cause will be censored in the analysis at the date of their last available tumor assessment.
24 months
New incidence or exacerbation of a pre-existing neurologic disorder or prior rheumatologic or other autoimmune disorder
Tidsram: Up to 15 Years

An annual physical exam will be conducted for surveillance of manifestations indicative of oncoretroviral diseases.
Up to 15 Years
New incidence of a hematologic disorder
Tidsram: up to 15 years

An annual physical exam will be conducted for surveillance of manifestations indicative of oncoretroviral diseases.
up to 15 years
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v 5.0
Tidsram: up to 15 years

NCI Common Terminology Criteria for Adverse Events (CTCAE)
up to 15 years
Vector-derived RCL
Tidsram: baseline and in 3 months, 6 months, and annually up to 15 years

Archiving of samples for potential detection of vector-derived RCL. RCL testing will be monitored at the central RCL lab (Indiana University) by a suitable qPCR assay for detection of the lentiviral vector (VSV-g DNA).
baseline and in 3 months, 6 months, and annually up to 15 years
Assessment of CAR T cells persistence by VCN in peripheral blood
Tidsram: baseline and in 3 months, 6 months, every 6 months up to 5 years, and annually up to 15 years

VCN will be performed in DNA from whole blood to monitor for persistence of vector sequence
baseline and in 3 months, 6 months, every 6 months up to 5 years, and annually up to 15 years
Progression-free Survival
Tidsram: From post-CAR T cells infusion date until date of first documented disease progression or date of death from any cause, assessed up to 15 years post treatment

The number of days from the day of CAR T cells treatment to the first documented disease progression or date of death, whichever occurs first. Patients who are lost to follow up without a known date of progression or death due to any cause will be censored in the analysis at the date of their last available tumor assessment.
From post-CAR T cells infusion date until date of first documented disease progression or date of death from any cause, assessed up to 15 years post treatment
Overall Survival
Tidsram: From post-CAR T cells infusion date until documented date of death from any cause, assessed post treatment every 6 months through 5 years and then annually up to 15 years

The time from post-CAR T cells infusion to the date of death.
From post-CAR T cells infusion date until documented date of death from any cause, assessed post treatment every 6 months through 5 years and then annually up to 15 years

Samarbetspartners och utredare

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

Sponsor

Marcela V. Maus, M.D.,Ph.D.

Utredare

  • Huvudutredare: Matthew J Frigault, MD, Massachusetts General Hospital

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 (Faktisk)

7 augusti 2023

Primärt slutförande (Beräknad)

1 augusti 2038

Avslutad studie (Beräknad)

1 augusti 2039

Studieregistreringsdatum

Först inskickad

23 augusti 2021

Först inskickad som uppfyllde QC-kriterierna

23 augusti 2021

Första postat (Faktisk)

27 augusti 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 20-721

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

The Harvard Cancer Consortium (HCC) encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Tidsram för IPD-delning

Data can be shared no earlier than 1 year following the date of publication

Kriterier för IPD Sharing Access

Contact the Partners Innovations team at http://www.partners.org/innovation

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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