Long-term Follow-up of Subjects Treated With CAR T Cells

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Marcela V. Maus, M.D.,Ph.D.
Study ID
NCT05024175
Status
Recruiting
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Conditions

  • Adult
  • CAR-T
  • Disease-Free Survival
  • Duty to Follow Up
  • Long Term Adverse Effects
  • Overall Survival
  • Progression-Free Survival

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Disease assessments — DIAGNOSTIC_TEST
    CT (Computerized Tomography) scan or PET-CT (Positron Emission Tomography-Computerized Tomography) scans as per protocol
  • Tumor Biopsy — PROCEDURE
    Tumor Biopsy per protocol
  • Blood test — DIAGNOSTIC_TEST
    Blood Test per protocol

Study Details

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 (DF/HCC# 22-175) and NCT06026319 (DF/HCC# 23-474).

Key Dates

Start date
Aug 7, 2023
Status verified
Mar 2026
Primary completion
Aug 1, 2038
Completion
Aug 1, 2039

Study Design

Enrollment
45 participants (estimated)

Arms

  • Arm: CAR T cells
    * Eligibility to participate on this study if enrolled on a DF/HCC 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

Primary Outcome Measure

Overall Survival [ Time Frame: 1 month ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02115
Matthew J Frigault, MD
[email protected]
(617) 724-4000
Matthew J Frigault, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Massachusetts General Hospital· Boston, MA

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