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
Apply to this trial

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

First listed
Aug 27, 2021
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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