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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMarcela V. Maus, M.D.,Ph.D.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provision of voluntary written informed consent by subject

CAR T cells were administered in HCC IRB or MGB IRB corresponding main study

Disqualifiers

None

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Disease assessments

    Diagnostic test

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

  • Tumor Biopsy

    Procedure/Surgery

    Tumor Biopsy per protocol

  • Blood test

    Diagnostic test

    Blood Test per protocol

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: CAR T cells3 interventions

Trial outcomes

Primary outcomes

1

Overall Survival

defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive

Time frame
1 month
2

Overall Survival

defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive

Time frame
6 months
3

Overall Survival

defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive

Time frame
12 months
4

Overall Survival

defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive

Time frame
24 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Massachusetts General Hospital

Sponsor institution