Recruiting

CAR T Cells

Sponsor:

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

Code:

NCT05024175

Conditions

Long Term Adverse Effects

CAR-T

Duty to Follow Up

Adult

Progression-Free Survival

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Disease assessments

Tumor Biopsy

Blood test

Study Details

Brief summary:

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).

Conditions

Long Term Adverse Effects

CAR-T

Duty to Follow Up

Adult

Progression-Free Survival

Study ID

NCT05024175

Start date

Aug 7, 2023

Status verified date

Mar, 2026

Completion date

Aug 1, 2039

Anticipated

Primary completion date

Aug 1, 2038

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Subjects will be asked to participate leading up to the last DF/HCC 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 DF/HCC 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

Study Design

Enrollment

45 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

Disease assessments

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

Tumor Biopsy

Tumor Biopsy per protocol

Blood test

Blood Test per protocol

Primary outcome measure

  • Overall Survival [ Time Frame: 1 month ]
  • Overall Survival [ Time Frame: 6 months ]
  • Overall Survival [ Time Frame: 12 months ]
  • Overall Survival [ Time Frame: 24 months ]
  • Progresison Free Survival [ Time Frame: 1 month ]
  • Progresison Free Survival [ Time Frame: 6 months ]
  • Progresison Free Survival [ Time Frame: 12 months ]
  • Progresison Free Survival [ Time Frame: 24 months ]
  • New incidence or exacerbation of a pre-existing neurologic disorder or prior rheumatologic or other autoimmune disorder [ Time Frame: Up to 15 Years ]
  • New incidence of a hematologic disorder [ Time Frame: up to 15 years ]
  • Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v 5.0 [ Time Frame: up to 15 years ]
  • Vector-derived RCL [ Time Frame: baseline and in 3 months, 6 months, and annually up to 15 years ]
  • Assessment of CAR T cells persistence by VCN in peripheral blood [ Time Frame: baseline and in 3 months, 6 months, every 6 months up to 5 years, and annually up to 15 years ]
  • Progression-free Survival [ Time Frame: 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 [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Matthew J Frigault, MD

617-643-6175mfrigault@mgb.org

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Matthew J Frigault, MD

(617) 724-4000mfrigault@mgb.org

Principal Investigator:

Matthew J Frigault, MD

More Information

Sponsor

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

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

Keywords

  • Long-Term Follow-up to CAR-T Cells
  • Follow-up Studies

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Marcela V. Maus, M.D.,Ph.D. on 2026-03-16.