Long-term Follow-up Study of Patients Receiving CAR-T Cells

October 30, 2023 updated by: Nirav Shah, Medical College of Wisconsin

This protocol is designed as a long-term follow-up study of participants who will receive CAR-T cells as part of a clinical trial at the Medical College of Wisconsin/ Froedtert Hospital. The clinical trials include the following:

Phase 1 Study of CAR-20/19-T Cells in Patients with Relapsed Refractory B Cell Malignancies (NCT03019055); Phase I Trial of BCMA-TGF-BETA CAR-T Cells in Relapsed, Refractory Myeloma (NCT05976555); CAR20.19.22 T-cells in Relapsed, Refractory B-cell Malignancies (NCT05094206); LV20.19 CAR T-Cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies (NCT05990465); CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell Malignancies (NCT04186520)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The objective is to follow participants receiving CAR-T cells from years 2 to 15 post-treatment for persistence of CAR-T cells, development of secondary malignancies, or other medical complications.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Medical College of Wisconsin Clinical Cancer Center
  • Phone Number: 414-805-8900
  • Email: cccto@mcw.edu

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Froedtert Hospital & Medical College of Wisconsin
        • Contact:
          • Cancer Center Clinical Trials Office
          • Phone Number: 414-805-8900
          • Email: cccto@mcw.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All participants who enrolled in a CAR-T study at Froedtert Hospital & the Medical College of Wisconsin.

Description

Inclusion Criteria:

  • All participants who enrolled in a CAR-T study at Froedtert Hospital & the Medical College of Wisconsin.

Exclusion Criteria:

  • There are no exclusion criteria for this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants who received CAR-T cells.
Participants who received CAR-T cells at Froedtert Hospital & the Medical College of Wisconsin in clinical trials (e.g., NCT05976555, NCT05094206, NCT05990465, NCT03019055 or NCT04186520).
Other: Long-Term Follow-Up of Participants who Received CAR-T cells
No study drug is administered in this study. Participants who received CAR-T cells in a previous trial will be evaluated in this trial for long-term safety and efficacy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the incidence of a new malignancy at 5 years.
Time Frame: Baseline to five years.
The number of subjects with new malignancy.
Baseline to five years.
Change from baseline in the incidence of a new malignancy at 10 years.
Time Frame: Baseline to 10 years.
The number of subjects with new malignancy.
Baseline to 10 years.
Change from baseline in the incidence of a new malignancy at 15 years.
Time Frame: Baseline to 15 years.
The number of subjects with new malignancy.
Baseline to 15 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the number of participants who are disease free two years post-infusion.
Time Frame: Two years post-infusion.
The number of subjects who relapse or progress among subjects who are disease free two years post-transplant.
Two years post-infusion.
Change from baseline in overall survival rate.
Time Frame: Every 6 months from years 2-5 post-infusion then yearly from year 6-15.
The number of subjects who are alive.
Every 6 months from years 2-5 post-infusion then yearly from year 6-15.
Change from baseline in the absolute B- and T-lymphocyte counts.
Time Frame: Every 6 months from years 2-5 post-infusion then yearly from year 6-15.
The number of cells measured by 10^3 cells/µL.
Every 6 months from years 2-5 post-infusion then yearly from year 6-15.
Change from baseline in the proportion of participants with persistent CAR-20/19-T cells.
Time Frame: Every 6 months from years 2-5 post-infusion then yearly from year 6-15.
The number of participants with persistent cells measured by by integrated vector DNA by quantitative polymerase chain reaction.
Every 6 months from years 2-5 post-infusion then yearly from year 6-15.
Change from baseline in the recovery of immunoglobulin production as measured by quantitative immunoglobulin levels.
Time Frame: Every 6 months from years 2-5 post-infusion then yearly from year 6-15.
This measure will be the serum concentration of Immunoglobin A (IgA), immunoglobin G (IgG) and immunoglobin M (IgM).
Every 6 months from years 2-5 post-infusion then yearly from year 6-15.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Investigators

  • Principal Investigator: Nirav Shah, Medical College of Wisconsin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Estimated)

January 1, 2035

Study Completion (Estimated)

January 1, 2035

Study Registration Dates

First Submitted

December 7, 2017

First Submitted That Met QC Criteria

December 14, 2017

First Posted (Actual)

December 18, 2017

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 30, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO30317

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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