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

Study Purpose

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)

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03375619
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Medical College of Wisconsin
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Nirav Shah
Principal Investigator Affiliation Medical College of Wisconsin
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Chronic Lymphocytic Leukemia, Lymphomas Non-Hodgkin's B-Cell, Lymphoma, Small Lymphocytic, Mantle Cell Lymphoma, Central Nervous System Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Burkitt Lymphoma, Multiple Myeloma
Additional Details

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.

Arms & Interventions

Arms

: 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).

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Milwaukee, Wisconsin

Status

Recruiting

Address

Froedtert Hospital & Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

Site Contact

Cancer Center Clinical Trials Office

cccto@mcw.edu

414-805-8900