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CAR T-cell Therapy

CLBR001 CAR-T for Non-Hodgkin's Lymphoma

Phase 1

Waitlist Available

Led By Carolyn Mulroney, M.D.

Research Sponsored by Calibr, a division of Scripps Research

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

Study Summary

This trial is designed to study the long-term effects of receiving genetically modified autologous CLBR001 CAR-T cells.

Who is the study for?

This trial is for patients who have received at least one dose of CLBR001 CAR-T cells for various types of B-cell lymphomas and leukemias. Participants must be able to give informed consent and follow the study's visit schedule and requirements.Check my eligibility

What is being tested?

The study follows up long-term with patients treated with genetically modified autologous CLBR001 CAR-T cells, possibly in combination with SWI019, to monitor ongoing effects after their initial treatment.See study design

What are the potential side effects?

While specific side effects are not listed here, typical CAR-T therapy side effects can include cytokine release syndrome (flu-like symptoms), neurological events, low blood cell counts, infection risk increase, and infusion-related reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence and duration of new adverse events, late onset adverse events, and events of special interest

Incidence and duration of new serious adverse events

Incidence of new malignancies

+1 more

Secondary outcome measures

Detectable replication competent lentivirus (RCL)

Duration of detection of ADA for CLBR001 and SWI019

Duration of response

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: CLBR001 treated patientsExperimental Treatment1 Intervention

Patients who have been administered with CLBR001

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Calibr, a division of Scripps ResearchLead Sponsor

5 Previous Clinical Trials

221 Total Patients Enrolled

Carolyn Mulroney, M.D.Principal InvestigatorUniversity of California, San Diego

Media Library

CLBR001 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04488354 — Phase 1

Follicular Lymphoma Research Study Groups: CLBR001 treated patients

Follicular Lymphoma Clinical Trial 2023: CLBR001 Highlights & Side Effects. Trial Name: NCT04488354 — Phase 1

CLBR001 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04488354 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What objectives is this investigation attempting to fulfill?

"This long-term trial will evaluate how effective CLBR001 is at resolving adverse events, serious adverse events and duration that began in previous treatment protocols. Secondary measures include the number of CAR+ cells in blood, bone marrow and/or tissue specimens, detectable replication competent lentivirus (RCL), as well as an overall response determined by Response Evaluation Criteria In Lymphoma (RECIL) 2017 standards."

Answered by AI

Are there a significant number of health care facilities conducting this research experiment in the region?

"This research study is currently enrolling patients across 8 locations, with choices located in Duarte, Nashville and San Antonio. To minimize any additional travel demands on participants it is important to select the clinic that is closest to you."

Answered by AI

Have CLBR001 and SWI019 been sanctioned by the FDA?

"Our evaluation yielded a safety score of 1 for CLBR001 and SWI019, given that this is an early-stage trial where no or little information exists regarding their efficacy and risk profile."

Answered by AI

Are there any slots remaining for participants in this experiment?

"Unfortunately, the information located on clinicaltrials.gov confirms that this particular trial is not presently recruiting patients; the posting was initially put up on January 21st 2021 and last modified July 26th 2022. However, there are 1954 other trials welcoming participants at this time."

Answered by AI

Recent research and studies

Proceedings of the National Academy of SciencesJournal

Switchable Control over in Vivo CAR T Expansion, B Cell Depletion, and Induction of Memory

Viaud, Sophie, Jennifer S. Y. Ma, Ian R. Hardy, Eric N. Hampton, Brent Benish, Lance Sherwood, Vanessa Nunez, et al.. 2018. “Switchable Control over in Vivo CAR T Expansion, B Cell Depletion, and Induction of Memory”. Proceedings of the National Academy of Sciences. Proceedings of the National Academy of Sciences. doi:10.1073/pnas.1810060115.

Proceedings of the National Academy of SciencesJournal

Switch-mediated Activation and Retargeting of CAR-T Cells for B-cell Malignancies

Rodgers, David T., Magdalena Mazagova, Eric N. Hampton, Yu Cao, Nitya S. Ramadoss, Ian R. Hardy, Andrew Schulman, et al.. 2016. “Switch-mediated Activation and Retargeting of CAR-T Cells for B-cell Malignancies”. Proceedings of the National Academy of Sciences. Proceedings of the National Academy of Sciences. doi:10.1073/pnas.1524155113.

clinicaltrials.govStudy

Long-term Follow-up Study for Patients Treated With CLBR001 CAR-T

2021. "Long-term Follow-up Study for Patients Treated With CLBR001 CAR-T". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04488354.

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