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CAR T-cell Therapy

TMhuCART19-IL18 for Non-Hodgkin's Lymphoma

Phase 1

Recruiting

Led By Jakub Svaboda, MD

Research Sponsored by University of Pennsylvania

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 tests a new type of cancer treatment that assesses safety, how it works in the body, and how effective it is. It will be done in two parts to determine the best dose level.

Who is the study for?

This trial is for individuals with CD19+ cancers, such as Non-Hodgkin's Lymphoma. Participants must have proper kidney and liver function, no active graft-versus-host disease or need for immunosuppression post-transplant, stable breathing capacity, and evidence of active cancer within the last 12 weeks. They should not be on dialysis or have severe heart issues.Check my eligibility

What is being tested?

The study tests TmCD19-IL18 CAR T cells to find a safe dose level and assess its safety, tolerability, manufacturing feasibility, pharmacokinetics (how the drug moves through the body), and initial effectiveness in treating CD19+ cancers using a two-phase approach: Dose-Finding followed by Dose Expansion.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include typical reactions to CAR T-cell therapies like fever, fatigue, immune system reactions affecting different organs (cytokine release syndrome), neurological events among others.

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

Determination of maximum tolerated dose (MTD)

Incidence of Adverse Events as assessed by CTCAE v5.0

Number of subjects with dose limiting toxicities (DLTs)

Secondary outcome measures

Best overall response (BOR)

Characterize low level disease and B cell assessment in response to TmCD19-IL18 CAR T cells

Duration of response (DOR)

+4 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: NHL Dose Level 3Experimental Treatment1 Intervention

7x10^7 TmCD19-IL18 cells administered as a single intravenous (IV) infusion

Group II: NHL Dose Level 2Experimental Treatment1 Intervention

3x10^7 TmCD19-IL18 cells administered as a single intravenous (IV) infusion

Group III: NHL Dose Level 1Experimental Treatment1 Intervention

7x10^6 TmCD19-IL18 cells administered as a single intravenous (IV) infusion

Group IV: NHL Dose Level -1Experimental Treatment1 Intervention

3x10^6 TmCD19-IL18 cells administered as a single intravenous (IV) infusion

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Kite, A Gilead CompanyIndustry Sponsor

43 Previous Clinical Trials

3,632 Total Patients Enrolled

University of PennsylvaniaLead Sponsor

2,005 Previous Clinical Trials

42,882,263 Total Patients Enrolled

Jakub Svaboda, MDPrincipal InvestigatorUniversity of Pennsylvania

Frequently Asked Questions

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

Are there opportunities for individuals to participate in this clinical trial at the moment?

"Affirmative. The clinical trial page on the website of clinicaltrials.gov states that this medical study, which was initially posted on November 9th 2023 is actively recruiting participants. 24 volunteers are needed to be recruited from 1 site."

Answered by AI

Has the FDA sanctioned NHL Dose Level 1?

"Given the preliminary nature of Phase 1 studies, our team has given NHL Dose Level 1 a safety rating of 1. There is minimal data to support both its efficacy and safety at this time."

Answered by AI

How many participants are being monitored in this experiment?

"Affirmative. The information contained on clinicaltrials.gov states that this study is currently recruiting participants, which was initially posted on November 9th 2023 and subsequently updated a few days later. A total of 24 patients are required between 1 medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

TmCD19-IL18 in CD19+ Cancers

2023. "TmCD19-IL18 in CD19+ Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05989204.