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CAR T-cell Therapy

CAR T-Cell Therapy for Lymphoma

Phase 1

Waitlist Available

Led By Stephen J Schuster

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

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

Must have

Previous complete response to CAR T-cells with a duration ≥ 6 months (defined as 168 days)

Diffuse Large B-Cell Lymphoma or Follicular lymphoma, previously identified as CD19+

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at time of consent through 1 year after the subject received ctl019/ctl119

Awards & highlights

Study Summary

This trial will test if a treatment can help people with a certain type of cancer that has come back.

Who is the study for?

This trial is for adults with B-cell lymphomas who've had a good response to previous CAR T-cell therapy (CTL019/CTL119) lasting at least 6 months. They should have no other curative options and a limited prognosis. Key health requirements include normal liver function, decent heart function, and stable performance status.Check my eligibility

What is being tested?

The study tests the effects of reusing CTL019/CTL119 cells in patients whose B-cell lymphoma has relapsed late after initial successful treatment. It's for those who previously participated in UPCC13413/NCT02030834 and still have their manufactured product available.See study design

What are the potential side effects?

Potential side effects may include immune system reactions, changes in blood counts, fatigue, fever, difficulty breathing, and neurological events like confusion or seizures due to the body's reaction to the reintroduced T cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had a successful CAR T-cell treatment lasting at least 6 months.

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My lymphoma is CD19 positive.

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I am 18 years old or older.

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I am fully active or can carry out light work.

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I have no cure options left and my expected survival is less than 2 years with current treatments.

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My lymphoma can be measured or assessed, and I am not in complete remission.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at time of consent through 1 year after the subject received ctl019/ctl119

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at time of consent through 1 year after the subject received ctl019/ctl119

This trial's timeline: 3 weeks for screening, Varies for treatment, and at time of consent through 1 year after the subject received ctl019/ctl119 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Secondary outcome measures

Overall response rate using Cheson 2007 criteria

Trial Design

1Treatment groups

Experimental Treatment

Group I: Retreatment with CTL019/CTL119Experimental Treatment1 Intervention

All subjects will receive retreatment with CTL019/CTL119 and be followed per the schedule of procedures.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,000 Previous Clinical Trials

42,880,076 Total Patients Enrolled

Stephen J SchusterPrincipal InvestigatorUniversity of Pennsylvania

Media Library

CTL019/CTL119 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04419909 — Phase 1

B-Cell Lymphoma Research Study Groups: Retreatment with CTL019/CTL119

B-Cell Lymphoma Clinical Trial 2023: CTL019/CTL119 Highlights & Side Effects. Trial Name: NCT04419909 — Phase 1

CTL019/CTL119 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04419909 — Phase 1

Frequently Asked Questions

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

Has past research been conducted on CD19 redirected autologous T cells (CTL019 or CTL119 cells) as part of clinical studies?

"Presently, 16 clinical trials for CD19 redirected autologous T cells (CTL019 or CTL119 cells) are underway in the United States of America. 2 of these studies have passed Phase 3 and are currently recruiting participants from 296 different sites based mainly around Washington, District of Columbia."

Answered by AI

To what extent is this clinical trial being participated in by patients?

"Patient recruitment for this medical trial has since been concluded. Its initial posting was on February 1st 2023 and its last update occurred on August 30th 2022. Luckily, there are still 1739 trials looking to recruit individuals with lymphoma-B cell and 16 studies searching for patients who will receive CTL019 or CTL119 cells therapy."

Answered by AI

Are there any known risks associated with CD19 redirected autologous T cells (CTL019 or CTL119) therapy?

"Considering the limited data that exists on the safety and effectiveness of CD19 redirected autologous T cells (CTL019 or CTL119 cells), our team assigned it a score of 1."

Answered by AI

Is this particular research endeavor unprecedented?

"Since 2015, CD19 redirected autologous T cells (CTL019 or CTL119 cells) has been closely monitored by medical professionals and Novartis Pharmaceuticals. After their initial 115-patient study in 2015, Phase 2 drug approval was granted for this intervention. Currently there are 16 active trials related to these T Cells being conducted across 22 countries and 114 cities around the world."

Answered by AI

Are there any openings in this medical trial currently available?

"Based on clinicaltrials.gov, this research project is not currently recruiting patients even though it was first posted in February 1st of 2023 and most recently edited August 30th 2022. However, there are a plethora of other trials actively looking for participants right now with 1755 initiatives open around the world."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Retreatment With CTL019/CTL119

2024. "Retreatment With CTL019/CTL119". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04419909.