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CAR T-cell Therapy

CAR T-cell Therapy for B-Cell Lymphoma

Phase 1

Recruiting

Led By Sattva Neelapu, MD

Research Sponsored by M.D. Anderson Cancer Center

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 through study completion; an average of 1 year

Awards & highlights

Study Summary

This trial tests a new type of cancer therapy to find the max dose that can be safely given to people with advanced B-cell lymphoma.

Who is the study for?

Adults with B-cell lymphomas that have come back or haven't responded to treatment can join this trial. They must be over 18, have a certain level of overall health and organ function, and at least one measurable lesion. Prior treatments should be completed with recovery from most side effects, except hair loss.Check my eligibility

What is being tested?

The trial is testing JV-213 CAR T cell therapy to find the highest dose patients can tolerate without severe side effects. Participants will undergo leukapheresis (a procedure to collect white blood cells) before receiving the therapy.See study design

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as fever, fatigue, and breathing difficulties; there may also be risks associated with leukapheresis like low blood pressure or dizziness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year 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 of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2 (dose expansion)Experimental Treatment2 Interventions

Participants will receive JV-213 at the recommended dose that was found in Part 1.

Group II: Part 1 (dose escalation)Experimental Treatment2 Interventions

Part 1, the dose of JV-213 participants receive will depend on when you join this study. Up to 3 dose levels of JV-213 will be tested. About 3-6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level of JV-213. Each new group will receive a higher dose of JV-213 than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of JV-213 is found.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Leukapheresis

2016

Completed Phase 2

~690

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,973 Previous Clinical Trials

1,789,313 Total Patients Enrolled

Sattva Neelapu, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Non-Hodgkin's Lymphoma Research Study Groups: Part 1 (dose escalation), Part 2 (dose expansion)

Non-Hodgkin's Lymphoma Clinical Trial 2023: JV-213 Highlights & Side Effects. Trial Name: NCT05773040 — Phase 1

Frequently Asked Questions

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

Has the FDA sanctioned Part 1 (dose escalation) of this trial?

"Given that this is a Phase 1 trial, which has limited safety and efficacy data available, our team at Power gave Part 1 of the study a score of 1 on its safety scale."

Answered by AI

Is this research still looking for participants?

"According to the clinicaltrials.gov database, this trial is no longer recruiting patients; The study was initially posted on August 31st 2023 and the last report of changes came through March 6th 2023. Conversely, a wide variety of other trials are currently enlisting participants at this moment in time - 1718 studies to be exact."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 1 Study of JV-213 Autologous CD79b-targeting Chimeric Antigen Receptor T-cell Therapy in Adults With Relapsed or Refractory B-cell Lymphomas

2023. "A Phase 1 Study of JV-213 Autologous CD79b-targeting Chimeric Antigen Receptor T-cell Therapy in Adults With Relapsed or Refractory B-cell Lymphomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05773040.