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CAR T-cell Therapy

CAR T-Cell Therapy + Ipilimumab for Non-Hodgkin's Lymphoma (CRETI-NH Trial)

Phase 1

Waitlist Available

Led By Carlos Ramos, MD

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

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

Must have

Recovered from the toxic effects of all prior chemotherapy before entering this study

Available autologous transduced peripheral blood T-cells with greater than/=15% expression of CD19CAR determined by flow-cytometry

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

CRETI-NH Trial Summary

This trial is testing a new cancer treatment that involves genetically modifying immune cells to attack the cancer.

Who is the study for?

This trial is for people with certain types of blood cancers like non-Hodgkin Lymphoma, Acute Lymphoblastic Leukemia, or Chronic Lymphocytic Leukemia that have returned or persisted despite treatment. Participants need to have a specific type of T-cell in their blood, be recovered from previous treatments, and meet certain health criteria including organ function and blood counts. Pregnant individuals or those with allergies to mouse proteins cannot join.Check my eligibility

What is being tested?

The study tests genetically modified T-cells combined with an antibody called anti-CD19 to fight cancer. These special cells are designed to better recognize and kill cancer cells by targeting CD19 on their surface. The trial aims to determine the highest safe dose, understand side effects, how long the T-cells last in the body, and if they're effective against lymphoma or leukemia.See study design

What are the potential side effects?

Potential side effects may include reactions related to immune response such as fever and fatigue; risk of infection; possible allergic reactions due to murine (mouse) protein components; issues from increased immune activity like inflammation in organs; plus typical risks associated with cell transfusions.

CRETI-NH Trial Eligibility Criteria

Inclusion Criteria

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

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I have recovered from side effects of my previous cancer treatments.

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My T-cells are modified to fight cancer and show more than 15% CD19CAR expression.

Select...

I can care for myself but may need occasional help.

CRETI-NH Trial 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

Adverse Event Data per Patient

Secondary outcome measures

Correlation of additional doses and cumulative rise in the percentage of circulating gene modified cells

Number of patients with tumor response

Survival and function of CD19CAR T cells

CRETI-NH Trial Design

1Treatment groups

Experimental Treatment

Group I: CD19CAR-28-zeta T cellsExperimental Treatment2 Interventions

Three dose levels of CTLs will be evaluated. Each patient will receive one injection according to their assigned dose over 1-10 minutes IV. *At the discretion of the attending physician, if after a 4 to 6-week evaluation period the patient has had apparent clinical benefit (as determined by symptoms, physical exam or radiological studies); repeat infusions separated by 4 to 6 weeks (up to a maximum of 3 extra doses) of modified T cells at the same dose level or below the patient's original dose can be administered.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ipilimumab

2014

Completed Phase 3

~2670

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Center for Cell and Gene Therapy, Baylor College of MedicineOTHER

111 Previous Clinical Trials

2,803 Total Patients Enrolled

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,002,166 Total Patients Enrolled

The Methodist Hospital Research InstituteOTHER

271 Previous Clinical Trials

80,361 Total Patients Enrolled

Media Library

CD19CAR-28-zeta T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00586391 — Phase 1

B-Cell Lymphoma Research Study Groups: CD19CAR-28-zeta T cells

B-Cell Lymphoma Clinical Trial 2023: CD19CAR-28-zeta T cells Highlights & Side Effects. Trial Name: NCT00586391 — Phase 1

CD19CAR-28-zeta T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00586391 — Phase 1

Frequently Asked Questions

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

Could you expound on the previous research conducted with CD19CAR-28-zeta T cells?

"Currently, 318 clinical trials are in progress which focus on the efficacy of CD19CAR-28-zeta T cells, 38 of those being Phase 3. Most research sites are located in Pittsburgh but there exists a total of 20362 locations across the world running studies related to this intervention."

Answered by AI

What maladies typically respond best to CD19CAR-28-zeta T cell treatments?

"CD19CAR-28-zeta T cells is often utilized to treat cutaneous melanoma, but it can additionally be employed for complete resection, liver carcinoma and metastatic melanoma."

Answered by AI

Are there any opportunities currently available to participate in this trial?

"This trial is temporarily closed to new candidates. It was first posted on February 1st, 2009 and the most recent edit occurred on February 10th 2022. Should you be interested in alternative studies, 2927 clinical trials for lymphoma, diffuse are currently recruiting subjects as well as 318 that involve CD19CAR-28-zeta T cells."

Answered by AI

What are the long-term effects of CD19CAR-28-zeta T cell treatment for humans?

"Using our internal scale, the safety of CD19CAR-28-zeta T cells is rated a 1 due to its Phase 1 status. This means that there is still limited data available on both efficacy and safety."

Answered by AI

How many participants are being recruited for this trial?

"This particular clinical trial is no longer actively recruiting participants - the posting was first published in February 2009, and last edited on the 10th of February 2022. In lieu of this study, there are 2927 studies related to lymphoma diffuse currently looking for volunteers as well as 318 CD19CAR-28-zeta T cell investigations seeking enrolment."

Answered by AI

Recent research and studies

BloodJournal

Xu, Yang, Ming Zhang, Carlos A. Ramos, April Durett, Enli Liu, Olga Dakhova, Hao Liu, et al.. 2014. “Closely Related T-memory Stem Cells Correlate with in Vivo Expansion of CAR.CD19-T Cells and Are Preserved by IL-7 and IL-15”. Blood. American Society of Hematology. doi:10.1182/blood-2014-01-552174.

clinicaltrials.govStudy

CD19 Chimeric Receptor Expressing T Lymphocytes In B-Cell Non Hodgkin's Lymphoma, ALL & CLL

Carlos Ramos 2009. "CD19 Chimeric Receptor Expressing T Lymphocytes In B-Cell Non Hodgkin's Lymphoma, ALL & CLL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00586391.

All > Childhood Leukemia