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CAR T-cell Therapy

CD19 CAR-T Cells for Leukemia and Lymphoma (MULTIPRAT Trial)

Q: What diseases does CD19CAR/virus specific T cell therapy target?

<p>To address <a href="https://www.withpower.com/clinical-trials/pain">pain</a>, doctors will often use CD19CAR/virus specific T cells. This medication is also beneficial for ameliorating catarrh, rhinorrhoea, and musculoskeletal discomfort.</p>

Phase 1

Waitlist Available

Led By Carlos A 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

Any patient regardless of sex or age with CD19+ B-CLL or NHL undergoing allogeneic HSCT (Group B)

Available allogeneic CD19CAR transduced tri-virus-specific cytotoxic T lymphocytes with greater than or equal to15% expression of CD19CAR determined by flow-cytometry and greater than 10% killing of one or more viral antigen pulsed targets in a cytotoxicity assay at an effector:target ratio of 20:1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

MULTIPRAT Trial Summary

This trial is testing a new treatment for leukemia and lymphoma that uses a combination of two types of blood cells, T cells and antibodies. The hope is that this will be a more effective treatment with fewer side effects than current treatments.

Who is the study for?

This trial is for patients of any age and sex with CD19+ B-ALL or B-CLL/NHL undergoing a bone marrow transplant. They must have a life expectancy of at least 6 weeks, be able to consent, and use effective birth control post-treatment. Excluded are those with severe allergies to murine proteins, active GVHD above grade II, pregnancy, lactation, or severe infections.Check my eligibility

What is being tested?

The study tests T cells modified with an anti-CD19 chimeric receptor (CD19CAR) against leukemia/lymphoma post-transplant. It aims to find the highest safe dose of these T cells while assessing side effects and their longevity in preventing relapse and infections.See study design

What are the potential side effects?

Potential side effects include reactions related to immune response such as inflammation in various organs due to the modified T cells' activity. There may also be typical infusion-related reactions like fever or chills from Benadryl/Tylenol administration.

MULTIPRAT Trial Eligibility Criteria

Inclusion Criteria

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

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I have B-CLL or NHL with CD19+ and am getting a stem cell transplant from a donor.

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My treatment involves a specific immune cell therapy targeting CD19.

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I do not have leukemia or lymphoma after my stem cell transplant.

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My liver and kidney functions are within the required limits, and my hemoglobin is above 8.0.

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I am able to live with some level of independence.

MULTIPRAT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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

Number of dose limiting toxicities

Secondary outcome measures

Frequency of CD19+ B-Cells post HSCT expressing gene-modified CTLs

Frequency of T-cells expressing gene-modified CTLs.

Tumor response to gene modified CTL on measurable disease.

MULTIPRAT Trial Design

4Treatment groups

Experimental Treatment

Group I: Group B without diseaseExperimental Treatment2 Interventions

CD19+ B cell CLL or NHL undergoing allogeneic HSCT, without detectable disease post-HSCT Patients will receive CD19CAR/virus specific T cells - Dose Level 1: 1.5 x 10^7/m2 Patients will be evaluated in the clinic and a single dose of CTL will be administered from day +30 post-HSCT. Patients may be premedicated with Benadryl and Tylenol before receiving the injection of cells.

Group II: Group B with diseaseExperimental Treatment2 Interventions

CD19+ B cell CLL or NHL undergoing allogeneic HSCT, with minimal residual disease or relapse post-HSCT Patients will receive one of the following dose levels of CD19CAR/virus specific T cells: Dose Level 1: 1.5 x 10^7/m2 Dose Level 2: 4.5 x 10^7/m2 Dose Level 3: 1.2 x 10^8/m2 Patients will be evaluated in the clinic and a single dose of CTL will be administered from day +30 post-HSCT. Patients may be premedicated with Benadryl and Tylenol before receiving the injection of cells. If patients with relapse have a partial response or have stable disease they will be eligible to receive up to 6 further doses of CTLs, each of which will consist of the same number or less than as their first injection.

Group III: Group A without diseaseExperimental Treatment2 Interventions

CD19+ B-ALL undergoing allogeneic HSCT, without detectable disease post-HSCT. Patients will receive CD19CAR/virus specific T cells - Dose Level 1: 1.5 x 10^7/m2 Patients will be evaluated in the clinic and a single dose of CTL will be administered from day +30 post-HSCT. Patients may be premedicated with Benadryl and Tylenol before receiving the injection of cells.

Group IV: Group A with diseaseExperimental Treatment2 Interventions

CD19+ B-ALL undergoing allogeneic HSCT, with minimal residual disease or relapse post-HSCT Patients will receive one of the following dose levels of CD19CAR/virus specific T cells: Dose Level 1: 1.5 x 10^7/m2 Dose Level 2: 4.5 x 10^7/m2 Dose Level 3: 1.2 x 10^8/m2 Patients will be evaluated in the clinic and a single dose of CTL will be administered from day +30 post-HSCT. Patients may be premedicated with Benadryl and Tylenol before receiving the injection of cells. If patients with relapse have a partial response or have stable disease they will be eligible to receive up to 6 further doses of CTLs, each of which will consist of the same number or less than as their first injection.

0 / 5Eligibility 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

2,749 Total Patients Enrolled

The Methodist Hospital Research InstituteOTHER

271 Previous Clinical Trials

80,307 Total Patients Enrolled

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,002,112 Total Patients Enrolled

Media Library

CD19CAR/virus specific T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00840853 — Phase 1

Chronic Lymphocytic Leukemia Research Study Groups: Group A with disease, Group B with disease, Group B without disease, Group A without disease

Chronic Lymphocytic Leukemia Clinical Trial 2023: CD19CAR/virus specific T cells Highlights & Side Effects. Trial Name: NCT00840853 — Phase 1

CD19CAR/virus specific T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00840853 — Phase 1

Frequently Asked Questions

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

Have researchers conducted any other experiments involving CD19CAR/virus specific T cells?

"At present, there are 104 separate medical studies examining the efficacy of CD19CAR/virus specific T cells. Of those active trials, 30 have already reached phase 3. Although most research on this topic is conducted in Taichung and Florida, 1087 other clinics across the world are also running similar investigations."

Answered by AI

What diseases does CD19CAR/virus specific T cell therapy target?

"To address pain, doctors will often use CD19CAR/virus specific T cells. This medication is also beneficial for ameliorating catarrh, rhinorrhoea, and musculoskeletal discomfort."

Answered by AI

How many individuals are being included in the research project?

"At the present moment, enrollment in this trial is closed. It was initially listed on April 1st 2009 and last updated on August 8th 2022. If you are pursuing other trials, 1969 studies for chronic lymphocytic leukemia (CLL) are currently searching for participants as well as 104 CD19CAR/virus specific T cell endeavors."

Answered by AI

Is the enrollment period for this research still open?

"At this juncture, the trial is not accepting new patients. It was initially posted on April 1st 2009 and modified most recently on August 8th 2022. If other studies are of interest, there exist 1969 trials recruiting for chronic lymphocytic leukemia (CLL) and 104 clinical tests enrolling participants with CD19CAR/virus specific T cells."

Answered by AI

Is the utilization of CD19CAR/virus specific T cells sanctioned by the FDA?

"Our team's assessment of CD19CAR/virus specific T cells' safety ranked it as a 1 since this is only the initial phase of testing, thereby limiting existing evidence for efficacy and security."

Answered by AI

Recent research and studies

BloodJournal

Infusion of Donor-derived Cd19-redirected Virus-specific T Cells for B-cell Malignancies Relapsed After Allogeneic Stem Cell Transplant: A Phase 1 Study

Cruz, Conrad Russell Y., Kenneth P. Micklethwaite, Barbara Savoldo, Carlos A. Ramos, Sharon Lam, Stephanie Ku, Oumar Diouf, et al.. 2013. “Infusion of Donor-derived Cd19-redirected Virus-specific T Cells for B-cell Malignancies Relapsed After Allogeneic Stem Cell Transplant: A Phase 1 Study”. Blood. American Society of Hematology. doi:10.1182/blood-2013-06-506741.

clinicaltrials.govStudy

Multi-virus CTLs Expressing CD19 Chimeric Receptors, CD19 Positive Malignancies Post SCT, MULTIPRAT

Carlos Ramos 2009. "Multi-virus CTLs Expressing CD19 Chimeric Receptors, CD19 Positive Malignancies Post SCT, MULTIPRAT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00840853.

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