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CAR T-cell Therapy

CAR T-Cell Therapy for Lymphoma (MAGENTA Trial)

Phase 1

Recruiting

Led By Rayne Rouce, 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

Suitable for allogeneic hematopoietic stem cell transplant (HSCT) with confirmed eligible donor

CD5-positive tumor with >50% CD5 + blasts by flow cytometry or immunohistochemistry

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks pre-infusion and 6 weeks post-infusion

Awards & highlights

MAGENTA Trial Summary

This trial is testing a new way to fight cancer by combining two existing methods, antibodies and T-cells. Antibodies are proteins that protect the body from disease, and T-cells are special blood cells that can kill other cells, including tumor cells.

Who is the study for?

This trial is for people under 75 with certain T-cell blood cancers who haven't responded to other treatments. They should have a life expectancy over 12 weeks, be at least two months post-transplant if applicable, and not currently on certain medications or have severe active infections.Check my eligibility

What is being tested?

The study tests modified T-cells with a special receptor (CD5.CAR/28zeta) designed to target cancer cells in patients with specific types of T-cell leukemia or lymphoma. It's seeing how well these engineered T-cells work and how long they last in the body.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 due to weakened immunity from the treatment, and possible allergic reactions to mouse protein used in the therapy.

MAGENTA Trial Eligibility Criteria

Inclusion Criteria

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

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I am a candidate for a stem cell transplant and have a confirmed donor.

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My tumor is CD5 positive with more than half of the cells being CD5 positive.

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I have a donor for EBV-specific T cell treatment.

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I have never had a bone marrow transplant or my cancer returned after one.

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My cancer returned after a stem cell transplant from a donor.

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I have been diagnosed with a type of T-cell leukemia or lymphoma.

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I am 75 years old or younger.

MAGENTA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks pre-infusion and 6 weeks post-infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks pre-infusion and 6 weeks post-infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks pre-infusion and 6 weeks post-infusion for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Dose limiting toxicity (DLT) rate

Secondary outcome measures

Overall Response Rate

MAGENTA Trial Design

2Treatment groups

Experimental Treatment

Group I: Autologous CD5.CAR/28zeta CAR T cells (Group A)Experimental Treatment1 Intervention

Three dose levels will be evaluated. The T cells will be administered with Cytoxan and fludarabine.If patients have experienced either a partial response or stable disease and completed the 6 week toxicity evaluation without evidence of DLT or other infectious complications, they will be eligible to receive up to 3 additional infusions of CD5 CAR.T cells. Patients remain eligible for up to 3 additional infusions as long as they continue to have a clinical response and absence of safety concerns. If patients experience a complete response following an additional infusion, investigators will recommend they proceed to allogeneic HSCT. Once dose escalation is completed, the trial will be expanded and treat up to an additional 6 patients (2 cohorts) at the MTD in each group to gather additional safety data and preliminary efficacy data.

Group II: Allogeneic CD5.CAR/28zeta CAR T cells (Group B)Experimental Treatment1 Intervention

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,002,170 Total Patients Enrolled

Center for Cell and Gene Therapy, Baylor College of MedicineOTHER

111 Previous Clinical Trials

2,775 Total Patients Enrolled

The Methodist Hospital Research InstituteOTHER

274 Previous Clinical Trials

80,493 Total Patients Enrolled

Media Library

Allogeneic CD5.CAR/28zeta CAR T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03081910 — Phase 1

Acute Lymphoblastic Leukemia Research Study Groups: Allogeneic CD5.CAR/28zeta CAR T cells (Group B), Autologous CD5.CAR/28zeta CAR T cells (Group A)

Acute Lymphoblastic Leukemia Clinical Trial 2023: Allogeneic CD5.CAR/28zeta CAR T cells Highlights & Side Effects. Trial Name: NCT03081910 — Phase 1

Allogeneic CD5.CAR/28zeta CAR T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03081910 — Phase 1

Frequently Asked Questions

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

Is enrollment for this medical experiment currently active?

"Affirmative. According to clinicaltrials.gov, this medical trial was published on November 1st 2017 and most recently amended on July 25th 2022. Currently, 42 patients need to be enrolled from two different centres of care."

Answered by AI

What have been the previous investigations concerning Allogeneic CD5.CAR/28zeta CAR T cells?

"Currently, 889 clinical trials are in process to assess Allogeneic CD5.CAR/28zeta CAR T cells with 161 of them being Phase 3 studies. While the majority of these examinations are occurring in Philadelphia, Pennsylvania, 28443 distinct sites have been established for trialing Allogeneic CD5.CAR/28zeta CAR T cells."

Answered by AI

What medical conditions do Allogeneic CD5.CAR/28zeta CAR T cells typically target?

"Allogeneic CD5.CAR/28zeta CAR T cells is usually taken to ameliorate multiple sclerosis, but can also be effective in treating mixed-cell type lymphoma, acute myelocytic leukemia, and retinoblastoma."

Answered by AI

What is the current capacity of patients for this research trial?

"Absolutely, the info posted on clinicaltrials.gov points to this research project being actively recruitng participants. It was initially announced 11/1/2017 and has been updated most recently on 7/25/2022 with an aim of enlisting 42 people at 2 different sites."

Answered by AI