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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

Must not have

Clinically significant viral infection or uncontrolled viral reactivation of EBV, CMV, Adv, BK-virus, or HHV-6

CNS abnormalities: CNS-3 disease; History or presence of CNS disorder; Autoimmune disease with CNS involvement

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have an active significant viral infection.

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I have a central nervous system disorder or autoimmune disease affecting my brain.

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I am currently taking antibiotics for an infection.

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I have not had any cancer, except for certain types, in the last 2 years.

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I have severe graft-versus-host disease.

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My tumor is in a spot where it could block my airways if it gets bigger.

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I have heart issues like irregular heartbeat, recent heart attack, or severe heart dysfunction.

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I am currently infected with HIV.

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I am on a high dose of steroids for graft-versus-host disease.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose limiting toxicity (DLT) rate

Secondary study objectives

Overall Response Rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 16Eligibility criteria met