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CAR T-cell Therapy

TCRγδ T Cells + Blinatumomab for Blood Cancers

Phase 2

Waitlist Available

Led By Brandon Triplett, MD

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

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

Must have

If prior CNS leukemia, it must be treated and in CNS CR

At least single haplotype matched (≥ 3 of 6) family member

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year post transplant

Awards & highlights

No Placebo-Only Group

Summary

This trial is examining a treatment therapy that could reduce toxicity and relapse while promoting rapid immune reconstitution with limited serious graft-versus-host-disease (GVHD) for patients with hematologic malignancies.

Who is the study for?

This trial is for young people (≤21 years old) with certain blood cancers that didn't get better after a previous transplant. They need a family member who's at least a half-match as a donor, good heart and kidney function, not pregnant or breastfeeding, no other active cancers or uncontrolled infections, and able to perform some physical activities.

What is being tested?

The study tests if T-cell depleted bone marrow transplants from half-matched family donors can help patients without using radiation. It also checks the safety of adding Blinatumomab post-transplant in CD19+ cancer cases to see if it improves survival rates and reduces complications like GVHD.

What are the potential side effects?

Possible side effects include reactions to immune cells or drugs like Blinatumomab (fever, fatigue), organ damage due to chemotherapy agents used before the transplant, increased risk of infections because of weakened immunity, and graft-versus-host disease where donated cells attack the body.

Eligibility Criteria

Inclusion Criteria

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

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My previous brain leukemia is treated and currently in remission.

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I have a family member who is at least a half match for organ or tissue donation.

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My blood cancer returned or didn't respond after a stem cell transplant.

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I have a family member who is a partial match for a donation.

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I do not have any active cancer other than the one I am seeking treatment for.

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My kidney function, measured by creatinine clearance or GFR, is normal or near normal.

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My lung function is at least 40% of what is expected, or my oxygen level is 92% or higher without extra oxygen.

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My bilirubin levels are within the normal range for my age.

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I do not have any ongoing serious infections.

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I am 18 years old or older.

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I have been approved as a donor according to the required health guidelines.

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I am 21 years old or younger.

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I can do most activities but may need help.

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My liver enzymes are within 5 times the normal limit.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year post-transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year post-transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year post-transplant for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

The number of patients engrafted by day +30 post-transplant

Secondary study objectives

The cumulative incidence of acute and chronic Graft-Versus-Host Disease (GVHD)

The cumulative incidence of transplant related mortality

The estimate of cumulative incidence of relapse

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment13 Interventions

Participants receive a conditioning regimen of antithymocyte globulin (rabbit), cyclophosphamide, mesna, fludarabine, thiotepa, tacrolimus (first 5 participants enrolled), sirolimus (used beginning with 6th enrolled participant), melphalan, rituximab. This is followed by HPC,A infusion (transplant), then by G-CSF and blinatumomab. Cells for infusion are prepared using the CliniMACS System.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Anti-thymocyte globulin (rabbit)

2005

Completed Phase 2

~140

Blinatumomab

2014

Completed Phase 3

~1230