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CAR T-cell Therapy

TCRγδ T Cells + Blinatumomab for Blood Cancers

Phase 2

Recruiting

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

Study 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.Check my eligibility

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.See study design

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

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

Primary outcome measures

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

Secondary outcome measures

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

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

~1210

Cyclophosphamide

1995

Completed Phase 3

~3770

Fludarabine

2012

Completed Phase 3

~1100

G-CSF

2014

Completed Phase 4

~1610

Melphalan

2008

Completed Phase 3

~1500

Mesna

2003

Completed Phase 2

~1380

Rituximab

1999

Completed Phase 4

~1880

Tacrolimus

2011

Completed Phase 4

~4740

Thiotepa

2008

Completed Phase 3

~2150

HPC,A Infusion

2013

Completed Phase 2

~90

CliniMACS

2005

Completed Phase 3

~770

Sirolimus

2013

Completed Phase 4

~2750

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor

428 Previous Clinical Trials

5,306,561 Total Patients Enrolled

Brandon Triplett, MDPrincipal InvestigatorSt. Jude Children's Research Hospital

7 Previous Clinical Trials

1,323 Total Patients Enrolled

Media Library

TCRɑβ-depleted and CD45RA-depleted haploidentical donor progenitor cell transplantation (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02790515 — Phase 2

Acute Lymphoblastic Leukemia Research Study Groups: Treatment

Acute Lymphoblastic Leukemia Clinical Trial 2023: TCRɑβ-depleted and CD45RA-depleted haploidentical donor progenitor cell transplantation Highlights & Side Effects. Trial Name: NCT02790515 — Phase 2

TCRɑβ-depleted and CD45RA-depleted haploidentical donor progenitor cell transplantation (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02790515 — Phase 2

Frequently Asked Questions

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

Is this experiment still recruiting people who are interested in participating?

"The posted information on clinicaltrials.gov does show that this study is looking for patients right now. The trial was first advertised on July 14th, 2016 and has had updates as recently as July 22nd, 2022. They need a total of 52 individuals across 1 site."

Answered by AI

To what extent can G-CSF help patients suffering from ____?

"G-CSF is a medication that has been traditionally used to treat leukemia. Additionally, G-CSF can be given as treatment for patients with other conditions like lung cancers, organ transplantation, dermatitis, atopic."

Answered by AI

Does this research project follow in the footsteps of other G-CSF trials?

"As of right now, 1528 separate clinical trials are running in order to investigate the efficacy of G-CSF. This includes 285 Phase 3 trials. Even though a large proportion of these studies originate from Bethesda, Maryland, there are 41860 total locations worldwide where patients can receive this treatment."

Answered by AI

Has G-CSF been federally approved in the USA?

"There is some safety data available for G-CSF, but since this is only a Phase 2 trial, there is no evidence yet of efficacy. We've given it a score of 2."

Answered by AI

How many participants will this trial have in total?

"That is correct. The clinicaltrials.gov site lists this study as currently recruiting patients. This research, which was originally made public on July 14th 2016 and edited latest on July 22nd 2022, is looking for 52 individuals at 1 location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Provision of TCRγδ T Cells and Memory T Cells Plus Selected Use of Blinatumomab in Naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies Relapsed or Refractory Despite Prior Transplantation

2016. "Provision of TCRγδ T Cells and Memory T Cells Plus Selected Use of Blinatumomab in Naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies Relapsed or Refractory Despite Prior Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02790515.

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