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CAR T-cell Therapy

Adoptive Immunotherapy for Blood Cancer Relapse After Transplant

Phase 1

Waitlist Available

Led By Leo Luznik, MD

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

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

Must have

Off all immunosuppressive drugs for 2 weeks prior to the PTCy-MILs collection.

Age ≥18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial is testing a new way to treat cancer using a patient's own cells. Doctors will take some of the patient's bone marrow, expand it, and then put it back in the patient to help fight their cancer.

Who is the study for?

This trial is for adults over 18 who've had a bone marrow relapse of blood cancer at least 6 months after an allogeneic cell transplant using PTCy. They should be off immunosuppressants for two weeks, have reasonable organ function, and no severe active GVHD or recent high-dose immunosuppression.Check my eligibility

What is being tested?

The study tests the safety of reinfusing activated marrow infiltrating lymphocytes (MILs) in patients with relapsed hematologic malignancies post-transplant. These MILs are expanded outside the body and then given back to help fight the cancer without causing severe GVHD.See study design

What are the potential side effects?

Potential side effects may include reactions related to immune activation such as fever or fatigue, complications from bone marrow aspiration, and risks associated with salvage therapy received during MIL expansion.

Eligibility Criteria

Inclusion Criteria

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

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I haven't taken any immunosuppressive drugs for at least 2 weeks.

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I am 18 years old or older.

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I am mostly able to care for myself and carry out daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

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

Feasibility of generating activated marrow infiltrating lymphocytes (MILs) from participants previously treated with post-transplantation cyclophosphamide (PTCy) (PTCy-MILs) who have relapsed disease involving the bone marrow

Secondary outcome measures

Clinical Response

Immunologic characterization of the PTCy-MIL product before and after expansion

Number of participants who experience chronic GVHD

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: MILs treatmentExperimental Treatment1 Intervention

Patients treated with the activated PTCy-MILs

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH

2,698 Previous Clinical Trials

7,492,472 Total Patients Enrolled

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor

558 Previous Clinical Trials

32,893 Total Patients Enrolled

Leo Luznik, MDPrincipal InvestigatorSidney Kimmel Cancer Center at Johns Hopkins

2 Previous Clinical Trials

234 Total Patients Enrolled

Media Library

Activated PTCy-MILs (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02342613 — Phase 1

Graft-versus-Host Disease Research Study Groups: MILs treatment

Graft-versus-Host Disease Clinical Trial 2023: Activated PTCy-MILs Highlights & Side Effects. Trial Name: NCT02342613 — Phase 1

Activated PTCy-MILs (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02342613 — Phase 1

Frequently Asked Questions

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

What is the upper limit of enrollees in this experiment?

"Affirmative. According to information hosted on clinicaltrials.gov, this medical research is actively looking for participants; it was first posted on May 28th 2015 and revised on May 10th 2022. A total of 27 individuals should be sought at one specific site."

Answered by AI

Has the FDA granted clearance to utilize Activated PTCy-MILs?

"The safety of Activated PTCy-MILs was assessed a 1 due to the limited efficacy and safety data available as this is only a Phase 1 trial."

Answered by AI

Is this experiment actively enrolling participants?

"According to information on clinicaltrials.gov, this investigation is presently seeking out participants. This project was initially published on May 28th 2015 and its most recent update occurred on the 10th of May 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Adoptive Immunotherapy With Activated Marrow Infiltrating Lymphocytes and Cyclophosphamide Graft-Versus-Host Disease Prophylaxis in Patients With Relapse of Hematologic Malignancies After Allogeneic Hematopoietic Cell Transplantation

2015. "Adoptive Immunotherapy With Activated Marrow Infiltrating Lymphocytes and Cyclophosphamide Graft-Versus-Host Disease Prophylaxis in Patients With Relapse of Hematologic Malignancies After Allogeneic Hematopoietic Cell Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02342613.