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BiTE Antibody

Blinatumomab + HMCT for Acute Lymphoblastic Leukemia

Phase 1

Waitlist Available

Led By Noah Merin, MD PhD

Research Sponsored by Cedars-Sinai Medical Center

Eligibility Criteria Checklist

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

Must have

Adequate organ function including serum creatinine ≤ 2.0 x ULN, total bilirubin ≤ 1.5x ULN, AST/ALT ≤ 2.5 x ULN (≤ 5 x ULN for suspected liver involvement of leukemia), ECOG performance status of 0, 1, or 2, and estimated survival of at least 3 months

Patient has at least one medically fit first- or second-degree family member who is a potential haploidentical donor willing to donate peripheral blood cells and sign consent forms

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

Study Summary

This trial is a study to test if a new combination treatment of blinatumomab and Haplo-Mismatched Cellular Therapy is safe and effective. The trial will enroll ten subjects and will administer the HMCT either once or twice during the first and second cycles of blinatumomab treatment. The CD3+ cell dose of the HMCT infusion is governed by dose escalation / de-escalation following a Bayesian method.

Who is the study for?

Adults with relapsed/refractory CD19+ Acute Lymphoblastic Leukemia, including those who've had prior blinatumomab treatment without severe side effects. Participants need a haploidentical family member donor for cell therapy, good organ function, and no recent major surgery or active CNS disease. They must not be pregnant and agree to use contraception.Check my eligibility

What is being tested?

The trial tests combining standard blinatumomab with Haplo-Mismatched Cellular Therapy (HMCT) from a half-matched family donor in adults with specific leukemia. It's a Phase 1 study where patients receive HMCT infusions during two cycles of blinatumomab treatment, adjusting doses based on safety data.See study design

What are the potential side effects?

Potential side effects include reactions related to immune system activation such as fever and fatigue, infusion-related reactions from the cellular therapy, and possible complications from mobilizing immune cells against cancerous cells.

Eligibility Criteria

Inclusion Criteria

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

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I have a family member ready and medically fit to donate blood cells for my treatment.

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I am 18 years old or older.

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My cancer is high-risk, having relapsed multiple times or not responded to initial treatments.

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My leukemia has returned or didn't respond to treatment, and tests show a small amount of cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Incidence of DLTs

Secondary outcome measures

Disease burden measured as the minimal residual disease (MRD) response from time of transplant to one day following the second treatment

Number of participants experiencing complete response (CR) from time of transplant to one day following the second treatment

Number of participants experiencing complete response with incomplete count recovery (CRi) from time of transplant to one day following the second treatment

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: SubjectsExperimental Treatment2 Interventions

Blinatumomab+Haplo-Mismatched Cell Therapy (HMCT)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Blinatumomab

2014

Completed Phase 3

~1210

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor

498 Previous Clinical Trials

164,827 Total Patients Enrolled

AmgenIndustry Sponsor

1,369 Previous Clinical Trials

1,377,536 Total Patients Enrolled

Noah Merin, MD PhDPrincipal Investigator - Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute

Cedars-Sinai Medical Center, Sound Physicians Platinum Group Pc

1 Previous Clinical Trials

6 Total Patients Enrolled

Media Library

Blinatumomab (BiTE Antibody) Clinical Trial Eligibility Overview. Trial Name: NCT03751709 — Phase 1

Acute Lymphoblastic Leukemia Research Study Groups: Subjects

Acute Lymphoblastic Leukemia Clinical Trial 2023: Blinatumomab Highlights & Side Effects. Trial Name: NCT03751709 — Phase 1

Blinatumomab (BiTE Antibody) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03751709 — Phase 1

Frequently Asked Questions

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

Are there any participant openings for this clinical research endeavor?

"Affirmative. According to the clinicaltrials.gov, this medical trial commenced on February 14th 2020 and is currently recruiting patients for its second phase. It requires 10 participants from a single site."

Answered by AI

How efficacious is Haplo-Mismatched Cell Therapy (HMCT) for the general population?

"The safety of Haplo-Mismatched Cell Therapy (HMCT) has been appraised by our team at Power as a 1, given that this is an initial Phase 1 trial with only preliminary data on its efficacy and safety."

Answered by AI

Have any other studies previously explored the viability of Haplo-Mismatched Cell Therapy (HMCT)?

"Presently, 46 clinical trials related to Haplo-Mismatched Cell Therapy (HMCT) are underway with 9 of them having reached Phase 3. While most of these studies have been launched from Santa Barbara, California, there is research being conducted at 2,395 other locations."

Answered by AI

What is the total number of participants enrolled in this investigation?

"Indeed, the information on clinicaltrials.gov indicates that this trial is presently enrolling participants. It was first posted in February of 2020 and last updated in May 2022; it seeks 10 patients from 1 site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Blinatumomab Plus HLA-Mismatched Cellular Therapy for Relapsed/Refractory CD19+ ALL

Noah Merin 2020. "Blinatumomab Plus HLA-Mismatched Cellular Therapy for Relapsed/Refractory CD19+ ALL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03751709.