Blinatumomab + HMCT for Acute Lymphoblastic Leukemia

Overseen by Noah Merin, MD PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Cedars-Sinai Medical Center

No Placebo Group

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

Single center Phase 1 dose escalation trial of the combination of standard-of-care blinatumomab plus Haplo-Mismatched Cellular Therapy (HMCT). HMCT refers to the infusion of donor peripheral blood mononuclear cells collected via pheresis from a haploidentical family member - the procedure is analogous to giving a donor lymphocyte infusion outside of the setting of an allogeneic stem cell transplant; also known as 'microtransplantation'. The HMCT is an unselected mix of lymphocytes and leukocytes, but the product dose escalation will be done based on the T cell content. Ten recipients are planned. Each subject will be administered one infusion of HMCT during the first cycle of blinatumomab and two infusions during cycle two of blinatumomab; the CD3+ cell dose of the HMCT infusion is governed by dose escalation / de-escalation following a Bayesian method.

Research Team

Noah Merin, MD PhD

Principal Investigator

Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute

Eligibility Criteria

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.

Inclusion Criteria

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

Written informed consent obtained from subject and ability to comply with study requirements

I am 18 years old or older.

Exclusion Criteria

I have had a stem cell transplant from a donor.

I have hepatitis B or C but am on treatment.

Likely unavailability to complete all protocol-required study visits or procedures

Treatment Details

Interventions

• Blinatumomab (BiTE Antibody)
• Haplo-Mismatched Cell Therapy (HMCT) (Cell Therapy)

Trial Overview 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.

Participant Groups

Group I: Subjects Experimental Treatment 2 Interventions

Blinatumomab+Haplo-Mismatched Cell Therapy (HMCT)

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

David E. Cohen

Cedars-Sinai Medical Center

Chief Medical Officer

MD and PhD in Physiology and Biophysics from Harvard University

Peter L. Slavin

Cedars-Sinai Medical Center

Chief Executive Officer

MD from Harvard Medical School, MBA from Harvard Business School

Amgen

Industry Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London