Blinatumomab + HMCT for Acute Lymphoblastic Leukemia

Overseen By Karla Russell

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Cedars-Sinai Medical Center

Must not be taking: Immunosuppressants, Mycophenolate, Cyclosporine, others

Disqualifiers: Pregnancy, CNS disease, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

22 Participants Needed

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

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Cycle 1

Participants receive blinatumomab and one infusion of HMCT starting on day 15 after initial CRS resolution

4 weeks

Weekly visits for monitoring

Treatment Cycle 2

Participants receive blinatumomab and two infusions of HMCT with dose escalation based on T cell content

4 weeks

Weekly visits for monitoring

Follow-up

Participants are monitored for safety, side effects, and effectiveness of the treatment

up to 6 months

Treatment Details

Interventions

• Blinatumomab
• Haplo-Mismatched Cell Therapy (HMCT)

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)

Blinatumomab is already approved in European Union, United States for the following indications:

Approved in European Union as Blincyto for:

• Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (BCP-ALL)
• High-risk first relapse BCP-ALL

Approved in United States as Blincyto for:

• Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (BCP-ALL)
• First or second complete remission with minimal residual disease (MRD)

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

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