MedTrace Logo

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

NCT03751709 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-02-05

No results posted yet for this study

Summary

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.

Conditions

  • B-Cell Acute Lymphoblastic Leukaemia
  • ALL, Adult
  • B-ALL

Interventions

DRUG

Blinatumomab

Blinatumomab per package insert - via continuous infusion days 1-28 of Cycle 1 and Cycle 2, every 42 days.

OTHER

Haplo-Mismatched Cell Therapy (HMCT)

HMCT infusion Cycle 1, Day 15 and Cycle 2, Day 8 \& Day 15

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Cedars-Sinai Medical Center

    lead OTHER

Principal Investigators

  • Noah Merin, MD PhD · Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-14
Primary Completion
2023-03-27
Completion
2024-11-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03751709 on ClinicalTrials.gov