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NCT03751709 · ClinicalTrials.gov registry record · Phase 1
Blinatumomab Plus HLA-Mismatched Cellular Therapy for Relapsed/Refractory CD19+ ALL
A Phase 1 study, sponsored by Cedars-Sinai Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT03751709 is a Phase 1 study that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 22 participants.
The verdict
NCT03751709, a Phase 1 study, has completed, sponsored by Cedars-Sinai Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
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.
Interventions
- DRUG Blinatumomab
- OTHER Haplo-Mismatched Cell Therapy (HMCT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2020-02-14 |
| Est. Completion | 2024-11-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03751709
The ClinicalTrials.gov registry entry for NCT03751709 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Blinatumomab is the first listed.
NCT03751709 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03751709 about?
NCT03751709 is a clinical study titled "Blinatumomab Plus HLA-Mismatched Cellular Therapy for Relapsed/Refractory CD19+ ALL". 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 analogo...
What is the current status of trial NCT03751709?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2020-02-14. Estimated completion is 2024-11-12.
What interventions are being tested in trial NCT03751709?
The interventions under investigation include: Blinatumomab (DRUG), Haplo-Mismatched Cell Therapy (HMCT) (OTHER).
Who is sponsoring clinical trial NCT03751709?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
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