Clinical Trials Logo
  1. Home
  2. B-ALL
  3. NCT03751709

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

B-ALL Clinical Trial

Official title:
IIT2017-05-MERIN-BLINHMCT: Blinatumomab Plus HLA-Mismatched Cellular Therapy (HMCT) for Relapsed/Refractory CD19+ ALL

Clinical Trial 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.

Clinical Trial Description

This single center, phase 1 study will examine the safety, side effects, and effectiveness of combining the investigational use of Haplo-Mismatched Cellular Therapy (HMCT) in combination with blinatumomab. Investigators plan to give HMCT starting on day 15, after the initial CRS caused by blinatumomab has resolved. The investigational treatment will start with 1% of the typical HMCT dose (10e6 CD3+ cells/kg) and will employ a modified dose escalation design as an additional safety measure. The primary end points will be DLT of the combination of blinatumomab and HMCT. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03751709
Study type Interventional
Source Cedars-Sinai Medical Center
Contact
Status Active, not recruiting
Phase Phase 1
Start date February 14, 2020
Completion date March 2025
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04088890 - Autologous CD22 CAR T Cells in Adults w/ Recurrent or Refractory B Cell Malignancies Phase 1
Recruiting NCT04546906 - Safety and Efficacy Study of CD22 CAR-T Cells for Relapsed or Refractory Acute Lymphoblastic Leukemia N/A
Recruiting NCT04546893 - Safety and Efficacy Study of SL1904B CAR-T Cells for Relapsed or Refractory B-Cell Acute Lymphocyte Leukemia N/A
Active, not recruiting NCT01209286 - Study of the BiTE® Blinatumomab (MT103) in Adult Patients With Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL) Phase 2
Withdrawn NCT05571540 - Anti-CD19 Universal CAR-T Cells for r/r CD19+ B-ALL Phase 1/Phase 2
Completed NCT01290120 - Chemotherapy Plus Rituximab Combination for Adult Lymphoblastic Leukemia (B-ALL) and Burkitt's Non-Hodgkin Lymphoma Phase 2
Recruiting NCT04781634 - a Clinical Research of CD19 and CD22 Targeted Prime CAR-T Cell in Relapsed/Refractory B-ALL Phase 1/Phase 2
Recruiting NCT03448393 - CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies Phase 1
Recruiting NCT05350787 - Evaluate the Safety, Efficacy and Pharmacokinetics of ThisCART19A in Patients With R/R B-ALL Phase 1
Recruiting NCT05350852 - Evaluate the Safety, Efficacy and Pharmacokinetics of ThisCART19A in Patients With MRD+ B-ALL Phase 1
Recruiting NCT05621291 - A Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymphoblastic Leu... N/A
Active, not recruiting NCT04318678 - CD123-Directed Autologous T-Cell Therapy for Acute Myelogenous Leukemia (CATCHAML) Phase 1
Active, not recruiting NCT04499573 - Bispecific CD19/CD22 CAR-T for Treatment of Children and Young Adults With r/r B-ALL Phase 1/Phase 2
Recruiting NCT04512716 - Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma Early Phase 1
Recruiting NCT05639179 - Novel Anti-CD19 Universal CAR-T Cells for r/r CD19+ B-ALL Phase 1/Phase 2
Recruiting NCT04792593 - Senl-h19 CAR-T Cell Injection in the Treatment of Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia N/A
Recruiting NCT05442515 - CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies Phase 1/Phase 2
Active, not recruiting NCT02328014 - Acalabrutinib (ACP-196) in Combination With ACP-319, for Treatment of B-Cell Malignancies Phase 1/Phase 2
Active, not recruiting NCT02315612 - Anti-CD22 Chimeric Receptor T Cells in Pediatric and Young Adults With Recurrent or Refractory CD22-expressing B Cell Malignancies Phase 1