A Phase 1, Open-Label, Single Center Study of AZD0120 (Also Known as GC012F), a Chimeric Antigen Receptor T Cell Therapy Targeting CD19 and B Cell Maturation Antigen (BCMA), in Subjects With Relapsed and Refractory Persistent Autoimmune Cytopenia

Saurabh Dahiya

Summary

This is a phase 1 study to evaluate the safety and tolerability of AZD0120 in patients with relapsed or refractory immune mediated cytopenia (primary chronic Immune Thrombocytopenia (ITP) or autoimmune hemolytic anemia (wAIHA)).

Eligibility

Age range: 18–80 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: 1. Diagnosis of primary chronic immune thrombocytopenia (ITP) or warm autoimmune hemolytic anemia (wAIHA) according to the published consensus criteria 2. a. 2 or more prior treatments for ITP wherein the following conditions are required to define prior treatments: * 1st line treatment includes steroids (dexamethasone, prednisone or equivalent), IVIG, and/or Anti-Rhd Ig. These medications may be administered in combination or in series. * 2nd line treatment includes the use of thrombopoietic agents, and anti-CD20 mAbs. These medications may be given in combinat…

Interventions

Drug
AZD0120
One time administration on Day 0.
Drug
Bendamustin
Participants will be given bendamustin for 2 days (study Day -5 and Day -4) followed by 3 days of rest.

Location

Stanford University
Stanford, California

A Phase 1, Open-Label, Single Center Study of AZD0120 (Also Known as GC012F), a Chimeric Antigen Receptor T Cell Therapy Targeting CD19 and B Cell Maturation Antigen (BCMA), in Subjects With Relapsed and Refractory Persistent Autoimmune Cytopenia

Summary

Eligibility

Interventions

Location

Compensation

Run this study?

Details

Conditions