Trials Sponsors Conditions Drugs Pricing

Conditions

Cytopenia

Outcome Measures

Primary Outcomes (1)

Incidence of adverse events
The incidence of adverse events defined as dose-limiting toxicities (DLTs), cytokine release syndrome (CRS), and immune effector cell-associated neurotoxicity syndrome (ICANS).
within 28 days after the CAR-T administration

Secondary Outcomes (3)

Incidence of adverse events and serious adverse events following infusion
until 28 days after the CAR-T administration
Number of CAR-T cells in blood
Day +3, +7, +10, +14, +21, +28
Clinical response rate
At 3, 6, 9, and 12-months post infusion

Study Arms (2)

AZD0120 (cell therapy product) + Bendamustine

EXPERIMENTAL

Participants receive AZD0120 (CAR-T therapy product) on Day 0 and Bendamustine for 2 days prior to the CAR-T therapy administration.

Drug: AZD0120Drug: Bendamustin

AZD0120 (cell therapy product)

EXPERIMENTAL

Participants receive AZD0120 (CAR-T therapy product) on Day 0.

Drug: AZD0120

Interventions

AZD0120Drug

One time administration on Day 0.

AZD0120 (cell therapy product)AZD0120 (cell therapy product) + Bendamustine

BendamustinDrug

Participants will be given bendamustin for 2 days (study Day -5 and Day -4) followed by 3 days of rest.

AZD0120 (cell therapy product) + Bendamustine

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Diagnosis of primary chronic immune thrombocytopenia (ITP) or warm autoimmune hemolytic anemia (wAIHA) according to the published consensus criteria
a. 2 or more prior treatments for ITP wherein the following conditions are required to define prior treatments:

Sponsors & Collaborators

Saurabh Dahiya
Otherlead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

MeSH Terms

Conditions

Cytopenia

Interventions

Bendamustine Hydrochloride

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbons

Study Officials

Saurabh Dahiya, MD
Stanford University
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: OTHER
Intervention Model: SEQUENTIAL
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Associate Professor of Medicine

Study Record Dates

First Submitted

August 24, 2026

First Posted

August 27, 2026

Study Start

September 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

July 2041

You may not qualify if:

For ITP - ITP Bleeding Scale Grade 3 or higher at the screening visit (with the exception of menorrhagia controlled with hormonal therapy +/- tranexamic acid)
For wAIHA - subjects with signs of hemolysis not attributable to wAIHA are excluded.
For ITP - Secondary ITP (including but not limited to associated with a lymphoproliferative disorder, positive screening tests for HIV, HCV, H. pylori, Common Variable Immunodeficiency)
For wAIHA - Secondary wAIHA (including but not limited to associated with lymphoproliferative disorder, positive screening tests for HIV, HCV, Common Variable Immunodeficiency)
Prior treatment with any investigational agent within 3 months, or 5 half-lives, whichever is longer. Agents authorized by the FDA for prevention or treatment of SARS-CoV-2 are not considered investigational.
Subjects who received immunosuppressants (i.e., mycophenolate mofetil, azathioprine, methotrexate, calcineurin inhibitors, tyrosine kinase inhibitors) within one month prior to the CAR T infusion are excluded.
Presence of fungal, bacterial, viral, or other infection that is not controlled and/ or requiring hospitalization or treatment with IV antimicrobials within 4 weeks of screening. Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment.
Psychiatric disorder(s) or psychosocial circumstance(s) which in the opinion of the Stanford Transplant team caring for this potential patient would place the patient at an unacceptable risk. Participant has significant neurological or psychiatric condition (active or history of) including but not limited to severe brain injury, dementia, cerebellar disease, Parkinson's disease, clinical evidence of dementia or altered mental status, or stroke, intracranial hemorrhage, or seizure within 6 months before signing ICF. Participants with existing stable, mild neurological conditions that have not progressed in the last 6 months (e.g., essential tremor) may be considered eligible at the Investigator's discretion, following appropriate neurological consultation.
Presence or history of liver cirrhosis.
Presence or history of MDS; presence of bone marrow failure and malignant bone marrow disorders confirmed by bone marrow examination (aspirate and/or biopsy).
Patients without a bone marrow aspirate and/or biopsy performed within 12 months prior to screening to confirm the primary cause of the disease.
History of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g., cervix, bladder, breast) or localized prostate cancer requiring no treatment unless disease free for at least 2 years.
Active infection with HIV, hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive) as the immunosuppression contained in this study may pose unacceptable risk. A prior history of hepatitis B or hepatitis C is permitted providing the viral load is undetectable per quantitative PCR and/or nucleic acid testing. Hepatitis B surface antibody following hepatitis B immunization is not considered to be evidence of past infection.
History of Crohn's, rheumatoid arthritis, systemic lupus that required continued systemic immunosuppression/systemic disease modifying agents within the 2 years prior to trial enrollment.
A primary immune deficiency disease.
+7 more criteria

Autoimmune Cytopenia Elimination by Chimeric Antigen Receptor T-cell Therapy

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

AZD0120 (cell therapy product) + Bendamustine

AZD0120 (cell therapy product)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

AZD0120 (cell therapy product) + Bendamustine

AZD0120 (cell therapy product)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations