A-CAR028 for relapsed or refractory acute myeloid leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, open-label Phase 1 study testing A-CAR028 in adults with relapsed or refractory acute myeloid leukemia. Eligible participants undergo screening, leukapheresis for collection of their T cells, manufacturing of the A-CAR028 product, baseline testing, lymphodepleting chemotherapy, and a single A-CAR028 infusion followed by dose-limiting toxicity observation and scheduled follow-up visits. The primary focus is on safety and tolerability, with secondary measures of anti-leukemia activity and durability of response. The study is conducted at the First Affiliated Hospital, School of Medicine, Zhejiang University, with collaboration from Shanghai AbelZeta Ltd.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 18 to 75 years old at the time of signing the Informed Consent Form (ICF)
* More than 12 weeks of expected survival
* ECOG score 0 or 1
* Relapsed or refractory AML
* Adequate organ function

Exclusion Criteria:

* Acute Promyelocytic Leukemia (APL)
* Mixed Phenotype Acute Leukemia (MPAL)
* Acute Undifferentiated Leukemia (AUL)
* Only extramedullary leukemia
* Known allergies to the components or excipients of the A-CAR028 cell product
* Severe heart diseases, including but not limited to, myocardial infarction, angioplasty or stent implantation within 12 months prior to signing the ICF, unstable angina pectoris, severe arrhythmia, history of severe non-ischemic cardiomyopathy, heart failure
* Autologous or allogeneic hematopoietic stem cell transplantation within 3 months prior to signing the ICF
* Central nervous system (CNS) involvement or symptoms of CNS involvement (including cranial nerve lesions and extensive lesions or spinal cord compression)
* A stroke or seizure occurred within 12 months prior to signing the ICF
* Malignancy history within 5 years prior to signing the ICF
* Uncontrolled active infection
* Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Treponema Pallidum (TP) positive, Cytomegalovirus (CMV) DNA positive
* Live vaccine injection within 4 weeks prior to signing the ICF
* Acute or chronic graft-versus-host disease (GVHD) was present at screening
* Inadequate washing time for previous treatment
* Previously treated with CAR-T cell products or genetically modified T cell therapies

Where it's running

• Department of Hematology, The First Affiliated Hospital, School of Medicine, Zhejiang University
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Jie Jin, MD
• Email: jiej0503@163.com
• Phone: +86-0571-87236898

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CAR-T Therapy Safety, Response, and Immune-Escape: Observational Study in Adults

  This observational study looks at adults who receive CAR-T cell therapy or bispecific antibodies to see which factors predict response and immune-related side effects.

  Recruiting IRCCS San Raffaele · Milan, Italy · NCT07915102

• PBSS1113 with azacitidine for AML and higher-risk MDS

  This study tests PBSS1113 together with azacitidine to see if it is safe and may help people with AML or higher-risk MDS who are newly diagnosed and not fit for intense chemotherapy or who have relapsed/refractory disease.

  Recruiting Phase 1/2 Chaser Therapeutics, Inc. · Hangzhou, Zhejiang · NCT07761533

• Caris Chromoseq data collection for AML, MDS, and MPN

  This study tests how well the Caris Chromoseq assay helps categorize risk in patients with AML, MDS, or MPN compared with standard tests.

  Recruiting Caris Science, Inc. · Phoenix, Arizona · NCT07680868

• Venetoclax TDM in newly diagnosed AML: exposure and prognosis

  This study checks if measuring venetoclax levels and adjusting treatment helps people with newly diagnosed AML who are getting VEN-AZA.

  Recruiting The First Affiliated Hospital of Soochow University · Suzhou · NCT07670130

• CAR-T cells targeting CD33 and CLL1 for relapsed or refractory AML

  A one-arm early-stage trial tests whether a patient’s own engineered CAR-T cells (ICG415) can be safely given after conditioning chemotherapy to see if they can help adults with relapsed or refractory AML.

  Recruiting at 2 sites Phase 1 iCell Gene Therapeutics · Nanchang, Jiangxi and 1 other locations · NCT07668557

• Ziftomenib for relapsed/refractory NPM1-mutated AML in Japanese adults

  This study will test whether ziftomenib can help adults with relapsed or refractory NPM1-mutated AML who have few other options.

  Recruiting at 15 sites Phase 2 Kyowa Kirin Co., Ltd. · Chiba and 19 other locations · NCT07623616

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.