UTAA09 Injection in the Treatment of Relapsed/Refractory Hematolymphatic Malignancies.
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age3-70
SponsorPersonGen BioTherapeutics (Suzhou) Co., Ltd.
About this trial
This study is designed for exploring the preliminary safety and efficacy of the recombinant allogeneic healthy γδT cells transduced with the anti-CD19 lentiviral vector in patients with CD19-positive B cell hematolymphatic malignancies.
Eligibility criteria
Qualifiers
Patients aged between 3~70 (including cut-off values), regardless of gender and race;
Expected survival time>12 weeks;
ECOG score 0-2;
CD19-positive relapsed/refractory B-cell hematolymphatic malignancies;
Disqualifiers
Those with graft-versus-host disease (GVHD) or requiring long-term systemic immunosuppressants;
Malignant tumors other than CD19-positive hematologic malignancies within 5 years prior to screening, except adequately treated cervical carcinoma in situ, basal cell or squamous epithelial cell skin cancer, local prostate cancer after radical resection, and breast ductal carcinoma in situ after radical resection;
Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood hepatitis B virus (HBV) DNA titer outside the normal reference range; Those who are positive for hepatitis C virus (HCV) antibodies and positive for hepatitis C virus (HCV) RNA in peripheral blood; Human immunodeficiency virus (HIV) antibody positive person; Positive for cytomegalovirus (CMV) DNA testing; those who test positive for syphilis;
Serious heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months before screening), congestive heart failure (NYHA classification ≥ III), and serious arrhythmia;
Trial design
Treatments tested in this trial
- UTAA09 cells for infusion
- Fludarabine
- Cyclophosphamide
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Lead sponsor
Anhui Provincial Hospital
Collaborator
Source ClinicalTrials.gov