UTAA09 Injection in the Treatment of Relapsed/Refractory Hematolymphatic Malignancies.
Clinical Study of Universal Off-the-shelf Cell Products in Patients With CD19-positive Relapsed/Refractory B-cell Hematolymphatic Malignancies.
1 other identifier
interventional
10
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1
Started Oct 2023
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2023
CompletedFirst Submitted
Initial submission to the registry
October 7, 2023
CompletedFirst Posted
Study publicly available on registry
October 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
May 16, 2025
May 1, 2024
2.8 years
October 7, 2023
May 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Assessment of the safety after UTAA09 injection treatment
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
About 2 years
Evaluation of the efficacy after UTAA09 injection treatment
3-month total response rate (ORR) which includes CR, CRi, and PR will be assessed.
About 3 months
Secondary Outcomes (8)
Assessment of pharmacokinetic (about Cmax)
About 2 years
Assessment of pharmacokinetic (about Tmax)
About 2 years
Assessment of pharmacokinetic (about AUC0-28d)
About 2 years
Assessment of pharmacokinetic (about AUC0-90d)
About 2 years
Evaluation of Pharmacodynamic
About 2 years
- +3 more secondary outcomes
Study Arms (1)
UTAA09 cells for infusion
EXPERIMENTALOff-the-shelf γδT cells with a CD19-redirected Chimeric Antigen Receptor. Route of administration: Intravenous injection. Lymphodepleting conditioning regimen: A combination of fludarabine and cyclophosphamide will be administered at Day-7\~Day-2.
Interventions
Intravenous injection, dosage:1-10×10\^8 CAR+ γδT cells, Cell concentration: 2×10\^7 cells/mL.
Eligibility Criteria
You may qualify if:
- 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;
- Liver and kidney function, cardiopulmonary function meet the following requirements:
- Creatinine ≤ 1.5 ULN;
- Left ventricular ejection fraction ≥ 45%;
- blood oxygen saturation\>91%;
- Total bilirubin ≤ 1.5 × ULN； ALT and AST ≤ 2.5 × ULN;
- Be able to understand the trial and have signed the informed consent.
You may not qualify if:
- 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;
- Unstable systemic diseases judged by the investigator: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment;
- Within 7 days before screening, there is active infection or uncontrollable infection requiring systemic treatment (except for mild genitourinary system infection and upper respiratory tract infection);
- Pregnant or lactating women, female subjects who planned to conceive within 1 year of cell infusion or male subjects whose partner planned pregnancy within 1 year of their cell infusion;
- Screening participants (except for inhalation or local use) who were receiving systemic steroid treatment within 7 days before screening or who were judged by the investigator to require long-term systemic steroid therapy during treatment;
- Participated in other clinical studies within 3 month before screening;
- There was evidence of central nervous system involvement at participant screening;
- Conditions that the investigators considered unsuitable for enrollment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of USTC (AnHui Provincial Hospital)
Hefei, Anhui, 230000, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xingbing Wang, MD
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2023
First Posted
October 23, 2023
Study Start
October 1, 2023
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
April 1, 2028
Last Updated
May 16, 2025
Record last verified: 2024-05