Clinical trial NCT06092047: UTAA09 Injection in the Treatment of Relapsed/Refractory Hematolymphatic Malignancies.
Official title: Clinical Study of Universal Off-the-shelf Cell Products in Patients With CD19-positive Relapsed/Refractory B-cell Hematolymphatic Malignancies.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: CD19-positive Relapsed or Refractory B-cell Malignancies
Keywords: CD19 target
UCAR-T
Lead sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Anhui Provincial Hospital
First posted: 2023-10-23
Enrollment: 10
Sex: ALL
Minimum age (years): 3
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: UTAA09 injection
Primary purpose: TREATMENT

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.

Detailed description: A single arm open-label clinical study is designed to prelinarily determine the safety, efficacy, the ratio of CD19-positive cells in peripheral blood and cell kinetics after administration of UTAA09 injection in patients with CD19-positive relapsed/refractory B-cell hematolymphatic malignancies. All subjects will receive UTAA09 cells infusion.

Primary objective: explore the preliminary safety and efficacy of UTAA09 injection in patients with CD19-positive relapsed/refractory B-cell line hematolymphatic malignancies.

Secondary objectives:

1. explore the distribution, amplification and survival of UTAA09 cells in vivo after administration of UTAA09 injection;
2. explore the ratio of CD19-positive cells in peripheral blood after administration of UTAA09 injection.

Eligibility criteria: Inclusion Criteria:

1. Patients aged between 3\~70 (including cut-off values), regardless of gender and race;
2. Expected survival time\>12 weeks;
3. ECOG score 0-2;
4. CD19-positive relapsed/refractory B-cell hematolymphatic malignancies;
5. Liver and kidney function, cardiopulmonary function meet the following requirements:

   1. Creatinine ≤ 1.5 ULN;
   2. Left ventricular ejection fraction ≥ 45%;
   3. blood oxygen saturation\>91%;
   4. Total bilirubin ≤ 1.5 × ULN； ALT and AST ≤ 2.5 × ULN;
6. Be able to understand the trial and have signed the informed consent.

Exclusion Criteria:

1. Those with graft-versus-host disease (GVHD) or requiring long-term systemic immunosuppressants;
2. 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;
3. 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;
4. 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;
5. Unstable systemic diseases judged by the investigator: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment;
6. 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);
7. 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;
8. 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;
9. Participated in other clinical studies within 3 month before screening;
10. There was evidence of central nervous system involvement at participant screening;
11. Conditions that the investigators considered unsuitable for enrollment.

Primary outcomes:
measure: Assessment of the safety after UTAA09 injection treatment
timeFrame: About 2 years
measure: Evaluation of the efficacy after UTAA09 injection treatment
timeFrame: About 3 months
Secondary outcomes:
measure: Assessment of pharmacokinetic (about Cmax)
timeFrame: About 2 years
measure: Assessment of pharmacokinetic (about Tmax)
timeFrame: About 2 years
measure: Assessment of pharmacokinetic (about AUC0-28d)
timeFrame: About 2 years
measure: Assessment of pharmacokinetic (about AUC0-90d)
timeFrame: About 2 years
measure: Evaluation of Pharmacodynamic
timeFrame: About 2 years
measure: To evaluate the efficacy (Overall Survival)
timeFrame: About 2 years
measure: To evaluate the efficacy (Duration Of Response)
timeFrame: About 2 years
measure: To evaluate the efficacy (Progression Free Survival)
timeFrame: About 2 years
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of USTC (AnHui Provincial Hospital)
state: Anhui
Study officials:
affiliation: The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
name: Xingbing Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: