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Trial Title:
UTAA09 Injection in the Treatment of Relapsed/Refractory Hematolymphatic Malignancies.
NCT ID:
NCT06092047
Condition:
CD19-positive Relapsed or Refractory B-cell Malignancies
Conditions: Official terms:
Neoplasms
Cyclophosphamide
Fludarabine
Conditions: Keywords:
CD19 target
UCAR-T
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
UTAA09 injection
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
UTAA09 cells for infusion
Description:
Intravenous injection, dosage:1-10×10^8 CAR+ γδT cells, Cell concentration: 2×10^7
cells/mL.
Arm group label:
UTAA09 cells for infusion
Intervention type:
Drug
Intervention name:
Fludarabine
Description:
30 mg/m^2/day×4 days
Arm group label:
UTAA09 cells for infusion
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
1000 mg/m^2/day×3 days
Arm group label:
UTAA09 cells for infusion
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.
Criteria for 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.
Gender:
All
Minimum age:
3 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of USTC (AnHui Provincial Hospital)
Address:
City:
Hefei
Zip:
230000
Country:
China
Contact:
Last name:
xingbing wang, MD
Phone:
+86 18963789012
Email:
wangxingbing@ustc.edu.cn
Start date:
October 2023
Completion date:
April 2028
Lead sponsor:
Agency:
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Agency class:
Industry
Collaborator:
Agency:
Anhui Provincial Hospital
Agency class:
Other
Source:
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06092047
