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Recruiting NCT06092047

UTAA09 Injection in the Treatment of Relapsed/Refractory Hematolymphatic Malignancies.

Early Phase I Interventional CD19-positive Relapsed or Refractory B-cell Malignancies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: UTAA09 cells for infusion, Fludarabine, Cyclophosphamide.
Who it may be relevant to
Registry conditions: CD19-positive Relapsed or Refractory B-cell Malignancies. Basic parameters: 3 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Clinical Study of Universal Off-the-shelf Cell Products in Patients With CD19-positive Relapsed/Refractory B-cell Hematolymphatic Malignancies.

Overview

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.

Interventions

  • Biological UTAA09 cells for infusion
    Intravenous injection, dosage:1-10×10\^8 CAR+ γδT cells, Cell concentration: 2×10\^7 cells/mL.
  • Drug Fludarabine
    30 mg/m\^2/day×4 days
  • Drug Cyclophosphamide
    1000 mg/m\^2/day×3 days

Primary outcome measures

  • Assessment of the safety after UTAA09 injection treatment [Time frame: About 2 years]
  • Evaluation of the efficacy after UTAA09 injection treatment [Time frame: About 3 months]
Secondary outcome measures (8)
  • Assessment of pharmacokinetic (about Cmax) [Time frame: About 2 years]
  • Assessment of pharmacokinetic (about Tmax) [Time frame: About 2 years]
  • Assessment of pharmacokinetic (about AUC0-28d) [Time frame: About 2 years]
  • Assessment of pharmacokinetic (about AUC0-90d) [Time frame: About 2 years]
  • Evaluation of Pharmacodynamic [Time frame: About 2 years]
  • To evaluate the efficacy (Overall Survival) [Time frame: About 2 years]
  • To evaluate the efficacy (Duration Of Response) [Time frame: About 2 years]
  • To evaluate the efficacy (Progression Free Survival) [Time frame: About 2 years]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital of USTC (AnHui Provincial Hospital) — Hefei

Identifiers

NCT: NCT06092047 · PG-CART-UTAA09-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗