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NCT Number: NCT06503211

On the Safety, Tolerability, and Efficacy of UTAA09 Injection in the Treatment of Lymphoma

The main research objective is to evaluate the safety, tolerability, and pharmacokinetic characteristics of UTAA09 cell preparation in the treatment of relapsed/refractory B-cell non Hodgkin's lymphoma patients. The secondary research objective is to explore the clinical efficacy of UTAA09 injection after administration and to explore the content of CD19 positive B cells in peripheral blood after UTAA09 injection administration.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PersonGen.Anke Cellular Therapeutice Co., Ltd.

Hefei, Anhui, 230088, China

Location status: Recruiting

Location contact

Huimin Meng, Doctor

CONTACT

[email protected]

+86-18015580390

About this study

Single dose, single arm trial, exploring the initial 28 day safety and efficacy of the investigational drug.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects voluntarily participate in clinical studies;
  • ECOG score 0-1 points;
  • Histologically confirmed large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, and inert lymphoma transformed into diffuse large B-cell lymphoma; CD19 and/or CD20 positivity;
  • At least one measurable tumor lesion determined according to Lugano's criteria: the longest diameter of intranodal lesions>1.5cm, and the longest diameter of extranodal lesions>1.0cm.

Exclusion criteria

  • Received other chimeric antigen receptor therapy or gene modified cell therapy before screening;
  • Subjects who were undergoing systemic steroid therapy during screening and were determined by the researchers to require long-term use of systemic steroid therapy during the treatment period (excluding inhalation or local use);
  • Any unstable heart disease, including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association [NYHA] classification ≥ III), and severe arrhythmia.

Treatment and study plan

UTAA09 injection

Biological

The subjects, who sign the informed consent forms and been screeneinclusion/exclusion criteria, will be assigned into 3 x 108~1 x 1010 CD19-CAR - γδT cells.

Primary outcomes

  1. The incidence of dose limiting toxicity (DLT )

    Time frame: 28 days after infusion

    The incidence, severity, and types of dose limiting toxicity

  2. The incidence of TEAEs

    Time frame: 28 days after infusion

    The incidence, severity, and types of adverse events that occur during treatment

Secondary outcomes

  1. ORR

    Time frame: 24 months after infusion

    Evaluate the overall response rate based on the efficacy criteria of Lugano 2014

  2. PFS

    Time frame: 24 months after infusion

    Evaluate the progression free survival based on the efficacy criteria of Lugano 2014

  3. OS

    Time frame: 24 months after infusion

    Evaluate the overall survival based on the efficacy criteria of Lugano 2014

Study contacts

Contact information is provided by the study sponsor or research team.

Lei Fan, Doctor

CONTACT

[email protected]

86-13813976136

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

Phase I Clinical Study on the Safety, Tolerability, and Efficacy of UTAA09 Injection in the Treatment of Recurrent or Refractory B-cell Non Hodgkin's Lymphoma

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 16, 2024
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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