UTAA09 injection for treating relapsed or refractory B-cell cancers

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

This study is testing a new cell treatment called UTAA09 to see if it can help people with certain types of B-cell cancers that have come back or didn't respond to other treatments.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 3 Years to 70 Years
• Sex: All
• Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd. (industry)
• Locations: 1 site (Hefei, Anhui)
• Trial ID: NCT06092047 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and efficacy of UTAA09, a recombinant allogeneic healthy γδT cell infusion, in patients with CD19-positive relapsed or refractory B-cell hematolymphatic malignancies. The study is a single-arm, open-label design where all participants will receive the UTAA09 cell infusion along with Fludarabine and Cyclophosphamide. The primary objective is to assess the preliminary safety and efficacy of the treatment, while secondary objectives include monitoring the distribution and survival of the infused cells and the ratio of CD19-positive cells in the blood post-treatment.

Who should consider this trial

Good fit: Ideal candidates are patients aged 3 to 70 with CD19-positive relapsed or refractory B-cell hematolymphatic malignancies.

Not a fit: Patients with graft-versus-host disease or those requiring long-term systemic immunosuppressants may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat B-cell malignancies.

How similar studies have performed: Other studies using similar approaches with CAR-T cell therapies have shown promising results, indicating potential for success in this novel application.

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.

Where this trial is running

Hefei, Anhui

• The First Affiliated Hospital of USTC (AnHui Provincial Hospital) — Hefei, Anhui, China (RECRUITING)

Study contacts

• Principal investigator: Xingbing Wang, MD — The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
• Study coordinator: Xingbing Wang, MD

Conditions: CD19-positive Relapsed or Refractory B-cell Malignancies, CD19 target, UCAR-T