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

ConditionCD19-positive Relapsed or Refractory B-cell Malignancies
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age3-70
SponsorPersonGen BioTherapeutics (Suzhou) Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • UTAA09 cells for infusion

    Biological/Vaccine

    Intravenous injection, dosage:1-10×10\^8 CAR+ γδT cells, Cell concentration: 2×10\^7 cells/mL.

  • Fludarabine

    Drug

    30 mg/m\^2/day×4 days

  • Cyclophosphamide

    Drug

    1000 mg/m\^2/day×3 days

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: UTAA09 cells for infusionExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Assessment of the safety after UTAA09 injection treatment

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.

Time frame
About 2 years
2

Evaluation of the efficacy after UTAA09 injection treatment

3-month total response rate (ORR) which includes CR, CRi, and PR will be assessed.

Time frame
About 3 months

Secondary outcomes

1

Assessment of pharmacokinetic (about Cmax)

Assessment of the peak Plasma Concentration (Cmax) of UTAA09 cells amplified in peripheral blood after administration.

Time frame
About 2 years
2

Assessment of pharmacokinetic (about Tmax)

Assessment of the time to reach the highest concentration (Tmax) of UTAA09 cells amplified in peripheral blood after administration.

Time frame
About 2 years
3

Assessment of pharmacokinetic (about AUC0-28d)

Assessment of the Area under the plasma concentration versus time curve (AUC) for 28 days after UTAA09 cells administration.

Time frame
About 2 years
4

Assessment of pharmacokinetic (about AUC0-90d)

Assessment of the Area under the plasma concentration versus time curve (AUC) for 90 days after UTAA09 cells administration.

Time frame
About 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Lead sponsor

Anhui Provincial Hospital

Collaborator

Source ClinicalTrials.gov
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