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A Study of CTA101 UCAR-T Cell Injection in Patients With Relapsed or Refractory CD19+ B-line Hematological Malignancy

ConditionsAcute Lymphoblastic LeukemiaNon-hodgkin Lymphoma
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age3-70
SponsorHe Huang

About this trial

A study of CTA101 UCAR-T cell injection in patients with relapsed or refractory CD19+ B-line hematological malignancy

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female aged ≥ 3 and <70 years old;

Histologically confirmed diagnosis of CD19+ B-ALL per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2016.v1);

CR not achieved after standardized chemotherapy;

CR achieved following the first induction, but CR duration is ≤ 12 months;

Disqualifiers

patients with extramedullary lesions, except those with CNSL (CNS-1) under effective control (for ALL patients only);

Confirmed diagnosis of lymphoblastic crisis of chronic myeloid leukemia, Burkitt's leukemia/lymphoma per WHO Classification Criteria (for ALL patients only);

Patients with hereditary syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome (for ALL patients only);

patients with intracranial extralateral lesions (cerebrospinal fluid tumor cells and/or intracranial lymphoma invasion shown by MRI) (for NHL patients only) ;

Trial design

Design model

Single group

Treatments tested in this trial

  • CTA101

    Drug

    CTA101 UCAR-T cell injection by intravenous infusion

Treatment groups

72 Participants
are divided into 1 treatment group
Group A: Administration of CTA101Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-limiting toxicity (DLT)

Adverse events assessed according to NCI-CTCAE v5.0 criteria

Time frame
Baseline up to 28 days after CTA101 infusion
2

Incidence of treatment-emergent adverse events (TEAEs)

Incidence of treatment-emergent adverse events \[Safety and Tolerability\]

Time frame
Up to 2 years after CTA101 infusion

Secondary outcomes

1

B-cell acute lymphocytic leukemia (B-ALL), MRD negative overall response rate (MRD- ORR)

Assessment of MRD negative overall response rate (MRD- ORR) at 3 months after CTA101 infusion

Time frame
3 months
2

B-ALL, Event-free survival (EFS)

From the first infusion of CTA101 to the occurrence of any event, including death, relapse or gene relapse, disease progression (any one occurs first), and the last visit

Time frame
Month 6, 12, 18 and 24
3

B-ALL, Overall response rate (ORR)

Assessment of ORR (ORR = CR + CRi ) at Month 6, 12, 18 and 24

Time frame
Month 6, 12, 18 and 24
4

B-ALL, Overall survival (OS)

From the first infusion of CTA101 to death or the last visit

Time frame
Month 6, 12, 18 and 24

Other outcomes

Sponsors and contacts

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

He Huang

Lead sponsor

Zhejiang University

Sponsor institution

Nanjing Bioheng Biotech Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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