A Study of CTA101 UCAR-T Cell Injection in Patients With Relapsed or Refractory CD19+ B-line Hematological Malignancy
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
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
Treatments tested in this trial
- CTA101
Treatment groups
72 Participants
are divided into 1 treatment groupSponsors and collaborators
He Huang
Lead sponsor
Zhejiang University
Sponsor institution
Nanjing Bioheng Biotech Co., Ltd.
Collaborator
Source ClinicalTrials.gov