ET190L1-ARTEMIS™ T Cells in Relapsed, Refractory B Cell Leukemia and Lymphoma

NCT03895944 | Unknown Early Phase 1 FDA Drug

• 1 other identifier: XJTU1AF2017LSL-C001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical study to evaluate safety and pharmacokinetics (primary objectives) and efficacy (secondary objective) of ET190L1-ARTEMIS™2 T-cells in patients with Cluster of Differentiation (CD) 19+ B cell Leukemia and Lymphoma

Conditions

CD19+ Lymphoma, B-Cell; CD19+ Leukemia, B-Cell

Outcome Measures

Primary Outcomes (4)

• Frequency of ARTEMIS T cell treatment-related adverse events

  Frequency of treatment-related adverse events that occurred at any time from the first day of infusion that are "possibly", "likely", or "definitely" related to the study, including infusion related toxicity and ET190L1-ARTEMIS™ T T cells related toxicity. Include but not limited to: Fever, chills, nausea, vomiting, jaundice and other gastrointestinal symptoms; Fatigue, hypotension, respiratory distress; Tumor lysis syndrome; Cytokine release syndrome; Neutropenia, thrombocytopenia; Liver and kidney dysfunction. Assessed at all visits.

  until 24 weeks

• Number of ET190L1-ARTEMIS™ T cells in peripheral blood

  Duration of in vivo engraftment of ET190L1-ARTEMIS™ T cells. Number of ET190L1-ARTEMIS™ T cells in peripheral blood will be presented as Time to peak, Time to baseline level and so on.

  24 months

• % of ET190L1-ARTEMIS™ T cells in peripheral blood

  Duration of in vivo engraftment of ET190L1-ARTEMIS™ T cells. % of ET190L1-ARTEMIS™ T cells in peripheral blood will be presented as Time to peak, Time to baseline level and so on.

  24 months

• Maximum Tolerated Dose

  Determine the safety, including potential dose limiting toxicities, of the ET190L1-ARTEMIS™ T cells. A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the ET190L1-ARTEMIS™ T cells, which is irreversible or life threatening or CTCAE Grade 3-5. Assessed at all visits.

  28 days up to 2 years

Secondary Outcomes (9)

• Tmax of serum cytokine levels

  24 weeks

• Time to baseline for serum cytokine levels

  24 weeks

• AUC of serum cytokine levels

  24 weeks

• Rate of disease response

  28 days to 24 months

• Progression free survival (PFS)

  4 months, 1 year and 2 years

Study Arms (3)

iv low dose

EXPERIMENTAL

Autologous ET190L1-ARTEMIS™ T cells administered by intravenous (IV) infusion with low dose (1x10\^6) in Leukemia or Lymphoma patients

Biological: ET190L1-ARTEMIS™ T cells -iv low dose

iv middle dose

EXPERIMENTAL

Autologous ET190L1-ARTEMIS™ T cells administered by intravenous (IV) infusion with middle dose (3x10\^6) in Leukemia or Lymphoma patients

Biological: ET190L1-ARTEMIS™ T cells -iv middle dose

iv high dose

EXPERIMENTAL

Autologous ET190L1-ARTEMIS™ T cells administered by intravenous (IV) infusion with high dose (10x10\^6) in Leukemia or Lymphoma patients

Biological: ET190L1-ARTEMIS™ T cells - iv high dose

Interventions

ET190L1-ARTEMIS™ T cells -iv low dose BIOLOGICAL

Autologous T cells transduced with lentivirus encoding an anti-CD19 (ET190L1) -ARTEMIS™ expression construct, 1x10\^6

iv low dose

ET190L1-ARTEMIS™ T cells -iv middle dose BIOLOGICAL

Autologous T cells transduced with lentivirus encoding an anti-CD19 (ET190L1) -ARTEMIS™ expression construct, 3x10\^6

iv middle dose

ET190L1-ARTEMIS™ T cells - iv high dose BIOLOGICAL

Autologous T cells transduced with lentivirus encoding an anti-CD19 (ET190L1) -ARTEMIS™ expression construct, 10x10\^6

iv high dose

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with relapsed/refractory CD19+ B-cell lymphoma or Leukemia, with no effective therapy available per National Comprehensive Cancer Network (NCCN) guidelines
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2, expected survival time \> 3 months per PIs opinion
• Women of childbearing age should have a negative pregnancy test and agree to use effective contraception during treatment and 1 year after the last dose.
• Peripheral venous access is available and no issues with apheresis for lymphocyte isolation
• serum alanine aminotransferase(ALT)\<200 Unit/L, ALT/Aspartate aminotransferase(AST)\<3 normal range; serum creatinine (Cr)\<2.5mg/dL
• Voluntarily signed informed consent form

You may not qualify if:

• Women in pregnancy and lactation
• Unable to perform leukapheresis and iv infusion
• With active infection
• Major organ failure
• Patients with dependence on corticosteroids
• Continuously used glucocorticoids or other immunosuppressive agents within 2 weeks
• T cell deficiency or T cells are difficult to be transduced
• Patients currently receiving other investigational treatments (biotherapy, chemotherapy, or radiotherapy)

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Eureka Therapeutics Inc.: collaborator

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, 710061, China

RECRUITING

Study Officials

• Mei Zhang, PhD

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mei Zhang, PhD

CONTACT

86-18991232153; prozhangmei@126.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: March 29, 2019
• Study Start: December 6, 2017
• Primary Completion: December 6, 2019
• Study Completion: December 6, 2019
• Last Updated: March 29, 2019

Record last verified: 2019-03

Locations

CN (1)