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JCAR017-BCM-001

AcronymISRCTNEudraCTClinicaltrials.govDRKS
JCAR017-BCM-0012017-000106-38NCT02631044

A Phase 2, Single-Arm, Multi-Cohort, Multi-Center Trial to Determine the Efficacy and Safety of JCAR017 in Adult Subjects with Aggressive B-Cell Non-Hodgkin Lymphoma

Status: Active

Purpose / Objectives

Primary Outcome

  • The primary objective of the study is to determine the efficacy, defined as overall response rate (ORR), of JCAR017 in subjects with aggressive B-cell non-Hodgkin lymphoma.

Secondary Outcomes

  • Evaluate the safety and feasibility of administering JCAR017
  • Evaluate other measures of efficacy of JCAR017
  • Characterize the cellular pharmacokinetic (PK) profile of JCAR017, including the quantity and persistence of the chimeric antigen receptor (CAR) T cells in the peripheral blood and bone marrow
  • Describe changes in health-related quality of life using the European Organisation for Research and Treatment of Cancer – Quality of Life C30 questionnaire (EORTC QLQ-C30) and the European Quality of Life-5 Dimensions health state classifier to 5 Levels (EQ-5D-5L)

Diagnosis

Patient attributes

Age

18-99

Inclusion criteria

  • Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).
  • Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
  • Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
  • Investigator considers the subject is appropriate for adoptive T cell therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
  • Subjects with one of the following:
    • Cohort 1: Subjects with DLBCL NOS (de novo and transformed indolent B-NHL), high grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (double/triple hit lymphoma [DHL/THL]) and follicular lymphoma Grade 3B (FL3B) per WHO 2016 classification (Swerdlow, 2016), after ≥ 2 lines of therapy, including an anthracycline and rituximab (or other CD20-targeted agent)*.
    • Cohort 2: TNE subjects with DLBCL NOS (de novo and transformed indolent BNHL), high grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (double/triple hit lymphoma [DHL/THL]) and follicular lymphoma Grade 3B (FL3B) per WHO 2016 classification (Swerdlow, 2016), after an anthracycline and rituximab (or other CD20-targeted agent) containing first line therapy. TNE subjects may include those who are unsuitable for stem cell transplantation (SCT) due to other medical conditions, age, subject choice, financial constraints or other reasons as determined by the Investigator. Comorbities in this
      cohort will be evaluated using the HCT-CI (Sorror, 2005).
    • Cohort 3 (Japan only): Subjects with DLBCL NOS (de novo and transformed indolent B-NHL), high grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (double/triple hit lymphoma [DHL/THL]) and follicular lymphoma Grade 3B (FL3B) per WHO 2016 classification (Swerdlow, 2016), after ≥ 2 lines of therapy, including an anthracycline and rituximab (or other CD20-targeted agent)*.
    • Cohort 4: Subjects with high grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (double/triple hit lymphoma [DHL/THL]) who failed initial therapy*. Subjects may be screened at initial diagnosis and leukapheresis performed prior to initiation of first line therapy.
    • Cohort 5: Subjects with PCNSL and subjects with CNS involvement of DLBCL after ≥ 2 lines of therapy*.
    • Cohort 6: Subjects with Richter’s transformation after ≥ 2 lines of therapy for Richter’s transformation*.
    • Histological confirmation of diagnosis at last relapse. Enough tumor material must be available for central confirmation of diagnosis, otherwise a new tumor biopsy is mandated.
  • [...]

Exclusion criteria

  • Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
  • Subject has any condition including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if participating in the study.
  • Subject has any condition that confounds the ability to interpret data from the study.
  • Subjects with T cell rich/histiocyte rich large B-cell lymphoma (THRBCL), primary cutaneous large B-cell lymphoma, primary mediastinal B-cell lymphoma (PMBCL), EBV positive DLBCL of the elderly and Burkitt lymphoma.
  • History of another primary malignancy that has not been in remission for at least 2 years prior to enrollment. The following are exempt from the 2-year limit if curatively treated:
    • Non-melanoma skin cancer
    • Localized prostate cancer
    • Cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear
  • Treatment with any prior gene therapy product.
  • [...]

Trial design

  • Phase II
  • Multicenter
  • Prospective
  • One-arm

Intervention

  • Study JCAR017-BCM-001 is a single-arm, multi-cohort, multi-center, Phase 2 study to determine the efficacy and safety of JCAR017 in subjects with aggressive B-cell NHL (B-NHL).
  • Approximately 124 subjects will be enrolled into one of 6 cohorts as listed below.

Documents (password protected)

Responsibilities in overall trial

National Coordinating Investigator

Prof. Dr. med. Peter Borchmann

Study Sites

Klinik I für Innere Medizin

Study office

  • Klinisches Studienzentrum der Klinik I für Innere Medizin Köln

Status

Active

Principal Investigator

Prof. Dr. med. Peter Borchmann

Deputy of Principal Investigator

  • PD Dr. Dr. med. Udo Holtick

Subinvestigator

  • PD Dr. med. Boris Böll
  • Dr. Philipp Gödel
  • Dr. med. Anja Jühling
  • Dr. med. Armin Tuchscherer

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