NCT02081937

Brief Summary

Patients receive anti-CD19-CAR (coupled with CD137 and CD3 zeta signalling domains)vector-transduced autologous T cells over a period of 4 or 5 consecutive days in an escalating dose. After completion of study treatment, patients are followed intensively for 6 months, every 3 months for 2 years, and annually thereafter for 10 years.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2014

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 7, 2014

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 11, 2014

Status Verified

March 1, 2014

Enrollment Period

4.8 years

First QC Date

March 6, 2014

Last Update Submit

March 10, 2014

Conditions

Hematopoietic/Lymphoid CancerNon-hodgkin Lymphoma,B CellMantle Cell Lymphoma

Keywords

chimeric antigen receptorimmunotherapyT lymphocytemantle cell lymphoma

Outcome Measures

Primary Outcomes (1)

  • Occurrence of study related adverse events

    defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to the study.

    Until 2 years

Secondary Outcomes (1)

  • Clinical responses to CART-19 cell therapy

    Until 24 weeks

Study Arms (1)

Anti-CD19 CAR T cells

EXPERIMENTAL

Patients receive anti-CD19-CAR retroviral vector-transduced autologous or donor-derived T cells on d1-5 in the absence of disease progression or unacceptable toxicity.

Biological: anti-CD19-CAR vector-transduced T cells

Interventions

anti-CD19-CAR vector-transduced T cellsBIOLOGICAL
Also known as: Genetically engineered lymphocyte therapy
Anti-CD19 CAR T cells

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female with CD19+ relapsed or refractory MCL, and with no available curative treatment options (such as autologous or allogeneic SCT) who have limited prognosis (several months to \< 2 year survival) with currently available therapies will be enrolled.
  • Not eligible or appropriate for conventional allogeneic SCT
  • Patients who achieve only a partial response to FCR(fludarabine, cyclophosphamide and Rituxan) as initial therapy will be eligible.
  • Beyond 1st CR (complete remission) with relapsed or persistent disease and not eligible or appropriate for conventional allogeneic or autologous SCT
  • Disease responding or stable after most recent therapy (chemotherapy, MoAb, etc...)
  • Relapsed after prior autologous SCT
  • Residual disease after primary therapy and not eligible for autologous SCT
  • Relapsed after prior autologous SCT
  • Beyond 1st CR with relapsed or persistent disease and not eligible or appropriate of conventional allogeneic or autologous SCT
  • Expected survival \> 12 weeks
  • Creatinine \< 2.5 mg/dl
  • ALT(alanine aminotransferase)/AST (aspartate aminotransferase)\< 3x normal
  • Bilirubin \< 2.0 mg/dl
  • Any relapse after prior autologous SCT will make patient eligible regardless of other prior therapy
  • Adequate venous access for apheresis, and no other contraindications for leukapheresis
  • +1 more criteria

You may not qualify if:

  • Pregnant or lactating women. The safety of this therapy on unborn children is not known. Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion.
  • Uncontrolled active infection
  • Active hepatitis B or hepatitis C infection
  • Previously treatment with any gene therapy products
  • Feasibility assessment during screening demonstrates \< 30% transduction of target lymphocytes, or insufficient expansion (\< 5-fold) in response to CD3/CD137 costimulation
  • Any uncontrolled active medical disorder that would preclude participation as outlined
  • HIV infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hematology of Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Hematologic NeoplasmsLymphoma, Mantle-Cell

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Quanshun Wang, Dr.

CONTACT

8610-66939486wqs63@sohu.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 6, 2014

First Posted

March 7, 2014

Study Start

March 1, 2014

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

March 11, 2014

Record last verified: 2014-03

Locations

CN(1)