NCT03097770

Brief Summary

RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous or donor-derived T cells may make the body build immune response to kill cancer cells. PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in treating patients with B-cell leukemia or lymphoma that is relapsed (after stem cell transplantation or intensive chemotherapy) or refractory to chemotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2017

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 26, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 31, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

September 2, 2020

Status Verified

December 1, 2019

Enrollment Period

2.1 years

First QC Date

March 26, 2017

Last Update Submit

August 31, 2020

Conditions

Hematopoietic/Lymphoid CancerAdult Acute Lymphoblastic Leukemia in RemissionB-cell Adult Acute Lymphoblastic LeukemiaB-cell Chronic Lymphocytic LeukemiaProlymphocytic LeukemiaRecurrent Adult Diffuse Large Cell LymphomaRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Grade 3 Follicular LymphomaRecurrent Mantle Cell LymphomaRefractory Chronic Lymphocytic LeukemiaStage III Adult Diffuse Large Cell LymphomaStage III Chronic Lymphocytic LeukemiaStage III Grade 1 Follicular LymphomaStage III Grade 2 Follicular LymphomaStage III Grade 3 Follicular LymphomaStage III Mantle Cell LymphomaStage IV Adult Diffuse Large Cell LymphomaStage IV Chronic Lymphocytic LeukemiaStage IV Grade 1 Follicular LymphomaStage IV Grade 2 Follicular LymphomaStage IV Grade 3 Follicular LymphomaStage IV Mantle 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 study treatment

    Until week 24

Secondary Outcomes (1)

  • Anti-tumor responses to tanCART19/20 cell infusions

    up to 96 weeks

Other Outcomes (1)

  • In vivo existence of TanCART19/20

    2 years

Study Arms (1)

anti-CD19/20 CAR T cells

EXPERIMENTAL

Patients receive anti-CD19/20-CAR retroviral vector-transduced autologous or donor-derived T cells on day 1 in the absence of disease progression or unacceptable toxicity.

Biological: anti-CD19/20-CAR vector-transduced T cells

Interventions

anti-CD19/20-CAR vector-transduced T cellsBIOLOGICAL

genetically engineered lymphocyte therapy

Also known as: genetically engineered lymphocyte therapy
anti-CD19/20 CAR T cells

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 and ≤70 years.
  • Performance status (ECOG) between 0 and 2.
  • Histologically confirmed CD20+ and/or CD19+ B-cell non-Hodgkin lymphoma (NHL), including the following types defined by WHO 2008:
  • DLBCL not otherwise specified, DLBCL associated with chronic inflammation, and Epstein-Barr virus (EBV)+ DLBCL in the elderly.
  • Primary mediastinal (thymic) large B-cell lymphoma (PMBCL). The mediastinal mass had to have an axial diameter \<5 cm or extranodal lesion size \<3 cm. Patients with large lesions (≥5 cm) were enrolled in our other clinical trial (NCT0334662).
  • Transformed FL (tFL) .
  • FL.
  • Some indolent lymphomas including MCL and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
  • Refractory disease or relapsed after treatment with ≥2 lines of chemotherapy including rituximab and anthracycline and either having failed autologous HSCT or being ineligible for or not consenting to autologous HSCT.
  • We defined chemotherapy-refractory disease as meeting one or more of the following criteria:
  • No response to first-line therapy (primary refractory disease).
  • No response to second-line or later therapy.
  • PD as the best response to the most recent therapy regimen.
  • Stable disease (SD) as the best response after at least 2 cycles of the most recent line of therapy with a SD duration of no longer than 6 months from the last dose of therapy.
  • Failure following autologous HSCT was defined as follows:
  • +18 more criteria

You may not qualify if:

  • Patients eligible for this study must not meet any of the following criteria:
  • Patients with definite involvement of gastrointestinal tract. Endoscopy should be performed to conform gastrointestinal involvement for patients suspected. However, patients with central nervous system (CNS) involvement were cautiously enrolled in this clinical study.
  • CD19 CAR T cell treatment failure or recurrence, detection of a clear HAMA effect, or negative tumour puncture detection of CD19 and CD20.
  • Pregnant or lactating women.
  • Uncontrolled active bacterial or viral infection. (active hepatitis B or hepatitis C infection, HIV infection) or treponema pallidum infection.
  • Class III/IV cardiovascular disability according to the New York Heart Association Classification and a cardiac ejection fraction ≥50%.
  • History of allogeneic stem cell transplantation.
  • Any autoimmune disease or primary immunodeficiency.
  • Requirement for urgent therapy due to tumour mass effects such as respiratory obstruction or blood vessel compression.
  • Current or expected need for systemic corticosteroid therapy.
  • Any organ failure.
  • The patients with the second tumour requiring for therapy or intervention.
  • Subjects considered unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation according to the investigator's judgement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biotherapeutic Department and Pediatrics Department of Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Related Publications (1)

  • Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.

    PMID: 34515338DERIVED

MeSH Terms

Conditions

Hematologic NeoplasmsLeukemia, Lymphocytic, Chronic, B-CellLeukemia, ProlymphocyticLymphoma, Large B-Cell, DiffuseLymphoma, FollicularLymphoma, Mantle-Cell

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, B-CellLymphoma, Non-HodgkinLymphoma

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
PI

Study Record Dates

First Submitted

March 26, 2017

First Posted

March 31, 2017

Study Start

April 1, 2017

Primary Completion

May 10, 2019

Study Completion

January 31, 2020

Last Updated

September 2, 2020

Record last verified: 2019-12

Locations

CN(1)