Genetically Engineered Lymphocyte Therapy in Treating Patients With Lymphoma That is Resistant or Refractory to Chemotherapy
Pilot Study of Redirected Autologous T Cells Transduced to Express A CD20-Specific Chimeric Immunoreceptor in Patient With Chemotherapy Resistant or Refractory CD20+ Leukemia and Lymphoma
1 other identifier
interventional
50
1 country
1
Brief Summary
RATIONALE: Placing a gene that has been created in the laboratory into white blood cells may make the body build an 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 resistant or refractory to chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2013
Longer than P75 for phase_1
1 active site
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
November 23, 2012
CompletedFirst Posted
Study publicly available on registry
November 28, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedSeptember 29, 2015
September 1, 2015
4.3 years
November 23, 2012
September 27, 2015
Conditions
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 CART-20 cell infusions
Baseline and post-infusion
Study Arms (1)
anti-CD20-CAR T cell
EXPERIMENTALArm 1 Patients receive anti-CD20-CAR lentiviral vector-transduced autologous T cells with 41BB vector for 3-5 days in the absence of disease progression or unacceptable toxicity.
Interventions
anti-CD20-CAR vector-transduced autologous T cells
genetically engineered lymphocyte therapy
Eligibility Criteria
You may qualify if:
- Male and female subjects with CD20+ B cell malignancies in patients 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
- CD20+ leukemia or lymphoma
- ALL in CR2 or CR3 and not eligible for allogeneic SCT because of age, comorbid disease, or lack of available family member or unrelated donor
- Follicular lymphoma, previously identified as CD20+:
- At least 2 prior combination chemotherapy regimens (not including single agent monoclonal antibody (Rituxan) therapy
- Stage III-IV disease
- Less than 1 year between last chemotherapy and progression (i.e. most recent progression free interval \< 1 year)
- Disease responding or stable after most recent therapy (chemotherapy, MoAb, etc)
- CLL:
- At least 2 prior chemotherapy regimens (not including single agent monoclonal antibody (Rituxan) therapy. Patients with high risk disease manifested by deletion chromosome 17p will be eligible if they fail to achieve a CR to initial therapy or progress within 2 years of 1 prior
- Less than 2 years between last chemotherapy and progression (i.e. most recent progression free interval \< 2 years)
- Not eligible or appropriate for conventional allogeneic SCT
- Patients who achieve only a partial response to FCR as initial therapy will be eligible.
- Mantle cell lymphoma:
- Beyond 1st CR with relapsed or persistent disease and not eligible or appropriate for conventional allogeneic or autologous SCT
- +14 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/CD28 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)
Biotherapeutic Department of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
Related Publications (3)
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: 34515338DERIVEDZhang WY, Wang Y, Guo YL, Dai HR, Yang QM, Zhang YJ, Zhang Y, Chen MX, Wang CM, Feng KC, Li SX, Liu Y, Shi FX, Luo C, Han WD. Treatment of CD20-directed Chimeric Antigen Receptor-modified T cells in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: an early phase IIa trial report. Signal Transduct Target Ther. 2016 Mar 11;1:16002. doi: 10.1038/sigtrans.2016.2. eCollection 2016.
PMID: 29263894DERIVEDWang Y, Zhang WY, Han QW, Liu Y, Dai HR, Guo YL, Bo J, Fan H, Zhang Y, Zhang YJ, Chen MX, Feng KC, Wang QS, Fu XB, Han WD. Effective response and delayed toxicities of refractory advanced diffuse large B-cell lymphoma treated by CD20-directed chimeric antigen receptor-modified T cells. Clin Immunol. 2014 Dec;155(2):160-75. doi: 10.1016/j.clim.2014.10.002. Epub 2014 Oct 16.
PMID: 25444722DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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
November 23, 2012
First Posted
November 28, 2012
Study Start
January 1, 2013
Primary Completion
May 1, 2017
Study Completion
October 1, 2018
Last Updated
September 29, 2015
Record last verified: 2015-09