Treatment of Relapsed and/or Chemotherapy Refractory B-cell Malignancy by CART19
CART19
Clinical Study of Chimeric CD(Cluster of Differentiation)19 Antigen Receptor-modified T Cells in Relapsed and/or Chemotherapy Refractory B-cell Leukemias and Lymphomas
1 other identifier
interventional
12
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2013
Longer than P75 for not_applicable
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
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 20, 2013
CompletedFirst Posted
Study publicly available on registry
May 30, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedJanuary 28, 2016
January 1, 2016
4 years
May 20, 2013
January 26, 2016
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-19 cell infusions
up to 24 weeks
Other Outcomes (1)
in vivo existence of CART19
1 year
Study Arms (1)
anti-CD19 CAR T cells
EXPERIMENTALPatients receive anti-CD19-CAR retroviral vector-transduced autologous or donor-derived T cells on days 0,1, 2 in the absence of disease progression or unacceptable toxicity.
Interventions
genetically engineered lymphocyte therapy
Eligibility Criteria
You may qualify if:
- Male and female subjects with CD19+ 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
- CD19+ leukemia or lymphoma
- ALL in CR2(second complete remission) or CR3(third complete remission) 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 CD19+:
- 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(fludarabine, cyclophosphamide and Rituxan) as initial therapy will be eligible.
- Mantle cell lymphoma:
- Beyond 1st CR (complete remission) 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/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)
Biotherapeutic Department and Pediatrics Department of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
Related Publications (2)
Zhang WY, Liu Y, Wang Y, Nie J, Guo YL, Wang CM, Dai HR, Yang QM, Wu ZQ, Han WD. Excessive activated T-cell proliferation after anti-CD19 CAR T-cell therapy. Gene Ther. 2018 Jun;25(3):198-204. doi: 10.1038/s41434-017-0001-8. Epub 2018 Mar 29.
PMID: 29599530DERIVEDDai H, Zhang W, Li X, Han Q, Guo Y, Zhang Y, Wang Y, Wang C, Shi F, Zhang Y, Chen M, Feng K, Wang Q, Zhu H, Fu X, Li S, Han W. Tolerance and efficacy of autologous or donor-derived T cells expressing CD19 chimeric antigen receptors in adult B-ALL with extramedullary leukemia. Oncoimmunology. 2015 May 26;4(11):e1027469. doi: 10.1080/2162402X.2015.1027469. eCollection 2015 Nov.
PMID: 26451310DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- 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
May 20, 2013
First Posted
May 30, 2013
Study Start
April 1, 2013
Primary Completion
April 1, 2017
Study Completion
April 1, 2017
Last Updated
January 28, 2016
Record last verified: 2016-01