NCT02822326

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of chimeric antigen receptor 19 (CD19-CAR-T2 Cells) infusions in patients with chemotherapy resistant or refractory CD19+ acute Leukemia.

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
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2016

Typical duration 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

January 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 4, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

September 11, 2017

Status Verified

September 1, 2017

Enrollment Period

3.7 years

First QC Date

June 28, 2016

Last Update Submit

September 8, 2017

Conditions

Acute Leukemia

Keywords

LeukemiaCART CD19Chemotherapy ResistantChemotherapy RefractoryCD19 +Lymphoma

Outcome Measures

Primary Outcomes (1)

  • The maximum tolerated dose(MTD) of CD19 positive relapsed/ refractory acute leukimia treated wtih CD19-CAR-T2 cells

    24 weeks

Secondary Outcomes (2)

  • Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

    12 months

  • Overall Response Rate

    12 months

Study Arms (1)

CD19-CAR-T2 T Cells

EXPERIMENTAL

The subject's T cells will be modified to those which could identify and kill the tumor cells (CD19+ cells). These CD19-CAR-T2 T cells will be infused over 10-15 minutes on days Day 1, 2 and 3 tentatively according to the response to infusion.

Biological: CD19-CAR-T2 Cells

Interventions

CD19-CAR-T2 CellsBIOLOGICAL
CD19-CAR-T2 T Cells

Eligibility Criteria

Age14 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with relapsed and/or refractory CD19 positive B-cell acute leukemia
  • Eastern Cooperative Oncology Group (ECOG) performance status 《 3
  • ALT/ AST 《 3x normal
  • Bilirubin \< 2.0 mg/dl
  • Creatinine \< 2.5 mg/dl and less than 2.5x normal for age
  • LVEF》 45%
  • Accept white blood cell collection
  • Provide informed consent

You may not qualify if:

  • Previous treatment with investigational gene or cell therapy medicine products
  • Solitary extramedullary relapse
  • Active hepatitis B , hepatitis C or HIV infection
  • Uncontrolled active infection
  • Presence of grade 2-4 acute or extensive chronic GVHD
  • Active CNS involvement: epilepsy, paresis, aphasia, stroke, severe head trauma,
  • Dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, etc.
  • Any uncontrolled active medical disorder that would preclude participation as outlined.
  • Received non-diagnostic purposes major surgery within the past 4 weeks
  • Participated in any other clinical study within the past 4 weeks
  • Used murine biological products (except blinatumomab), unless it is proved no anti-mouse antibodies exist.
  • Pregnancy or breast-feeding women
  • Use of prohibited drugs:
  • Steroids: Therapeutic doses of steroids must be stopped \> 72 hours prior to CD19-CAR-T2 Cells infusion
  • Allogeneic cellular therapy: Any donor lymphocyte infusions (DLI) must be completed \> 4 weeks prior to CD19-CAR-T2 Cells infusion
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

Related Publications (13)

  • Hunger SP, Lu X, Devidas M, Camitta BM, Gaynon PS, Winick NJ, Reaman GH, Carroll WL. Improved survival for children and adolescents with acute lymphoblastic leukemia between 1990 and 2005: a report from the children's oncology group. J Clin Oncol. 2012 May 10;30(14):1663-9. doi: 10.1200/JCO.2011.37.8018. Epub 2012 Mar 12.

    PMID: 22412151BACKGROUND

  • Raetz EA, Bhatla T. Where do we stand in the treatment of relapsed acute lymphoblastic leukemia? Hematology Am Soc Hematol Educ Program. 2012;2012:129-36. doi: 10.1182/asheducation-2012.1.129.

    PMID: 23233571BACKGROUND

  • Pulte D, Redaniel MT, Jansen L, Brenner H, Jeffreys M. Recent trends in survival of adult patients with acute leukemia: overall improvements, but persistent and partly increasing disparity in survival of patients from minority groups. Haematologica. 2013 Feb;98(2):222-9. doi: 10.3324/haematol.2012.063602. Epub 2012 Aug 28.

    PMID: 22929974BACKGROUND

  • Schrappe M, Hunger SP, Pui CH, Saha V, Gaynon PS, Baruchel A, Conter V, Otten J, Ohara A, Versluys AB, Escherich G, Heyman M, Silverman LB, Horibe K, Mann G, Camitta BM, Harbott J, Riehm H, Richards S, Devidas M, Zimmermann M. Outcomes after induction failure in childhood acute lymphoblastic leukemia. N Engl J Med. 2012 Apr 12;366(15):1371-81. doi: 10.1056/NEJMoa1110169.

    PMID: 22494120BACKGROUND

  • Forman SJ, Rowe JM. The myth of the second remission of acute leukemia in the adult. Blood. 2013 Feb 14;121(7):1077-82. doi: 10.1182/blood-2012-08-234492. Epub 2012 Dec 14.

    PMID: 23243288BACKGROUND

  • Jensen MC, Popplewell L, Cooper LJ, DiGiusto D, Kalos M, Ostberg JR, Forman SJ. Antitransgene rejection responses contribute to attenuated persistence of adoptively transferred CD20/CD19-specific chimeric antigen receptor redirected T cells in humans. Biol Blood Marrow Transplant. 2010 Sep;16(9):1245-56. doi: 10.1016/j.bbmt.2010.03.014. Epub 2010 Mar 19.

    PMID: 20304086BACKGROUND

  • Savoldo B, Ramos CA, Liu E, Mims MP, Keating MJ, Carrum G, Kamble RT, Bollard CM, Gee AP, Mei Z, Liu H, Grilley B, Rooney CM, Heslop HE, Brenner MK, Dotti G. CD28 costimulation improves expansion and persistence of chimeric antigen receptor-modified T cells in lymphoma patients. J Clin Invest. 2011 May;121(5):1822-6. doi: 10.1172/JCI46110. Epub 2011 Apr 11.

    PMID: 21540550BACKGROUND

  • Chimeric Antigen Receptor-Modified T Cells in Chronic Lymphoid Leukemia; Chimeric Antigen Receptor-Modified T Cells for Acute Lymphoid Leukemia; Chimeric Antigen Receptor T Cells for Sustained Remissions in Leukemia. N Engl J Med. 2016 Mar 10;374(10):998. doi: 10.1056/NEJMx160005. No abstract available.

    PMID: 26962747BACKGROUND

  • Porter DL, Hwang WT, Frey NV, Lacey SF, Shaw PA, Loren AW, Bagg A, Marcucci KT, Shen A, Gonzalez V, Ambrose D, Grupp SA, Chew A, Zheng Z, Milone MC, Levine BL, Melenhorst JJ, June CH. Chimeric antigen receptor T cells persist and induce sustained remissions in relapsed refractory chronic lymphocytic leukemia. Sci Transl Med. 2015 Sep 2;7(303):303ra139. doi: 10.1126/scitranslmed.aac5415.

    PMID: 26333935BACKGROUND

  • Maude SL, Frey N, Shaw PA, Aplenc R, Barrett DM, Bunin NJ, Chew A, Gonzalez VE, Zheng Z, Lacey SF, Mahnke YD, Melenhorst JJ, Rheingold SR, Shen A, Teachey DT, Levine BL, June CH, Porter DL, Grupp SA. Chimeric antigen receptor T cells for sustained remissions in leukemia. N Engl J Med. 2014 Oct 16;371(16):1507-17. doi: 10.1056/NEJMoa1407222.

    PMID: 25317870BACKGROUND

  • Kochenderfer JN, Dudley ME, Kassim SH, Somerville RP, Carpenter RO, Stetler-Stevenson M, Yang JC, Phan GQ, Hughes MS, Sherry RM, Raffeld M, Feldman S, Lu L, Li YF, Ngo LT, Goy A, Feldman T, Spaner DE, Wang ML, Chen CC, Kranick SM, Nath A, Nathan DA, Morton KE, Toomey MA, Rosenberg SA. Chemotherapy-refractory diffuse large B-cell lymphoma and indolent B-cell malignancies can be effectively treated with autologous T cells expressing an anti-CD19 chimeric antigen receptor. J Clin Oncol. 2015 Feb 20;33(6):540-9. doi: 10.1200/JCO.2014.56.2025. Epub 2014 Aug 25.

    PMID: 25154820BACKGROUND

  • Lee DW, Kochenderfer JN, Stetler-Stevenson M, Cui YK, Delbrook C, Feldman SA, Fry TJ, Orentas R, Sabatino M, Shah NN, Steinberg SM, Stroncek D, Tschernia N, Yuan C, Zhang H, Zhang L, Rosenberg SA, Wayne AS, Mackall CL. T cells expressing CD19 chimeric antigen receptors for acute lymphoblastic leukaemia in children and young adults: a phase 1 dose-escalation trial. Lancet. 2015 Feb 7;385(9967):517-528. doi: 10.1016/S0140-6736(14)61403-3. Epub 2014 Oct 13.

    PMID: 25319501BACKGROUND

  • Weng J, Lai P, Qin L, Lai Y, Jiang Z, Luo C, Huang X, Wu S, Shao D, Deng C, Huang L, Lu Z, Zhou M, Zeng L, Chen D, Wang Y, Chen X, Geng S, Robert W, Tang Z, He C, Li P, Du X. A novel generation 1928zT2 CAR T cells induce remission in extramedullary relapse of acute lymphoblastic leukemia. J Hematol Oncol. 2018 Feb 20;11(1):25. doi: 10.1186/s13045-018-0572-x.

    PMID: 29458388DERIVED

MeSH Terms

Conditions

LeukemiaLymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Jianyu Weng, Dr.

    Guangdong Provincial People's Hospital

    PRINCIPAL INVESTIGATOR

  • Peilong Lai, Dr.

    Guangdong Provincial People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Du, Dr.

CONTACT

+86 20 83827812miyadu@hotmial.com

Peng Li, Dr.

CONTACT

+86 20 32015300li_peng@gibh.ac.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2016

First Posted

July 4, 2016

Study Start

January 1, 2016

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

September 11, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)