Last reviewed · How we verify

NCT01653717

CD19-specific T-cell for Chronic Lymphocytic Leukemia (CLL)

Completed Phase 1 Last updated 17 August 2017
What this trial tests

Phase 1 trial testing Leukapheresis in Advanced Cancers in 30 participants. Completed in 7 August 2017.

Timeline
11 June 2013
Primary endpoint
7 August 2017
7 August 2017

Quick facts

Lead sponsorM.D. Anderson Cancer Center
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment30
Start date11 June 2013
Primary completion7 August 2017
Estimated completion7 August 2017
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

Adults 18 to 80, any sex, with Advanced Cancers or Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical research study is to find the highest tolerable dose of T cells that can be given in combination with standard chemotherapy to patients with CLL. The safety of this combination will also be studied. The T cells being used in this study are a type of white blood cell that will be taken from your blood and then genetically changed in a laboratory. The process of changing the DNA (the genetic material of cells) of the T cells is called a gene transfer. After the gene transfer is complete, the genetically changed T-cells will be put back into your body. These T cells may help prevent cancer cells from coming back.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Antibody-modified T cells: CARs take the front seat for hematologic malignancies.
    Maus MV, Grupp SA, Porter DL, June CH. · · 2014 · cited 474× · PMID 24578504 · DOI 10.1182/blood-2013-11-492231
  2. Engineering and Design of Chimeric Antigen Receptors.
    Guedan S, Calderon H, Posey AD, Maus MV. · · 2019 · cited 339× · PMID 30666307 · DOI 10.1016/j.omtm.2018.12.009
  3. Toward eliminating HLA class I expression to generate universal cells from allogeneic donors.
    Torikai H, Reik A, Soldner F, Warren EH, et al · · 2013 · cited 257× · PMID 23741009 · DOI 10.1182/blood-2013-03-478255
  4. Bioengineering T cells to target carbohydrate to treat opportunistic fungal infection.
    Kumaresan PR, Manuri PR, Albert ND, Maiti S, et al · · 2014 · cited 166× · PMID 25002471 · DOI 10.1073/pnas.1312789111
  5. A new approach to gene therapy using Sleeping Beauty to genetically modify clinical-grade T cells to target CD19.
    Singh H, Huls H, Kebriaei P, Cooper LJ. · · 2014 · cited 106× · PMID 24329797 · DOI 10.1111/imr.12137
  6. Human cell-based artificial antigen-presenting cells for cancer immunotherapy.
    Butler MO, Hirano N. · · 2014 · cited 99× · PMID 24329798 · DOI 10.1111/imr.12129
  7. Clinical applications of gamma delta T cells with multivalent immunity.
    Deniger DC, Moyes JS, Cooper LJ. · · 2014 · cited 92× · PMID 25566249 · DOI 10.3389/fimmu.2014.00636
  8. Targeting Natural Killer Cells for Tumor Immunotherapy.
    Zhang C, Hu Y, Shi C. · · 2020 · cited 91× · PMID 32140153 · DOI 10.3389/fimmu.2020.00060

Verify or expand the search:

Other trials of Leukapheresis

Trials testing the same drug.

Other recruiting trials for Advanced Cancers

Currently open trials in the same condition.

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01653717.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing