Last reviewed · How we verify

NCT01892293

CT Antigen TCR-Engineered T Cells for Myeloma

Terminated Phase 1, PHASE2 Results posted Last updated 10 January 2019
What this trial tests

Phase 1, PHASE2 trial testing Treatment with NY-ESO-1c259-modified T cells in Multiple Myeloma in 6 participants. Terminated before completion.

Timeline
15 October 2013
Primary endpoint
10 December 2014
9 April 2018

Quick facts

Lead sponsorAdaptimmune
PhasePhase 1, PHASE2
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment6
Start date15 October 2013
Primary completion10 December 2014
Estimated completion9 April 2018
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Adaptimmune — full company profile →

Who can join

Adults 18 to 80, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Adverse Events Related to Study Treatment Primary · Up to 12 months

Number of Participants with NCI CTCAE Version 4.0 Adverse Events related to study treatment greater than or equal to Grade 3

GroupValue95% CI
NY-ESO-1ᶜ²⁵⁹T Cells Administered IV2
Evaluate the Direct Anti-tumor Activity of NY-ESO-1ᶜ²⁵⁹T Secondary · 180 days

Number of participants with response post-infusion as assessed by international uniform response criteria

GroupValue95% CI
NY-ESO-1ᶜ²⁵⁹T Cells Administered IV0
Peak Persistence of Modified T-cells in the Peripheral Blood Secondary · Days 1, 3, 5, 8, 15, 22, 29, 43, 101, 130 181, every 3 months thereafter

Measurement of NY-ESO-1ᶜ²⁵⁹T cells in blood (copies of WPRE per µg of genomic PBMC DNA)

GroupValue95% CI
NY-ESO-1ᶜ²⁵⁹T Cells Administered IV29,1794479 – 53,879

Adverse events — posted to ClinicalTrials.gov

Time frame: Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

NY-ESO-1ᶜ²⁵⁹T Cells Administered IV
Serious: 1/2 (50%)
Deaths: 2/2

Serious adverse events (1 terms)

ReactionSystemNY-ESO-1ᶜ²⁵⁹T Cells Admini…
Humerus fractureInjury, poisoning and procedural complications
Other adverse events (11 terms — click to expand)

ReactionSystemNY-ESO-1ᶜ²⁵⁹T Cells Admini…
White blood cell count decreasedInvestigations
Lymphocyte count decreasedInvestigations
Neutrophil count decreasedInvestigations
AnemiaBlood and lymphatic system disorders
Aspartate aminotransferase increasedInvestigations
Benign neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps)
FatigueGeneral disorders
HypercalcemiaMetabolism and nutrition disorders
HypertensionVascular disorders
HypertriglyceridemiaMetabolism and nutrition disorders
Sinus bradycardiaCardiac disorders

Most-reported serious reactions: Humerus fracture.

Data from ClinicalTrials.gov NCT01892293 adverse events section.

Sponsor's own description

This study will enroll patients with multiple myeloma who have received prior therapy for their disease but their disease has progressed or relapsed.

Publications & conference data

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

  1. Engineered T cells: the promise and challenges of cancer immunotherapy.
    Fesnak AD, June CH, Levine BL. · · 2016 · cited 812× · PMID 27550819 · DOI 10.1038/nrc.2016.97
  2. NY-ESO-1 Based Immunotherapy of Cancer: Current Perspectives.
    Thomas R, Al-Khadairi G, Roelands J, Hendrickx W, et al · · 2018 · cited 298× · PMID 29770138 · DOI 10.3389/fimmu.2018.00947
  3. Adoptive immunotherapy for cancer or viruses.
    Maus MV, Fraietta JA, Levine BL, Kalos M, et al · · 2014 · cited 221× · PMID 24423116 · DOI 10.1146/annurev-immunol-032713-120136
  4. Driving gene-engineered T cell immunotherapy of cancer.
    Johnson LA, June CH. · · 2017 · cited 211× · PMID 28025979 · DOI 10.1038/cr.2016.154
  5. The Emerging World of TCR-T Cell Trials Against Cancer: A Systematic Review.
    Zhang J, Wang L. · · 2019 · cited 115× · PMID 30798772 · DOI 10.1177/1533033819831068
  6. Engineered T cells for cancer therapy.
    June CH, Maus MV, Plesa G, Johnson LA, et al · · 2014 · cited 85× · PMID 24943274 · DOI 10.1007/s00262-014-1568-1
  7. Synthetic biology in cell-based cancer immunotherapy.
    Chakravarti D, Wong WW. · · 2015 · cited 55× · PMID 26088008 · DOI 10.1016/j.tibtech.2015.05.001
  8. Targeting CD8+ T-cell tolerance for cancer immunotherapy.
    Jackson SR, Yuan J, Teague RM. · · 2014 · cited 40× · PMID 25290416 · DOI 10.2217/imt.14.51

Verify or expand the search:

Other recruiting trials for Multiple Myeloma

Currently open trials in the same condition.

Other Adaptimmune 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/NCT01892293.

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