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NCT03710421

CS1-CAR T Therapy Following Chemotherapy in Treating Patients With Relapsed or Refractory CS1 Positive Multiple Myeloma

StatusActive, Not Recruiting
PhasePhase 1
Primary completion (estimated)
Track this trial

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Record History

All 18 versions: 16 with changes below, 2 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Trial status changed: Suspended → Active, Not Recruiting
  2. Eligibility criteria expanded, about 22 words
    • Primary and study completion dates: Feb 23, 2027 to Aug 13, 2027
    • Secondary endpoints: details revised at 3 of 7 entries
  3. Recruitment suspended Sponsor's reason: Slow/Low Accrual
    • Site details revised
    v16
  4. Primary and study completion dates: Mar 24, 2026 to Feb 23, 2027v15
  5. Primary and study completion dates: Mar 25, 2025 to Mar 24, 2026v14
Show 10 earlier versionsHide 10 earlier versions
  1. Primary and study completion dates: Feb 13, 2025 to Mar 25, 2025v13
  2. Primary and study completion dates: Dec 10, 2023 to Feb 13, 2025
    • Start date: Feb 13, 2019 to Apr 23, 2019
    v11
  3. Primary and study completion dates: Dec 10, 2021 to Dec 10, 2023v9
  4. Trial status: Suspended to Recruiting
    • Site details revised
    v8
  5. Trial status: Recruiting to Suspended Sponsor's reason: FDA Clinical Hold
    • Site details revised
    v7
  6. Eligibility criteria expanded, about 14 words
    • Secondary endpoints revised (7)
    • Study description revised
    v6
  7. Eligibility criteria expanded, about 37 wordsv5 Show 6 more changesShow less
    • Primary endpoints: 1 to 4
    • Start date: Feb 15, 2019 to Feb 13, 2019
    • Secondary endpoints: 10 to 7
    • Study description revised
    • Site contact updated
    • Study title expanded, about 2 words
  8. Start date changed from estimate of Jun 10, 2019 to Feb 15, 2019v4
  9. Trial status: Not Yet Recruiting to Recruiting
    • Eligibility criteria expanded, about 23 words
    • Study description expanded, about 8 words
    • Site details revised
    v3
  10. Start date: Dec 10, 2018 to Jun 10, 2019v2
  1. Study First Submitted
  • Stopped: terminated, suspended or withdrawn
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Incidence of dose-limiting toxicity (DLT) and all other toxicities
Timeframe: Up to 12 months
Incidence of all other toxicities
Timeframe: Up to 15 years
Opportunistic infections
Timeframe: Up to 15 years
Prolonged lymphopenia (lasting more than 12 weeks)
Timeframe: Up to 15 years

Secondary (7)

Disease response
Expansion/persistence of chimeric antigen receptor (CAR) T cells
Phenotype and anti-tumor functionality of modified T cells in marrow and blood
Cytokine and soluble CS-1 levels in blood and marrow
Disease free survival (DFS)
Show 2 moreShow less
Progression-free survival
CS1 expression on multiple myeloma cells

Arms and interventions

Treatment (leukapheresis, chemotherapy, CS-1 CAR T therapy)Experimental

Patients undergo leukapheresis over 2-4 hours. Beginning 3-4 weeks, patients receive cyclophosphamide IV on days -4 and/or -3 or fludarabine IV and cyclophosphamide IV on days -5 to -3. Patients then undergo CS1-CAR T therapy over 10-15 minutes on day 0.

Procedures: CS1-CAR T Therapy, Leukapheresis

Drugs: Cyclophosphamide, Fludarabine

Sites

1 site in 1 country

  • City of Hope Medical CenterDuarte, California, United States