Autologous CD30.CAR-T in Combination With Nivolumab in cHL Patients After Failure of Frontline Therapy

Part of paid clinical trials in Duarte, California.

Sponsor
Tessa Therapeutics
Study ID
NCT05352828
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Classical Hodgkin Lymphoma
  • Hodgkin Disease Recurrent
  • Hodgkin Disease Refractory

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Dose: 480 mg or 6 mg/kg Q4W
  • Autologous CD30.CAR-T — DRUG
    Dose: 2 x 10e8 cells/m2
  • Fludarabine — DRUG
    Dose: 30 mg/m2/day x 3 days
  • Bendamustine — DRUG
    Dose: 70 mg/m2/day x 3 days

Study Details

This is a Phase 1b, multicenter, open-label, single arm study to evaluate the safety and efficacy of the combination therapy, CD30.CAR-T and the programmed cell death protein-1 (PD-1) checkpoint inhibitor, nivolumab, in patients aged 12 years of age and above with relapsed or refractory classical Hodgkin lymphoma (cHL) following failure of standard frontline therapy.

Key Dates

Start date
Jul 25, 2022
Status verified
Mar 2023
Primary completion
Dec 15, 2025
Completion
Dec 15, 2037

Study Design

Enrollment
15 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab and CD30.CAR-T
    Study treatment will include 4 cycles of nivolumab and a single CD30.CAR-T infusion (preceded by lymphodepletion chemotherapy of Fludarabine and Bendamustine).

Primary Outcome Measure

Safety of autologous CD30.CAR-T in combination with nivolumab [ Time Frame: From first dose of nivolumab (Cycle 1) to end of nivolumab Cycle 4 (each cycle is 28 days) ]

Locations (5)

FacilityCityStateZIPSite coordinators
City of Hope National Medical CenterDuarteCalifornia91010-
University of MiamiMiamiFlorida33136-
UNC Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599-
Baylor College of MedicineHoustonTexas77030-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Duarte, CA

By research site
City of Hope National Medical Center· Duarte, CAUniversity of Miami· Miami, FLUNC Lineberger Comprehensive Cancer Center· Chapel Hill, NCBaylor College of Medicine· Houston, TXMD Anderson Cancer Center· Houston, TX

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