Phase I/II Study of Rapcabtagene Autoleucel in CLL, 3L+ DLBCL, r/r ALL and 1L HR LBCL

Part of paid clinical trials in Los Angeles, California.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT03960840
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Rapcabtagene autoleucel single agent — BIOLOGICAL
    Single infusion of rapcabtagene autoleucel
  • Ibrutinib — DRUG
    Tablets or capsules for oral daily use

Study Details

This is a phase I/II study to evaluate the feasibility, safety and preliminary antitumor efficacy of rapcabtagene autoleucel (also known as YTB323). Rapcabtagene autoleucel will be investigated in combination with ibrutinib in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and as single agent in diffuse large B-cell lymphoma (3L+ DLBCL), adult acute lymphoblastic leukemia (ALL) and 1st Line High Risk Large B-Cell Lymphoma (1L HR LBCL).

Key Dates

Start date
Jun 26, 2019
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
May 31, 2028

Study Design

Enrollment
217 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: CLL/SLL
    Dose escalation of rapcabtagene autoleucel in combination with ibrutinib
  • Experimental: 3L+ DLBCL
    Dose escalation and expansion of rapcabtagene autoleucel single agent in 3L+ DLBCL
  • Experimental: Adult ALL
    Dose escalation of rapcabtagene autoleucel single agent in adult ALL
  • Experimental: 1L HR LBCL
    Rapcabtagene autoleucel single agent in 1L HR LBCL

Primary Outcome Measure

Phase 1: Dose recommendation: Incidence and nature of Dose Limiting Toxicities (Dose Escalation part only) [ Time Frame: 28 days ]

Locations (12)

FacilityCityStateZIPSite coordinators
University of California LALos AngelesCalifornia90095-
Stanford University Medical CenterStanfordCalifornia94305-5826-
H Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-
Uni of Chi Medi Ctr Hema and OncoChicagoIllinois60637-
University of Kansas Cancer CenterWestwoodKansas66205-
Mass Gen Hosp Cancer CenterBostonMassachusetts02114-
University of Pennsylvania ClinicalPhiladelphiaPennsylvania19104-
Sarah Cannon Research InstituteNashvilleTennessee37221-
Tennessee OncologyNashvilleTennessee37203-
St Davids South Austin Medical CtrAustinTexas78704-
Uni Of TX MD Anderson Cancer CntrHoustonTexas77030-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Los Angeles, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of California LA· Los Angeles, CAStanford University Medical Center· Stanford, CAH Lee Moffitt Cancer Center and Research Institute· Tampa, FLUni of Chi Medi Ctr Hema and Onco· Chicago, ILUniversity of Kansas Cancer Center· Westwood, KSMass Gen Hosp Cancer Center· Boston, MA

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