Study of KTE-X19 in Minimal Residual Disease (MRD) Positive B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT06144606
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Tecartus — DRUG
    Tecartus is a CD19 directed CAR T-cell therapy that utilizes CD28 costimulatory and CD3 zeta stimulatory domains. Tecartus is manufactured from purified autologous T-cells via retroviral transduction with a median time to product release of 13 days.

Study Details

This is a Phase 2 Study is to determine the efficacy and safety rate of B-Cell Acute Lymphoblastic Leukemia (B-ALL) participants in remission with minimal residual disease (MRD) after KTE-X19 CAR T-cell therapy

Key Dates

Start date
Dec 26, 2023
Status verified
Mar 2026
Primary completion
Nov 15, 2028
Completion
Nov 15, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Autologous CAR T-cell immunotherapy
    Tecartus will be delivered at a target dose of 1x106 cells / kg. For those \>100 kg, a flat dose of 1 x108 cells will be used. Tecartus will be administered on day 0, following 1 day of rest from conditioning chemotherapy.

Primary Outcome Measure

Relapse Free Survival (RFS) [ Time Frame: Up to 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Bijal D. Shah, MD (PRINCIPAL_INVESTIGATOR)
Rawan Faramand, MD (SUB_INVESTIGATOR)
Leidy Isenalumhe, MD (SUB_INVESTIGATOR)
Frederick Locke, MD (SUB_INVESTIGATOR)

Find similar trials in Tampa, FL

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Moffitt Cancer Center· Tampa, FL

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