A Phase I Trial of Bispecific CD19/CD20-Targeted Chimeric Antigen Receptor (CAR) Modified T Cells With 4-1BB and Mutated CD28 Costimulatory Domains in Patients With Relapsed or Refractory CD19+ Hematologic Malignancies

Part of paid clinical trials in Buffalo, New York.

Sponsor
Roswell Park Cancer Institute
Study ID
NCT07701889
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Hematologic Diseases

Eligibility Criteria

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

Interventions

  • 20-19 Tan BB06oz CAR T — BIOLOGICAL
    This investigational product is a genetically modified chimeric antigen receptor t-cell product expressing a biospecific anti CD19/CD20 and incorporating both 4-1BB and mutated CD28 costimulatory domains.

Study Details

To determine the safety, toxicity, and maximum tolerated dose (MTD) of CD19/CD20 bispecific CAR-T cells with 4-1BB and mutated CD28 costimulatory domains (20-19 Tan BB06z) in patients with relapsed or refractory CD19+ aggressive hematologic malignancies

Key Dates

First listed
Jul 14, 2026
Start date
Oct 31, 2026
Status verified
Jul 2026
Primary completion
Oct 31, 2028
Completion
Oct 31, 2029

Study Design

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

Arms

  • Experimental: Arm 1
    Dose escalation will determine maximum tolerated dose

Primary Outcome Measure

Maximum Tolerated Dose (MDT) [ Time Frame: up to 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Roswell Park Comprehensive Cancer CenterBuffaloNew York14263-

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