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 — BIOLOGICALThis 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 1Dose escalation will determine maximum tolerated dose
Primary Outcome Measure
Maximum Tolerated Dose (MDT) [ Time Frame: up to 2 years ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Roswell Park Comprehensive Cancer Center | Buffalo | New York | 14263 | - |
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