Dose Escalation/Dose Expansion Study of PRGN-3007 UltraCAR-T Cells in Patients With Advanced Hema… (NCT05694364) | Clinical Trial Compass
CompletedPhase 1
Dose Escalation/Dose Expansion Study of PRGN-3007 UltraCAR-T Cells in Patients With Advanced Hematologic and Solid Tumor Malignancies
United States3 participantsStarted 2023-01-25
Plain-language summary
The purpose of the study is to find out if an investigational drug called PRGN-3007 UltraCAR-T cells (PRGN-3007 T cells) can help people with ROR1-positive hematologic chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), acute lymphoblastic leukemia (ALL), diffuse large B-cell lymphoma (DLBCL) and solid tumor triple negative breast cancer (TNBC) malignancies.
Who can participate
Age range18 Years
SexALL
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Key Inclusion Criteria:
* Age 18 years and older
* Eastern Cooperative Oncology Group (ECOG) score of 0 or 1; or Karnofsky Performance Status (KPS) of ≥ 70%.
* Life expectancy ≥ 12 weeks from the time of enrollment
* Must have adequate organ function, as defined in protocol.
* Patients must be at least 2 weeks or 5 half-lives (whichever is shorter)post systemic steroids prior to enrollment except as premedication for contrast allergy
* Negative serum pregnancy test for women of child bearing potential (WOCBP). Fertile male and female patients must be willing to use a contraceptive method before, during, and for at least 12 months after the last T cell infusion
* All patients must have the ability to understand and willingness to sign a written informed consent form (ICF).
Exclusion Criteria:
* Patient has received any of the following treatments prior to leukapheresis: cytotoxic chemotherapy or radiation therapy within 14 days; an antineoplastic monoclonal antibody within prior 4 weeks; prior targeted therapy 14 days or 5 half-lives from the last dose whichever is shorter; or prior systemic inhibitory/stimulatory immune checkpoint molecule therapy (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists) within 3 half-lives; or has not recovered from (i.e., ≤ grade 1) adverse event (AE) caused by prior treatment. Exceptions include hydroxyurea, single agent vincristine or steroids for uncontrolled ALL.
* Burkitt lymphoma is excluded.
* Prior a…
What they're measuring
1
Maximum Tolerated Dose (MTD) of PRGN-3007 (Group A)
Timeframe: Up to 12 months
2
Maximum Tolerated Dose (MTD) of PRGN-3007 (Group B)
Timeframe: Up to 12 months
Trial details
NCT IDNCT05694364
SponsorH. Lee Moffitt Cancer Center and Research Institute