UltraCAR-T Therapy for Leukemia and Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen byJavier Pinilla-Ibarz, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Adults with certain blood cancers or solid tumors, like leukemia and breast cancer, who are in fairly good health (ECOG score of 0 or 1) and expected to live at least 12 weeks can join. They must not be pregnant, agree to use birth control, understand the study's consent form, have no serious lung/cardiac issues or infections, no recent major surgeries or other cancer treatments within specific time frames.

Inclusion Criteria

You are expected to live for at least 12 weeks from the time you join the study.

I am mostly active and can care for myself.

I am 18 years old or older.

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Exclusion Criteria

I cannot receive certain chemotherapy due to health risks.

I do not have an immune deficiency, active autoimmune disease needing strong medication, or recent immunosuppressive therapy.

I had a stem cell transplant or donor lymphocyte infusion less than 6 months ago, or I currently have severe graft versus host disease.

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Treatment Details

Interventions

PRGN-3007 (CAR T-cell Therapy)

Trial OverviewThe trial is testing PRGN-3007 UltraCAR-T cells combined with Fludarabine and Cyclophosphamide chemotherapy to see if they're effective against ROR1-positive malignancies including various leukemias, lymphomas, and triple negative breast cancer.

Participant Groups

4Treatment groups

Experimental Treatment

Group I: Phase 1b Dose Expansion (Group B)Experimental Treatment2 Interventions

Group II: Phase 1b Dose Expansion (Group A)Experimental Treatment3 Interventions

Participants from group A (hematologic malignancies) will undergo leukapheresis followed by lymphodepletion and infusion of PRGN-3007. Lymphodepletion will include 3 days of treatment with fludarabine (30 mg/m\^2) and cyclophosphamide (500 mg/m\^2) prior to study day 0. Participants will then receive PRGN-3007 at the dose level determined to be the Maximum Tolerated Dose (MTD) in the dose escalation portion of the study.

Group III: Phase 1 Dose Escalation (Group B)Experimental Treatment2 Interventions

Participants from group B (solid tumors) will undergo leukapheresis followed by lymphodepletion and infusion of PRGN-3007. Lymphodepletion will include 2 days of cyclophosphamide (500 mg/m\^2) prior to study day 0. Participants will then receive PRGN-3007 in 3 dose levels beginning at Dose Level 1, using a standard 3+3 escalation design to determine Maximum Tolerated Dose (MTD). The target maximum doses infused at each dose level is: Dose Level 1: 1x10\^6 cells/kg Dose Level 2: 3x10\^6 cells/kg Dose Level 3: 1x10\^7 cells/kg

Group IV: Phase 1 Dose Escalation (Group A)Experimental Treatment3 Interventions

Participants from group A (hematologic malignancies) will undergo leukapheresis followed by lymphodepletion and infusion of PRGN-3007. Lymphodepletion will include 3 days of treatment with fludarabine (30 mg/m\^2) and cyclophosphamide (500 mg/m\^2) prior to study day 0. Participants will then receive PRGN-3007 in 3 dose levels beginning at Dose Level 1, using a standard 3+3 escalation design to determine Maximum Tolerated Dose (MTD). The target maximum doses infused at each dose level is: Dose Level 1: 1x10\^6 cells/kg Dose Level 2: 3x10\^6 cells/kg Dose Level 3: 1x10\^7 cells/kg