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CAR T-cell Therapy

UltraCAR-T Therapy for Leukemia and Breast Cancer

Phase 1

Waitlist Available

Led By Javier Pinilla-Ibarz, MD, PhD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) score of 0 or 1; or Karnofsky Performance Status (KPS) of ≥ 70%

Age 18 years and older

Must not have

Patients who have contraindication to the lymphodepletion chemotherapy regimen

Prior allogeneic hematopoietic stem cell transplant (HSCT) or donor lymphocyte infusion within 6 months prior to enrollment, current acute graft versus host disease grade 2-4 by Glucksberg criteria or severity B-D by by International Bone Marrow Transplant Registry (IBMTR) index or history of severe (grade 3-4) acute graft versus host disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug to treat CLL, MCL, ALL, DLBCL, and TNBC.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as fever and fatigue; organ inflammation; complications from low blood cell counts like infections or bleeding; nausea from chemotherapy; allergic reactions during infusion of the CAR-T cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am mostly active and can care for myself.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot receive certain chemotherapy due to health risks.

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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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I need to take warfarin.

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My lung function is good, based on recent tests.

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I don't have serious ongoing infections, heart, lung problems, or mental health issues that would stop me from following the study rules.

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I do not have Burkitt lymphoma.

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I have not had any other cancer besides this one in the last year.

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I have a genetic condition linked to bone marrow failure.

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I have a history of brain or nerve disorders.

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I have had a blood clot in my leg or lung in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum Tolerated Dose (MTD) of PRGN-3007 (Group A)

Maximum Tolerated Dose (MTD) of PRGN-3007 (Group B)

Secondary study objectives

Disease Control Rate

Overall Response Rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 4

~1830

Cyclophosphamide

2010

Completed Phase 4

~2310