3 Participants Needed

UltraCAR-T Therapy for Leukemia and Breast Cancer

Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

The trial requires that you stop certain medications before joining. You must be off cytotoxic chemotherapy, radiation therapy, and some other treatments for a specific time before starting the trial. Check with the trial team to see if your current medications are affected.

What makes the UltraCAR-T treatment PRGN-3007 unique for leukemia and breast cancer?

UltraCAR-T therapy, like PRGN-3007, is unique because it involves genetically modifying T cells to specifically target cancer cells, offering a personalized approach that can potentially lead to complete remission in cases where traditional treatments have failed. This therapy is part of a new wave of immunotherapies that use chimeric antigen receptors (CARs) to enhance the body's immune response against cancer.12345

What data supports the effectiveness of the treatment PRGN-3007 in the UltraCAR-T Therapy for Leukemia and Breast Cancer?

CAR T-cell therapy, which involves modifying T cells to target cancer cells, has shown promising results in treating blood cancers like B-cell acute lymphoblastic leukemia, with high remission rates. This suggests potential effectiveness for similar therapies like PRGN-3007 in treating leukemia and possibly breast cancer.13678

Who Is on the Research Team?

JP

Javier Pinilla-Ibarz, MD, PhD

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

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 not pregnant and willing to use birth control during and after treatment.
See 3 more

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.
See 18 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Leukapheresis and Lymphodepletion

Participants undergo leukapheresis followed by lymphodepletion with fludarabine and cyclophosphamide

3-5 days

Dose Escalation

Participants receive PRGN-3007 in 3 dose levels to determine Maximum Tolerated Dose (MTD) using a 3+3 escalation design

Up to 12 months

Dose Expansion

Participants receive PRGN-3007 at the dose level determined to be the Maximum Tolerated Dose (MTD)

Up to 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • PRGN-3007
Trial Overview 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.
How Is the Trial Designed?
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
Group III: Phase 1 Dose Escalation (Group B)Experimental Treatment2 Interventions
Group IV: Phase 1 Dose Escalation (Group A)Experimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials
576
Recruited
145,000+

Precigen, Inc

Industry Sponsor

Trials
7
Recruited
300+

Published Research Related to This Trial

CAR T-cell immunotherapy, which involves genetically modifying T cells to target cancer cells, has shown promising results, especially in treating B-cell malignancies with several patients achieving complete and durable responses.
Current research is expanding CAR T-cell therapy to solid tumors, specifically targeting members of the ErbB family, indicating a potential for broader applications in cancer treatment.
ErbB-targeted CAR T-cell immunotherapy of cancer.Whilding, LM., Maher, J.[2022]
CAR T cell therapy targeting CD19 has shown remarkable efficacy, achieving complete remission in up to 90% of patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL), compared to a 30% response rate with traditional chemotherapy.
The therapy involves genetically modifying T cells to express a chimeric antigen receptor, allowing them to effectively target and eliminate cancer cells, although it is important to note that there are unique toxicities associated with this treatment that require careful management.
CD19-Targeted CAR T cells as novel cancer immunotherapy for relapsed or refractory B-cell acute lymphoblastic leukemia.Davila, ML., Brentjens, RJ.[2023]
In a phase-1/2 trial involving 13 adult patients with refractory acute lymphoblastic leukemia, third-generation CAR T cells (CARTs) demonstrated promising efficacy, with 80% of evaluable patients achieving complete remission, including 50% with no detectable residual disease.
The treatment was associated with remarkably low toxicity, as none of the patients experienced severe side effects like neurotoxicity or high-grade cytokine release syndrome, indicating a favorable safety profile for this innovative therapy.
Treatment of adult ALL patients with third-generation CD19-directed CAR T cells: results of a pivotal trial.Schubert, ML., Schmitt, A., Hückelhoven-Krauss, A., et al.[2023]

Citations

Phase I Trial of Anti-PSMA Designer CAR-T Cells in Prostate Cancer: Possible Role for Interacting Interleukin 2-T Cell Pharmacodynamics as a Determinant of Clinical Response. [2022]
Chimeric antigen receptor T cell therapy in oncology - Pipeline at a glance: Analysis of the ClinicalTrials.gov database. [2022]
ErbB-targeted CAR T-cell immunotherapy of cancer. [2022]
CD19-Targeted CAR T cells as novel cancer immunotherapy for relapsed or refractory B-cell acute lymphoblastic leukemia. [2023]
Treatment of adult ALL patients with third-generation CD19-directed CAR T cells: results of a pivotal trial. [2023]
Evaluation of switch-mediated costimulation in trans on universal CAR-T cells (UniCAR) targeting CD123-positive AML. [2021]
Chimeric antigen receptor T cells (CAR-T) for the treatment of T-cell malignancies. [2020]
CAR-T therapy for leukemia: progress and challenges. [2018]
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