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CAR T-cell Therapy
UltraCAR-T Therapy for Leukemia and Breast Cancer
Phase 1
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am mostly active and can care for myself.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD) of PRGN-3007 (Group A)
Maximum Tolerated Dose (MTD) of PRGN-3007 (Group B)
Secondary outcome measures
Disease Control Rate
Overall Response Rate
Trial Design
4Treatment groups
Experimental Treatment
Group I: Phase 1b Dose Expansion (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 at the dose level determined to be the Maximum Tolerated Dose (MTD) in the dose escalation portion of the study.
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 3
~1100
Cyclophosphamide
1995
Completed Phase 3
~3770
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
543 Previous Clinical Trials
135,407 Total Patients Enrolled
Precigen, IncIndustry Sponsor
5 Previous Clinical Trials
255 Total Patients Enrolled
Javier Pinilla-Ibarz, MD, PhDPrincipal InvestigatorMoffitt Cancer Center
1 Previous Clinical Trials
51 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot receive certain chemotherapy due to health risks.You are expected to live for at least 12 weeks from the time you join the study.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.I am mostly active and can care for myself.I have not received a live vaccine in the last 4 weeks.I am 18 years old or older.I need to take warfarin.I have an autoimmune disease that hasn't caused organ damage, or it's related to my current illness.I have not had certain cancer treatments or recovered from their side effects recently.My lung function is good, based on recent tests.I don't have serious ongoing infections, heart, lung problems, or mental health issues that would stop me from following the study rules.I do not have Burkitt lymphoma.I have not had any other cancer besides this one in the last year.I had skin cancer or early-stage cancer treated successfully and am in remission.I have a genetic condition linked to bone marrow failure.I have a history of brain or nerve disorders.I have recovered from any major infections or recent surgeries.I have HIV or active hepatitis B/C, or had hepatitis with now undetectable viral load.I don't have active brain cancer or untreated brain metastases, but I may have had treated and stable brain metastases over a month ago.I have had a blood clot in my leg or lung in the last 6 months.I am not pregnant and willing to use birth control during and after treatment.I stopped taking systemic steroids at least 2 weeks ago or 5 half-lives ago, whichever is shorter.My organs are functioning well.Side effects from my previous treatments are mild or gone, except for hair loss.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1b Dose Expansion (Group B)
- Group 2: Phase 1b Dose Expansion (Group A)
- Group 3: Phase 1 Dose Escalation (Group B)
- Group 4: Phase 1 Dose Escalation (Group A)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is this medical experiment involving participants?
"Affirmative. Data available on clinicaltrials.gov demonstrates that this medical trial, which was originally published on December 1st 2023, is currently recruiting patients. In total, 88 participants are needed across a single site of research."
Answered by AI
What risks do participants in Phase 1 Dose Escalation (Group A) face?
"Due to the exploratory nature of Phase 1 Dose Escalation (Group A), there is limited clinical evidence for both safety and efficacy. Consequently, this intervention has been rated as a '1' in terms of safety by Power's team."
Answered by AI
Is this trial currently enrolling participants?
"Data on clinicaltrials.gov affirms that this clinical trial is still recruiting participants, with the first posting and last update both occurring on January 12th, 2023."
Answered by AI
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