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Adoptive Cell Therapy

Autologous Immune Cell Therapy for Leukemia

Phase 1 & 2
Recruiting
Research Sponsored by Iovance Biotherapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have documented progression or be progressing on ibrutinib or acalabrutinib, as indicated by the presence of known BTK resistance mutation
Patients with CLL or SLL with radiographically measurable disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to two years
Awards & highlights

Study Summary

This trial is testing a new cancer treatment composed of patients' own immune cells. The treatment is for patients with CLL/SLL, a type of blood cancer, who have relapsed or are relapsing during treatment with ibrutinib or acalabrutinib.

Who is the study for?
This trial is for patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) who have measurable disease and are not responding well to treatments like ibrutinib or acalabrutinib. Participants should be in fairly good health, with a performance status of 0 or 1, meaning they're fully active or restricted in physically strenuous activity but can do light work. They must also have proper heart and lung function and agree to use birth control.Check my eligibility
What is being tested?
The study is testing IOV-2001, an Adoptive Cell Therapy using the patient's own Peripheral Blood Lymphocytes (PBL), combined with different doses of IL-2. It aims to see how well this treatment works for those whose CLL/SLL has relapsed during current therapies. The trial includes multiple cohorts based on genetic mutations and previous treatments.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system such as fever, chills, weakness, infection risk increase due to low blood cell counts; issues from high-dose IL-2 like low blood pressure, fluid buildup; plus general discomfort at infusion sites.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is getting worse despite taking ibrutinib or acalabrutinib.
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I have CLL or SLL that can be seen on scans.
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My CLL/SLL is getting worse despite treatment with ibrutinib or acalabrutinib, and I have specific genetic changes.
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My bone marrow functions well enough for treatment.
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I am currently on my first treatment with ibrutinib or acalabrutinib for my condition.
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I have tried at least one treatment after ibrutinib or acalabrutinib and my condition worsened.
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My cancer is getting worse despite taking ibrutinib or acalabrutinib.
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I can care for myself and doctors expect me to live at least 3 more months.
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My heart pumps blood effectively, with an ejection fraction over 45%.
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My heart pumps well, with an ejection fraction over 45%.
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My bone marrow functions well enough for treatment.
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I have CLL or SLL that can be seen on scans.
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My CLL/SLL is getting worse despite taking ibrutinib or acalabrutinib, and I don't have del 17p or TP53 mutations.
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I've had at least one treatment for my condition and am now on ibrutinib or acalabrutinib.
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I can care for myself and doctors expect me to live at least 3 more months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to one year or depending on when the recommended phase 2 dose is determined
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to one year or depending on when the recommended phase 2 dose is determined for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 2: Objective Response Rate
Phase I: RP2D (Recommended Phase 2 Dose)
Secondary outcome measures
Phase 1: Adverse Events
Phase 1: Disease Assessment
Phase 2: Disease Assessment (Separately for each cohort)

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment2 Interventions
CLL/SLL patients without del 17p who progressed or progressing on ibrutinib or acalabrutinib therapy. Patients will receive IOV-2001 + IL-2.
Group II: Cohort 2Experimental Treatment2 Interventions
CLL/SLL patients with del 17p who progressed or are progressing on ibrutinib or acalabrutinib therapy. Patients will receive IOV-2001 + IL-2.
Group III: Cohort 1bExperimental Treatment2 Interventions
CLL/SLL patients whose disease has relapsed or is relapsing post ibrutinib or acalabrutinib therapy. Patients will receive IOV-2001 + high dose IL-2.
Group IV: Cohort 1aExperimental Treatment2 Interventions
CLL/SLL patients whose disease has relapsed or is relapsing post ibrutinib or acalabrutinib therapy. Patients will receive IOV-2001 + low dose IL-2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IL-2
2007
Completed Phase 4
~1180

Find a Location

Who is running the clinical trial?

Iovance Biotherapeutics, Inc.Lead Sponsor
20 Previous Clinical Trials
1,626 Total Patients Enrolled
Iovance Biotherapeutics Medical MonitorStudy ChairIovance Biotherapeutics, Inc.
3 Previous Clinical Trials
420 Total Patients Enrolled

Media Library

IOV-2001 (Adoptive Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04155710 — Phase 1 & 2
Lymphoma Research Study Groups: Cohort 2, Cohort 1b, Cohort 1a, Cohort 3
Lymphoma Clinical Trial 2023: IOV-2001 Highlights & Side Effects. Trial Name: NCT04155710 — Phase 1 & 2
IOV-2001 (Adoptive Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04155710 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research mark a pioneering approach to the topic?

"Scientific research into IOV-2001 began in 2006, with the initial trial sponsored by Key Biologics, LLC. Following its successful completion involving 1230 participants, this pharmaceutical received Phase 2 drug approval. At present there are 24 concurrent trials taking place in 45 cities and 10 countries worldwide."

Answered by AI

Are there any precedents of IOV-2001 being trialled in past studies?

"Currently, 24 studies exploring IOV-2001 are in progress and none of them have reached Phase 3. A majority of the trials for this drug occur in Meldola, FC; but there also exist 70 other locations involved with research about it."

Answered by AI

What is the current scope of this clinical experiment?

"At present, there are 5 active research sites for this clinical trial. These include the Baptist Cancer Center in Memphis, Allegheny Health in Pittsburgh and Moffitt Cancer Centre in Tampa as well as an additional 5 locations."

Answered by AI

Is this research endeavor open to participation by octogenarians?

"This clinical trial has a fairly wide age range for participants with 18 being the minimum and 70 being the maximum."

Answered by AI

How many participants can partake in this clinical trial?

"The sponsor, Iovance Biotherapeutics Inc., has determined that 70 qualified participants are necessary for the success of this trial. The clinical centres participating include Baptist Cancer Center in Memphis, Tennessee and Allegheny Health in Pittsburgh, Pennsylvania."

Answered by AI

Is the research center still open to new participants?

"According to the clinicaltrials.gov record, this trial is actively recruiting participants after first posting on February 19th 2020 and last being modified on January 31st 2022."

Answered by AI

Am I a suitable candidate for this clinical trial?

"This medical trial will accept a cohort of 70 lymphoma patients, aged 18 to 70. To be considered eligible for the study, individuals must have documented resistance or progression in regards to ibrutinib or acalabrutinib (as specified by BTK resistant mutation), an ECOG performance status of 0-1 and estimated life expectancy greater than 3 months; Cohort 2 requires only one prior regimen with either ibrutinib or acalabrutinib while Cohort 3 necessitates at least 1 extra line of therapy beyond those two as well as adequate bone marrow function that can withstand NMA-"

Answered by AI
~0 spots leftby Apr 2024