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Experimental cell therapy takes on Hard-to-Treat blood cancers
NCT ID NCT04155710
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tested a new cell therapy called IOV-2001 in 7 patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that had stopped responding to standard drugs. The therapy uses a patient's own immune cells, which are collected, processed, and then infused back along with interleukin-2 to boost their activity. The main goals were to find the right dose and check for safety and any signs of tumor shrinkage.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- IOV-2001 (a cell therapy made from the patient's own immune cells) followed by interleukin-2 (IL-2)
- What this could lead to
- If successful, this could offer a new treatment option for patients with CLL or SLL that has stopped responding to standard drugs like ibrutinib.
- What could go wrong
- This was a very early, small trial (only 7 people) with no published results yet. Cell therapies can cause serious side effects, and it is unclear if this approach will work better than existing treatments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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7 people
The number who actually took part.
- Started
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Feb 2020
- Finished
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Dec 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients with CLL or SLL with radiographically measurable disease * Cohort 2 only: patients with progressed or progressing CLL/SLL on ibrutinib or acalabrutinib with del 17p and/or TP53 mutated * Cohort 3 only: patients with progressed or progressing CLL/SLL on ibrutinib or acalabrutinib without del 17p and/or TP53 mutated 2. Patients must have documented progression or be progressing on ibrutinib or acalabrutinib, as indicated by the presence of known BTK resistance mutation 3. Patients must have received at least 1 prior regimen (only for patients without del 17p and/or TP53 mutated) and currently be on ibrutinib or acalabrutinib. For patients on combination therapy as the last line of therapy prior study entry, progression to any of the individual components of the combination therapy, rather than to the combination regimen, is required. * For Cohort 2: The single prior regimen can be ibrutinib or acalabrutinib (ie, patients are eligible while progressing on their first line of therapy) * For Cohort 3: Patients must have progressed on at least 1 additional line of therapy in addition to ibrutinib or acalabrutinib 4. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of ≥ 3 months. 5. Patients must have adequate bone marrow function to receive NMA-LD 6. Pulmonary function assessed by spirometry demonstrating FEV1 \> 50% predicted normal 7. Cardiac function demonstrating left ventricular ejection fraction (LVEF) \> 45% 8. Patients of childbearing potential or their partners of childbearing potential must be willing to practice an approved method of birth control during treatment and for 12 months after receiving the last protocol-related therapy. Exclusion Criteria: 1. Patients who have received an organ allograft or prior cell transfer therapy within 20 years. 2. Patients with known or suspected transformed disease (ie, Richter's Transformation). 3. Patients who received treatment with any systemic chemotherapy, immunotherapy, targeted small molecule inhibitors, or other biologic agents within 30 days or 5 half-lives, whichever is shorter, of IOV-2001 infusion with the exception of ibrutinib or acalabrutinib 4. Patients with known involvement of central nervous system (CNS) by lymphoma or leukemia 5. Patients who are on chronic systemic steroid therapy \>5 mg/day prednisone equivalent for any reason 6. Patients who have active systemic infections requiring systemic ABX, autoimmune anemia or thrombocytopenia, coagulation disorders, or other active major medical illnesses of the cardiovascular, respiratory, or immune system. 7. Patients who are seropositive for any of the following: * Human immunodeficiency virus (HIV)-1 or HIV-2 antibodies * Hepatitis B antigen (HbsAg) or anti-hepatitis B core total antibodies (anti-HbcAb), or hepatitis C antibody (HCVAb) 8. Patients with active and chronic fungal, bacterial, or viral infection requiring IV treatment 9. Patients who require treatment for anti-coagulation with a vitamin K antagonist (warfarin) 10. Patients who have received a live or attenuated vaccine within 28 days of beginning the preparative NMA-LD regimen 11. Patients who are pregnant or breastfeeding
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Allegheny Health
Pittsburgh, Pennsylvania, 15224, United States
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Baptist Cancer Center
Memphis, Tennessee, 38120, United States
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Duke University
Durham, North Carolina, 27710, United States
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Moffitt Cancer Center
Tampa, Florida, 33612, United States
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Ohio State University
Columbus, Ohio, 43210, United States
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University of Cincinnati Medical Center
Cincinnati, Ohio, 45219, United States
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University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two-Drug combo aims to push CLL into deep remission
- Can a new BTK inhibitor outsmart resistance in CLL?
- Can a new pill outsmart Drug-Resistant leukemia?
- Can engineered immune cells beat tough B-Cell cancers?
- Can a targeted drug outperform chemo for a common blood cancer?
- Can a triple drug combo outsmart High-Risk CLL?