Triple therapy takes on aggressive blood cancer
NCT ID NCT05672173
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial is testing whether adding a personalized cell therapy (liso-cel) to two existing drugs (nivolumab and ibrutinib) can help people with Richter's transformation, a rare and aggressive blood cancer. The study plans to enroll 9 participants and will measure how many achieve a complete response. It is still early, so the main goals are to check safety and see if the combination is promising enough for larger studies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lisocabtagene maraleucel (a CAR T-cell therapy made from the patient's own immune cells), nivolumab (an immunotherapy drug), and ibrutinib (a targeted cancer pill)
- What this could lead to
- If this combination works, it could offer a new treatment option for people with Richter's transformation, a very aggressive blood cancer.
- What could go wrong
- This is a very small, early-phase trial with only 9 participants, so results may not apply to everyone. The combination therapy also carries risks of serious side effects, including immune system overreactions.
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
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
9 people
The number who actually took part.
- Started
-
Jun 2023
- Expected to finish
-
Sep 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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: * Documented informed consent of the participant * Agreement for confirmatory pre-treatment tumor biopsy * If a patient does not have an easily accessible lymph node to biopsy without excessive risk in the opinion of the investigator, archival biopsy material reviewed by a hematopathologist at the enrolling site for study eligibility and baseline correlatives may be acceptable with approval from the Study principal investigator (PI) * Age: \>= 18 years * Eastern cooperative oncology group (ECOG) \<= 2 * Histologically confirmed Richter's Transformation (RT) * Relapsed / refractory following \>=2 prior lines of systemic therapy; OR refractory to first-line chemoimmunotherapy; OR relapsed within 12 months of first line chemoimmunotherapy; OR relapsed after first line of chemoimmunotherapy and not eligible for hematopoietic stem cell transplantation due to comorbidities or age * Eligible to receive liso-cel and ibrutinib per package inserts * Fully recovered from the acute toxic effects (except alopecia) to \<= Grade 1 to prior anti-cancer therapy * Absolute neutrophil count (ANC) \>= 750/mm\^3 unless there is bone marrow involvement * Platelets \>= 75,000/mm\^3 unless there is bone marrow involvement * Total bilirubin =\< 1.5 X ULN (unless has Gilbert's disease) * Aspartate aminotransferase (AST) =\< 2.5 x ULN * Alanine aminotransferase (ALT) =\< 2.5 x ULN * Creatinine clearance of \>= 30 mL/min per 24 hour urine test or the Cockcroft-Gault formula * International Normalized Ratio (INR) OR Prothrombin (PT) =\< 1.5 x ULN * Activated Partial Thromboplastin Time (aPTT) =\< 1.5 x ULN * Left ventricular ejection fraction (LVEF) \>= 40% * Note: To be performed within 28 days prior to Day 1 of protocol therapy. * Seronegative for HCV\*, active HBV (Surface Antigen Negative), and syphilis (RPR) * If positive, Hepatitis C RNA quantitation must be performed OR * If seropositive for HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable * Meets other institutional and federal requirements for infectious disease titer requirements * Note: Infectious disease testing to be performed within 28 days prior to Day 1 of protocol therapy * Women of childbearing potential (WOCBP): negative urine or serum pregnancy test * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required * Agreement by females and males of childbearing potential\* to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 5 months after the last dose of protocol therapy * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only) Exclusion Criteria: * Subjects who previously received PD1 or PD-L1 inhibitor therapy * Autologous stem cell transplant within 3 months prior to Day 1 of protocol therapy * Allogeneic stem cell transplant within 3 months prior to Day 1 of protocol therapy and no active graft versus host disease (GVHD) or need for immunosuppressants * Chemotherapy, radiation therapy, immunotherapy within 14 days prior to Day 1 of protocol therapy * Strong CYP3A inducers within 14 days prior to Day 1 of protocol therapy * Warfarin within 5 days prior to Day 1 of protocol therapy * Current requirement for oxygen supplementation * Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled steroids is not exclusionary. Physiologic replacement of steroids (prednisone =\< 7.5 mg /day or equivalent) is allowed throughout the study. Use of "bridging" steroids, to control disease, after leukapheresis and until 3 days prior to CAR T cell infusion, is allowed * Subjects with lymphoma only involving the central nervous system * Class III/IV cardiovascular disability according to the New York Heart Association (NYHA) Classification * Subjects with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of screening * Subjects with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system, including seizure disorder * Subjects with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent * Known bleeding disorders (e.g., von Willebrand's disease) or hemophilia * History of stroke or intracranial hemorrhage within 6 months prior to screening * History of other malignancies, except for malignancy surgically resected (or treated with other modalities) with curative intent, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; non-muscle invasive bladder cancer; malignancy treated with curative intent with no known active disease present for \>= 3 years * Clinically significant uncontrolled illness * Active infection requiring antibiotics * Known history of immunodeficiency virus (HIV) * Females only: Pregnant or breastfeeding * Subjects with an active, known or suspected autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis) not requiring systemic treatment, well controlled asthma and/or mild allergic rhinitis (seasonal allergies) are eligible * Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Recurrent transformed chronic lymphocytic leukemia are added.
Genom att skicka in godkänner du våra Användarvillkor
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
-
City of Hope Medical Center
Duarte, California, 91010, United States
-
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a targeted drug boost the fight against an aggressive blood cancer?
- Combination therapy targets aggressive lymphoma in CLL patients
- Immunotherapy combo shows promise for Tough-to-Treat blood cancers
- Engineered immune cells take on tough blood cancers in early trial
- Triple-Target CAR T-Cells offer new hope for tough blood cancers
- New combo therapy aims to keep lymphoma at bay after transplant