Can a pill make CAR T-Cell therapy last longer?
NCT ID NCT07532525
First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 2 times
Summary
This early-phase trial tests whether the drug pomalidomide can improve the effects of CAR T-cell therapy in people with B-cell leukemias or lymphomas that have returned or not responded to treatment. The study will enroll 12 adults who have already received CAR T-cell therapy. Researchers want to see if pomalidomide is safe and whether it helps CAR T-cells stay active longer in the body.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pomalidomide
- What this could lead to
- If it works, this could point toward a way to make CAR T-cell therapy more effective and longer-lasting for people with hard-to-treat B-cell cancers.
- What could go wrong
- This is a very early, small phase 1 trial with only 12 participants. It is primarily testing safety, not yet whether the combination actually works better. Pomalidomide can cause side effects like low blood counts and blood clots.
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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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- 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: * Subject must have had a histologically or cytologically confirmed R/R CD19+ B-cell leukemia or lymphoma and have received a commercially available CAR-T product approved to treat R/R CD19+ Bcell leukemias and lymphomas. * Subject must be 28 - 56 days post infusion of CD19CART product at time of enrollment. * \>= 18 years in age at time of enrollment * Subject is able to swallow pills/tablets * Karnofsky performance score of \>= 50% * Absolute neutrophil count (ANC) \>= 750/mm\^3 (granulocyte colony stimulating factor allowed) * Platelets \>= 50,000/mm\^3 (transfusion independent for \>= 7 days, defined as not receiving platelet transfusions for at least 7 days prior to enrollment, unless due to marrow involvement from primary malignancy \[thrombopoietin (TPO) mimetics allowed\]) * Total bilirubin =\< 1.5 x upper limit of normal (ULN) per institution * Alanine aminotransferase (ALT \[serum glutamate pyruvate transaminase (SGPT)\]) =\< 3 x institutional ULN per institution * Serum albumin \>= 2.0 g/dL * Creatinine clearance (Cockcroft-Gault equation) \>= 30 mL/min/1.73 m\^2 * Sexually active females capable of becoming pregnant and males must agree to participate in the pomalidomide Risk Evaluation and Mitigation Strategy (REMS) program * Patients must agree not to donate blood during treatment with pomalidomide and for 4 weeks following discontinuation of the drug because the blood might be given to a pregnant female patient whose fetus must not be exposed to pomalidomide * Co-Enrollment: Willingness to consent/ co-enroll on BMT long term follow up study, HUM00043287 (UMCC2001-0234) Exclusion Criteria: * Patients with known progressive or refractory disease. * The following transplant or CAR T-related events are excluded: * Active grade \>= 2 acute or chronic graft versus host disease (GVHD) * Active cytokine release syndrome (CRS) grade \>= 2 * Active immune effector cell associated neurotoxicity (ICANS) grade \>= 2 * Subject receiving \>= 0.25 mg/kg/day of methylprednisolone equivalent. Subject being treated with medications with a known major drug interaction to pomalidomide. Specifically, patients receiving CYP1A2 inhibitors, such as ciprofloxacin, omeprazole, cimetidine, estrogen, and fluvoxamine. * Patient who smokes cigarettes. * Subject must not have initiated or received intervening therapy for a primary or secondary malignancy within 28 days of study enrollment, including, a) myelosuppressive chemotherapy, b) biologic anti-neoplastic agents (e.g., ruxolitinib, imatinib, dasatinib…), or checkpoint inhibitors (e.g., pembrolizumab). The use of cytokine inhibition for management of CRS/ICANS is allowed within the prior 28 days * Receipt of radiation therapy (XRT) (focal or large field, including cranial or cranial-spinal) within 28 days prior to enrollment * Stem cell transplant or rescue following most recent CD19CART therapy * History of allergic reactions to pomalidomide or any of the excipients and any similar compounds * Intercurrent illness or conditions: * Patients with uncontrolled infections. In addition, patients with any documented bacteremia, fungemia, or new onset viremia that requires antimicrobial therapy within 72 hours prior to enrollment. Empiric antimicrobials are allowed * Active grade \>= 4 gastrointestinal, hepatic, pulmonary, renal, cardiac toxicity by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 criteria. Patients requiring dialysis are excluded * Patients with concomitant genetic syndromes associated with bone marrow failure states: such as patients with Fanconi anemia, severe congenital neutropenia, Schwachman syndrome or any other known bone marrow failure syndrome. Patients with Down syndrome are not excluded * History of known prior arterial thromboembolism, venous thromboembolism, pulmonary embolism, cardiovascular accidents, or myocardial infarctions within 3 months prior to enrollment * Pregnant women are excluded from this study. Women should discontinue breastfeeding during treatment and for at least 4 weeks after discontinuation of study drug * HIV positivity within 8 weeks of screening on polymerase chain reaction (PCR) based assay
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Michigan Rogel Cancer Center
RECRUITINGAnn Arbor, Michigan, 48109, United States
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