Recruiting

Phase 1

Pomalidomide with CD19CARTPomalidomide After CAR T-cell Therapy for the Treatment of Relapsed or Refractory CD19+ B-cell Leukemia or Lymphoma

Sponsor:

University of Michigan Rogel Cancer Center

Code:

NCT07532525

Conditions

Recurrent B Acute Lymphoblastic Leukemia

Recurrent B-Cell Non-Hodgkin Lymphoma

Refractory B Acute Lymphoblastic Leukemia

Refractory B-Cell Non-Hodgkin Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Pomalidomide

Study Details

Brief summary:

This phase I trial tests the safety and effectiveness of pomalidomide after CD19 chimeric antigen receptor T-cell (CD19CART) therapy for the treatment of patients with CD19+ B-cell leukemias or lymphomas that have come back after a period of improvement (relapsed) or do not respond to treatment (refractory). Chimeric antigen receptor (CAR) T-cell therapy is a type of treatment in which a patient's T-cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells and are then re-infused into the patient. Following CAR T-cell infusion, CAR T-cells must expand and persist in the blood stream in order to most effectively treat leukemia/lymphoma. Pomalidomide stops the growth of blood vessels, stimulates the immune system, and may kill cancer cells. Research has shown that drugs like pomalidomide can modify the immune system and increase the number or improve the function of CAR T-cells in the blood. Pomalidomide may enhance the treatment effects of CAR T-cell therapy in patients who have received CD19CART therapy for relapsed or refractory CD19+ B-cell leukemia or lymphoma.

Conditions

Recurrent B Acute Lymphoblastic Leukemia

Recurrent B-Cell Non-Hodgkin Lymphoma

Refractory B Acute Lymphoblastic Leukemia

Refractory B-Cell Non-Hodgkin Lymphoma

Study ID

NCT07532525

Start date

Sep 1, 2026

Status verified date

Jul, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (pomalidomide)

Patients receive pomalidomide PO QD for 10 doses in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples on study.

Interventions

Biospecimen Collection

Undergo collection of blood samples

Pomalidomide

Given PO

Primary outcome measure

Incidence of adverse events [ Time Frame: Within first 56 days following pomalidomide initiation ]

Central Contacts and Locations

Central contacts

Jennifer E Agrusa, MD

734-232-9335 jagrusa@med.umich.edu

Locations

University of Michigan Rogel Cancer Center

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Jennifer E. Agrusa

734-232-9335 jagrusa@med.umich.edu

Principal Investigator:

Jennifer E. Agrusa

More Information

Sponsor

University of Michigan Rogel Cancer Center

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Michigan Rogel Cancer Center on 2026-07-16.