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

A Single-Center, Single-Arm, Phase 1 Pilot Study of Pomalidomide Following CD19-Directed Chimeric Antigen Receptor T-Cell Therapy in Relapsed/Refractory CD19+ B-Cell Leukemias and Lymphomas

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.

Study Overview

• Status: Recruiting
• Conditions: Refractory B-Cell Non-Hodgkin Lymphoma; Recurrent B-Cell Non-Hodgkin Lymphoma; Recurrent B Acute Lymphoblastic Leukemia; Refractory B Acute Lymphoblastic Leukemia
• Intervention / Treatment: Procedure: Biospecimen Collection; Drug: Pomalidomide

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jennifer E Agrusa, MD; Phone Number: 734-232-9335; Email: jagrusa@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan Rogel Cancer Center
      • Principal Investigator: Jennifer E. Agrusa
      • Contact: Jennifer E. Agrusa; Phone Number: 734-232-9335; Email: jagrusa@med.umich.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 or Lansky 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

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: Biospecimen Collection; Undergo collection of blood samples; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Drug: Pomalidomide; Given PO; Other Names: Pomalyst; Imnovid; 4-Aminothalidomide; Actimid; CC-4047; CC4047; CC 4047

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	Will assess the safety and tolerability of pomalidomide following CD19 chimeric antigen receptor T-cell (CD19CART) therapy for recurrent/refractory B-cell leukemia/lymphoma. Hematologic and non-hematologic toxicity within the first 56 days following the initiation of pomalidomide will be monitored. All observed toxicities, including dose-limiting toxicity will be summarized in terms of type (organ affected or laboratory determination), severity (by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0), duration, and reversibility or outcome. Tables will be created to summarize toxicities.	Within first 56 days following pomalidomide initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CD19CART transgene expression	Anti-CD19 (FMC63) CAR-T qPCR assay	At days 0, 7, 14, 28, and 56
CD19CART transgene expression	A Spaghetti plot of individual transgene expression levels will be presented through 1-year post-pomalidomide initiation, with a population average superimposed on the plot.	At 1 year
Overall survival	Kaplan-Meier estimates with confidence intervals will be presented and proportions will be accompanied by 95% confidence intervals. Subject to available event rates for model convergence, a Cox proportional hazards model with transgene expression as a continuous predictor will be used to explore potential association with overall survival.	Up to 1 year
Event-free survival (EFS)	1-year EFS estimates with confidence intervals will be presented and proportions will be accompanied by 95% confidence intervals. Events will be defined as disease relapse, progression, or death due to any cause.	Up to 1 year
Duration of response	From the time of first response to time of relapse, disease progression, or death	Up to 1 year
Lymphocyte profiles	Immunophenotyping of lymphocyte profiles will be plotted via a Spaghetti plot with a heat map color scheme to correlate T-cell differentiation profiles with CD19CART transgene expression at the concurrent time points.	At baseline and days 7, 14, 28, and 56
Serum cytokine and chemokine levels	Will be plotted via a Spaghetti plot with a heat map color scheme to correlate cytokine/chemokine levels with CD19CART transgene expression at the concurrent time points.	At baseline and days 7, 14, 28, and 56

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center
• Investigators: Principal Investigator: Jennifer E Agrusa, MD, University of Michigan Rogel Cancer Center

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: April 9, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Infections; Virus Diseases; Neoplasms by Histologic Type; DNA Virus Infections; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Epstein-Barr Virus Infections; Herpesviridae Infections; Tumor Virus Infections; Hemic and Lymphatic Diseases; Lymphoma, B-Cell; Burkitt Lymphoma; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; pomalidomide
• Other Study ID Numbers: UMCC 2025.011; NCI-2026-00885 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); HUM00273237 (Other Identifier: University of Michigan Rogel Cancer Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual subject data will not be provided; however, our cumulative findings based upon response and survival for the entire population will be provided.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes