Pomalidomide After CAR T-cell Therapy for B-Cell Lymphoma

Overseen By Jennifer E Agrusa, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Michigan Rogel Cancer Center

Must not be taking: CYP1A2 inhibitors

Disqualifiers: Progressive disease, Smoking, Uncontrolled infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 7

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if pomalidomide can enhance the effectiveness of previous CAR T-cell therapy for individuals with certain blood cancers, specifically CD19+ B-cell leukemia or lymphoma, that have relapsed or are difficult to treat. CAR T-cell therapy modifies a patient's immune cells to target cancer, and pomalidomide may boost the performance of these modified cells. This trial suits those who have undergone CAR T-cell therapy for relapsed or refractory CD19+ B-cell leukemia or lymphoma, are at least 28 days post-infusion, and can swallow pills. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering a chance to be among the first to receive this new treatment.

Is there any evidence suggesting that pomalidomide is likely to be safe for humans?

Research has shown that pomalidomide is generally well-tolerated in patients with blood cancers. One study found that about 23% of patients experienced serious side effects, such as low levels of white blood cells (neutropenia), platelets (thrombocytopenia), and red blood cells (anemia). Despite these side effects, many still consider the treatment safe.

Pomalidomide may also enhance the effectiveness of CAR T-cells, potentially improving outcomes for those who have undergone CD19 CAR T-cell therapy for relapsed or hard-to-treat B-cell leukemia or lymphoma. Although researchers continue to study the treatment, these findings provide insight into its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for B-cell lymphoma?

Pomalidomide is unique because it offers a new approach for B-cell lymphoma patients who have already undergone CAR T-cell therapy. Unlike standard treatments like chemotherapy or radiation, pomalidomide works by modulating the immune system to enhance its ability to fight cancer cells. Additionally, it is taken orally, which can be more convenient and less invasive than traditional treatment methods. Researchers are excited about pomalidomide as it might provide a safer and potentially more effective option for patients who have limited choices after CAR T-cell therapy.

What evidence suggests that pomalidomide might be an effective treatment for B-cell lymphoma?

Research has shown that pomalidomide can enhance the effectiveness of CAR T-cell therapy, particularly for patients whose B-cell leukemia or lymphoma has recurred or hasn't responded to treatment. In this trial, participants will receive pomalidomide as part of the treatment regimen. Studies have found that pomalidomide helps CAR T-cells, which are crucial for fighting cancer, work better and increase in number. For instance, one study found that patients lived longer without their disease worsening and lived longer overall when pomalidomide was used. Another study showed up to a 100% response rate, meaning all patients experienced a significant reduction in cancer, when pomalidomide was combined with CAR T-cell therapy. This makes pomalidomide a promising option for improving treatment in these challenging cases. ^{2 3 5 6 7}

Who Is on the Research Team?

Jennifer E Agrusa, MD

Principal Investigator

University of Michigan Rogel Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

My platelet count is at least 50,000 and I haven't needed a transfusion in the past week.

I am 28 to 56 days past my CD19 CAR-T cell therapy infusion.

I am 18 years old or older.

Exclusion Criteria

I currently have moderate or severe cytokine release syndrome.

I have active moderate or severe graft versus host disease.

Patient who smokes cigarettes

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive pomalidomide orally once daily for 10 doses, with blood sample collection on study

2 weeks

Multiple visits for blood sample collection

Follow-up

Participants are monitored for safety and effectiveness, including adverse events and transgene expression

1 year

Regular visits at baseline and days 7, 14, 28, and 56

Long-term follow-up

Monitoring of event-free survival and overall survival up to 1 year

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Pomalidomide

How Is the Trial Designed?

Group I: Treatment (pomalidomide) Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials

303

Recruited

20,700+

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0006497125099677

Real-world efficacy and safety of pomalidomide-rituximab ...

Approximately 30% to 40% of patients still experience relapsed or refractory disease following initial treatment with this regimen. Extranodal ...

2.

ashpublications.org

ashpublications.org/blood/article/144/Supplement%201/6519/527469/Efficacy-and-Safety-of-Bendamustine-Pomalidomide

Efficacy and Safety of Bendamustine, Pomalidomide ...

Out of the 13 evaluable patients, the disease control rate (DCR) was 92.3%, with an overall response rate (ORR) of 11 cases (84.6%). Among them, ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10906647/

Pomalidomide improves the effectiveness of CAR-T treatment ...

Pomalidomide improves the effectiveness of CAR-T treatment in the relapsed and refractory multiple myeloma or B-cell leukemia/lymphoma with extramedullary ...

4.

ashpublications.org

ashpublications.org/blood/article/142/Supplement%201/6229/501216/Preliminary-Results-from-a-Phase-I-II-Study-of

Preliminary Results from a Phase I/II Study of Pomalidomide ...

Outcomes are particularly poor following immunochemotherapy failure or relapse within 12 months of induction. The addition of the ...

5.

clinical-lymphoma-myeloma-leukemia.com

clinical-lymphoma-myeloma-leukemia.com/article/S2152-2650(23)00228-8/fulltext

A Meta-Analysis of the Efficacy of Pomalidomide-Based ...

The data reported show pomalidomide-based combinations are effective in patients previously treated with lenalidomide and that pomalidomide-based treatment in ...

6.

ashpublications.org

ashpublications.org/blood/article/146/Supplement%201/7220/553901/Real-world-efficacy-and-safety-of-pomalidomide

Real-world efficacy and safety of pomalidomide-rituximab ...

The ORR was 92.9% (13/14), with a CR rate of 64.3% (n = 9), a PR rate of 28.5% (n = 4), and a progressive disease (PD) rate of 7.1% (n = 1).

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07523737

Study Details | NCT07523737 | Pomalidomide, Anti-PD-1 ...

Treatment options for R/R PCNSL are scarce, with low response rates, median survival of only 3-6 months, and 5-year survival below 5%. The blood ...