42 Participants NeededMy employer runs this trial

CART-45 + CD45BE-HSPC for Lymphoma

AC
Overseen ByAbramson Cancer Center Clinical Trials Service
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for certain types of lymphoma, a blood cancer. Researchers aim to determine if a combination of modified immune cells (CART-45 cells) and stem cells (CD45BE-HSPC) is safe and effective. The trial includes two groups: one with B-cell lymphoma and another with T-cell and Hodgkin lymphoma. It targets individuals who have experienced relapsed or resistant forms of these cancers after previous treatments. Participants should have stable health conditions and no active infections or other major health issues.

As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you depend on systemic steroids or immunosuppressant medications, or if you have active autoimmune disease requiring certain treatments.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that CAR T-cell therapy, such as CART-45 cells, can help treat certain types of lymphomas, particularly those that are difficult to manage. However, these treatments also carry risks. Some patients may experience side effects, which can range from mild reactions to more serious issues.

Similarly, treatments involving CD45BE-HSPC remain in the early testing stages. As a phase 1 trial, the primary goal is to assess the treatment's safety and how well patients tolerate it. This phase marks the first step in human testing, with most safety information derived from earlier lab studies or similar treatments.

Prospective participants should discuss potential risks and benefits with the medical team. They can provide specific details about the treatment and its possible effects on individual patients.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about CART-45 and CD45BE-HSPC for lymphoma because these treatments offer a unique approach compared to traditional therapies like chemotherapy and radiation. CART-45 cells are engineered to specifically target and eliminate cancerous B-cells, which is different from the more general attack of chemotherapy. Meanwhile, CD45BE-HSPC involves using hematopoietic stem cells that are genetically modified to enhance the body's ability to regenerate healthy blood cells, potentially offering a more sustainable recovery option. This combination not only aims to improve the precision of cancer cell targeting but also supports the patient's recovery process by boosting healthy cell production.

What evidence suggests that this trial's treatments could be effective for lymphoma?

This trial will evaluate two separate treatments for lymphoma. Studies have shown that CART-45 cells, which participants in Cohort A may receive, can greatly improve outcomes for patients with Non-Hodgkin Lymphoma (NHL). One study showed that 81% of patients responded to the treatment, and 52% had no signs of cancer within three months. For patients with Richter's Transformation, a type of aggressive cancer, CAR T-cell therapy demonstrated a 76% response rate, with 66% of patients showing no signs of cancer, offering hope for this challenging condition.

Participants in Cohort B will receive CD45BE-HSPC, which uses modified stem cells. Although the specific effectiveness is still under investigation, similar stem cell transplants have shown promise, with up to 58% of NHL patients surviving for five years. These findings suggest that combining CART-45 cells with CD45BE-HSPC might provide a new way to treat difficult lymphoma cases.678910

Who Is on the Research Team?

NF

Noelle Frey, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for adults (18+) with certain types of lymphoma, including B-cell and T-cell lymphomas, who have relapsed or not responded after at least two previous treatments (not just single antibody therapy) and either failed or are ineligible for commercial CAR T cell therapy.

Inclusion Criteria

I have been diagnosed with follicular lymphoma.
I have relapsed after or am not eligible for commercial CAR T cell therapy.
I have been diagnosed with mantle cell lymphoma.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive autologous base edited anti-CD45 CAR T cells following an autologous transplant of CD45 base edited hematopoietic stem and progenitor cells

3 months

Follow-up

Participants are monitored for safety, efficacy, and overall survival

Up to 15 years

Dose-finding

Identification of the maximum tolerated dose and occurrence of dose-limiting toxicities

28 days post-CART-45 infusion

What Are the Treatments Tested in This Trial?

Interventions

  • CART-45 cells
  • CD45BE-HSPC

Trial Overview

The study tests a new treatment using the patient's own genetically edited stem cells (CD45BE-HSPC) followed by specially engineered immune cells called CART-45. The main goal is to find a safe dose and see how well this approach works in people with hard-to-treat blood cancers.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Cohort B: T-cell Non-Hodgkin Lymphoma (T-cell NHL), Hodgkin Lymphoma (HL)Experimental Treatment2 Interventions
Group II: Cohort A: B-cell Non-Hodgkin Lymphoma (B-cell NHL), Richter's Transformation (RT)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+

Kite, A Gilead Company

Industry Sponsor

Trials
45
Recruited
4,300+

Citations

Chimeric antigen receptor (CAR) -T cell therapy treatment ...

The 1-year and 2-year PFS rates were 35.7% and 28.9% respectively, and the 1-year and 2-year OS rates were 42.9% and 38.3% respectively (18).

Richter transformation in diffuse large B-cell lymphoma ...

Response to chemoimmunotherapy was achieved by 32% of patients. Median OS was 4.7 months, with cytopenia at DLBCL-RT diagnosis being the only ...

Richter Transformation: Clinical Manifestations, Evaluation ...

Richter transformation is a devastating and rare but not uncommon development of an aggressive B-cell lymphoma in patients with chronic lymphocytic leukemia.

International consensus statement on diagnosis, evaluation ...

DLBCL-RT, hereafter RT, is estimated to occur in 2% to 10% of patients with CLL, and is associated with a median overall survival (OS) of 6 to ...

CAR T-Cell Treatment Offers Hope for Richter Transformation

During a median follow up of 12.3 months, the overall response rate to liso-cel was 76%, with 66% achieving complete response. The median time ...

Richter transformation—is there light at the end of this tunnel?

Richter transformation (RT) represents an uncommon (2% to 10%) but feared complication of chronic lymphocytic leukemia (CLL).

Richter Transformation: Causes & Treatment

Richter transformation happens when a slow-growing cancer called chronic lymphocytic leukemia changes into an aggressive lymphoma.

Efficacy and Safety of CART Cell Therapy in Aggressive B‐ ...

CART therapy represents a highly effective approach for relapsed/refractory B-cell lymphomas. However, it also carries treatment-related risks.

Biology and Treatment of Richter Transformation - PMC

A bispecific CD37/CD19 CAR-T product is being developed to assess safety and efficacy in preclinical B-cell tumor models. Bispecific CD19/22 CAR-T cells have ...

CART-45 + CD45BE-HSPC for Lymphoma

This is a phase 1, open-label, dose-finding study to assess the safety, feasibility, pharmacokinetics and preliminary efficacy of autologous ...