36 Participants Needed

BAFFR-targeting CAR T Cells for B-Cell Lymphoma

Recruiting at 5 trial locations
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Overseen ByDeShaun Noakes, M.S.
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 called BAFFR-CAR T cells for individuals with B-cell Non-Hodgkin's Lymphoma that hasn't responded to other treatments. The researchers aim to determine if this treatment can combat the cancer and assess its safety. Individuals diagnosed with B-cell Non-Hodgkin's Lymphoma, showing evidence of the disease on scans or in their blood, may be suitable for this trial, especially if their cancer did not improve with other treatments. 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, but you cannot be on systemic steroids or chronic immunosuppressants. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that BAFFR-CAR T cells are likely to be safe for humans?

Research has shown that BAFFR-CAR T cells have been safe in early studies. In one study involving patients with B-cell leukemia, these cells proved both safe and effective against the disease. Another study found that even at low doses, these cells remained effective and safe over time. While these results are promising, they stem from early research. More studies are needed to fully understand the safety of BAFFR-CAR T cells for treating B-cell lymphoma.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for B-cell lymphoma, which often include chemotherapy and monoclonal antibodies targeting CD20, BAFFR-CAR T cells offer a new approach by specifically targeting the B-cell activating factor receptor (BAFFR). This innovative mechanism allows the CAR T cells to hone in on a different receptor on the cancerous B-cells, potentially overcoming resistance seen with current therapies. Researchers are excited because this targeted approach might improve effectiveness and reduce side effects, offering hope for patients with relapsed or refractory B-cell non-Hodgkin lymphoma.

What evidence suggests that BAFFR-CAR T cells might be an effective treatment for B-cell lymphoma?

Research has shown that a new treatment using BAFFR-CAR T cells, which participants in this trial will receive, could help treat B-cell lymphomas, especially when other treatments like CD19-targeted therapy have failed. These specialized cells target a protein called BAFFR on cancer cells, aiding in their destruction. Early studies have found this method to be safe and effective against B-cell cancers, which include various types of lymphomas. Specifically, one study demonstrated that BAFFR-CAR T cells successfully shrank or controlled tumors. This suggests that these cells might offer a new option for patients with relapsed or difficult-to-treat B-cell lymphoma.12456

Who Is on the Research Team?

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Elizabeth Budde, MD

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

Adults with B-cell Non-Hodgkin's Lymphoma that has returned or didn't respond to at least one treatment can join. They must be physically capable (ECOG ≤ 2), have a certain level of organ function, and not be pregnant or breastfeeding. People who've had other cancers recently, major heart issues, immune deficiencies, uncontrolled infections, CNS lymphoma involvement within the last 3 months, or are on steroids/immunosuppressants can't participate.

Inclusion Criteria

Specific blood count requirements
AST < 3 x ULN
Left ventricular ejection fraction (LVEF) ≥ 45%
See 16 more

Exclusion Criteria

I have an ongoing infection that needs treatment with antibiotics or antifungals.
History of allergic reactions to compounds of similar composition to study agent
Primary immunodeficiency
See 17 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lymphodepletion

Participants undergo lymphodepletion to prepare for CAR T cell infusion

1 week

Treatment

Participants receive BAFFR-CAR T cells to target B-cell Non-Hodgkin's Lymphoma

1 day (infusion)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 1 year

Long-term Follow-up

Participants are monitored for progression-free survival and overall survival

Up to 15 years

What Are the Treatments Tested in This Trial?

Interventions

  • BAFFR-CAR T cells
Trial Overview The trial is testing BAFFR-CAR T cells in patients whose B-NHL has come back or hasn't responded to treatments. It's an early-phase study to see how safe it is and what effects it has on this type of lymphoma. Participants will receive genetically modified T cells designed to target and kill cancer cells.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: B-cell activating factor receptor-Chimeric antigen receptor T cells [BAFFR-CAR T cells]Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

PeproMene Bio, Inc.

Lead Sponsor

Trials
2
Recruited
60+

City of Hope Medical Center

Collaborator

Trials
614
Recruited
1,924,000+

Published Research Related to This Trial

Chimeric antigen receptor (CAR) T-cell therapies, particularly those targeting CD19, have shown significant efficacy in treating B-cell malignancies, including aggressive forms like B-cell acute lymphoblastic leukemia and non-Hodgkin lymphomas.
Despite their success, many patients do not respond or relapse after treatment, prompting research into alternative CAR targets such as CD20, CD22, and others, as well as combination therapies to improve outcomes.
CAR-T cell Therapies for B-cell Lymphoid Malignancies: Identifying Targets Beyond CD19.Vanegas, YM., Mohty, R., Gadd, ME., et al.[2022]
The novel BAFF-R CAR T-cell therapy shows promise in treating B-cell malignancies, particularly in cases where traditional CD19-targeted therapies may fail due to antigen loss, with effective elimination of BAFF-R expressing tumors demonstrated in mouse models.
This therapy has been developed under strict manufacturing standards and has passed necessary FDA testing, paving the way for a Phase 1 clinical trial in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL).
Antitumor efficacy of BAFF-R targeting CAR T cells manufactured under clinic-ready conditions.Dong, Z., Cheng, WA., Smith, DL., et al.[2020]
Adoptive cellular immunotherapy using anti-CD19 CAR-T cells has significantly improved treatment outcomes for patients with relapsed or refractory B cell lymphomas, leading to durable remissions, with two products already FDA-approved and a third in large clinical trials.
Despite their effectiveness, CAR-T cell therapies can cause serious side effects like infections and cytokine release syndrome, highlighting the need for better understanding of these toxicities and strategies to mitigate them.
Recent Advances in CAR-T Cell Therapy for Non-Hodgkin Lymphoma.Kallam, A., Vose, JM.[2020]

Citations

PMB-CT01 (BAFFR-CAR T cell) therapy to examine ...BAFFR-CAR T cells are a promising therapeutic option for patients with r/r B-cell malignancies who are ineligible or failed prior CD19-targeted therapy.
Study Details | NCT04690595 | BAFFR Targeting CAR-T ...This phase I trial evaluates the side effects and best dose of BAFFR-CAR T cells in treating patients with B-cell Acute Lymphoblastic Leukemia that has come ...
CAR T cells targeting BAFF-R can overcome CD19 antigen ...CAR T cells targeting CD19 provide promising options for treatment of B cell malignancies. However, tumor relapse from antigen loss can limit efficacy.
Use of BAFFR CAR-T to treat B cell leukemia/lymphoma ...The results of this study suggest that BAFFR is an active and promising immunotherapeutic target for B-cell malignancies and auto-immune diseases.
Promising Safety and Anti-Lymphoma Efficacy of Autologous ...Promising safety and anti-lymphoma efficacy of autologous Pmb-CT01 (BAFFRCAR T Cell) therapy in a first-in-human Phase 1 study.
Favorable Safety Profile and Durable Responses to Pmb ...Conclusions: With a 100% CR rate, including durable responses at dose level 1 and a favorable initial safety profile, BAFFR-CAR T cells ...
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