What side effects are associated with this type of intervention?

Adoptive T cell therapies for lymphoma, such as CAR T-cell therapy, commonly cause cytokine release syndrome (CRS), leading to fever, hypotension, and organ dysfunction. Neurological toxicities, including confusion and seizures, are also frequent. Rimiducid, used to mitigate acute graft-versus-host disease (aGvHD), can result in immune suppression-related side effects, such as increased infection risk and potential organ toxicity. These treatments necessitate careful monitoring and supportive care to manage these adverse effects.

What prior FDA approvals exist?

The FDA has approved several adoptive T cell therapies for the treatment of lymphoma. Notably, chimeric antigen receptor (CAR) T cell therapies such as axicabtagene ciloleucel (Yescarta) and tisagenlecleucel (Kymriah) have been approved for certain types of relapsed or refractory large B-cell lymphoma. These therapies involve modifying a patient's T cells to target and kill cancer cells. Additionally, the FDA has approved drugs like rituximab, an anti-CD20 monoclonal antibody, which is often used in combination with other therapies for various types of lymphoma. While specific information on BPX-501 T cell infusion and Rimiducid is limited, these approved therapies share the common goal of enhancing the immune system's ability to fight lymphoma.

What other types of research exist?

Promising novel alternatives for lymphoma patients include: 1) Ublituximab, a glycoengineered anti-CD20 monoclonal antibody, which has shown efficacy in rituximab-relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) and chronic lymphocytic leukemia (CLL). 2) Bispecific antibodies like Blinatumomab, which engage T cells to target B-cell malignancies. 3) Antibody-drug conjugates such as Brentuximab vedotin, which deliver cytotoxic agents directly to cancer cells. 4) Checkpoint inhibitors like Pembrolizumab, which enhance the immune response against tumor cells. These alternatives offer targeted approaches to treating lymphoma and managing associated complications.

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CAR T-cell Therapy

BPX-501 + Rimiducid for Leukemia

Phase 1

Waitlist Available

Research Sponsored by Bellicum Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Clinical diagnosis of one of the following adult hematological malignancies: Leukemia, Myelodysplastic Syndromes, Lymphomas, Multiple myeloma, Other high-risk hematologic malignancies eligible for stem cell transplantation per institutional standard

Performance status: Karnofsky score > 50%

Must not have

Active CNS involvement by malignant cells

≥ Grade II acute GVHD or chronic extensive GVHD due to a previous allograft at time of screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 24

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a treatment for adults with certain blood cancers after a transplant. The treatment aims to fight cancer and infections while controlling side effects with another drug.

Who is the study for?

Adults aged 18-65 with certain blood cancers like leukemia, lymphoma, or myeloma who've had a stem cell transplant but are seeing their cancer return. They need to be relatively healthy otherwise, with good heart, liver, kidney and lung function and no severe complications from the transplant.

What is being tested?

The trial is testing BPX-501 T cells given in increasing doses to see if they can fight the cancer after a stem cell transplant. It's also looking at Rimiducid's ability to control graft versus host disease without hurting the anti-cancer effects of the T cells.

What are the potential side effects?

Potential side effects may include immune reactions due to infused T cells or symptoms related to graft versus host disease management. Specific side effect profiles for BPX-501 and Rimiducid will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a blood cancer that may require a stem cell transplant.

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I am able to live my life with some degree of normalcy.

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My donor is at least a half match for me based on specific genetic markers.

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I am between 18 and 65 years old.

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Your bone marrow, heart, liver, kidneys, and lungs must be working well according to specific measurements.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to my brain or spinal cord.

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I have had a severe reaction to a previous transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

BPX-501 Safety

GvHD

Rimiducid Activity

+2 more

Secondary study objectives

Response Rate

Translational

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: BPX-501 and RimiducidExperimental Treatment2 Interventions

All subjects will receive 3 cycles of BPX-501 T cell infusions at escalating dose levels (DL). DL1 on Day 0, DL2 on Days 30 and 60. The first dose of BPX-501 T cells will occur ≥30 days after hematopoietic stem cell transplant (HSCT). Two doses of Rimiducid ( 0.1 mg/kg and 0.4 mg/kg) will be investigated for the treatment of aGvHD after BPX-501 T cell infusion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rimiducid

2019

Completed Phase 1

~20

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Adoptive T cell therapy, such as BPX-501 T cell infusion, involves modifying a patient's T cells to enhance their ability to target and destroy cancer cells, offering a targeted approach to eliminate residual disease. Rimiducid mitigates acute graft-versus-host disease (aGvHD) by activating a safety switch in the modified T cells, ensuring the therapy remains safe and effective. This combination of targeted action and safety mechanisms is crucial for improving outcomes and reducing complications in lymphoma treatment.