What side effects are associated with this type of intervention?

Common treatments for Follicular Lymphoma, particularly CAR-T cell therapy like CLBR001, are associated with significant side effects. These include cytokine release syndrome (CRS), which can cause fever, nausea, headache, rash, rapid heartbeat, low blood pressure, and trouble breathing. Neurological toxicities such as confusion, seizures, and severe headaches are also common. Additionally, patients may experience cytopenias (low blood cell counts), increased risk of infections, and potential long-term effects like secondary malignancies. These side effects are important considerations in treatment planning.

What prior FDA approvals exist?

The FDA has approved several CAR-T cell therapies for the treatment of various lymphomas, including follicular lymphoma. Notably, Tisagenlecleucel (Kymriah) and Axicabtagene Ciloleucel (Yescarta) are CAR-T cell therapies that have shown efficacy in treating relapsed or refractory B-cell lymphomas. These therapies involve genetically modifying a patient's T cells to target and kill cancer cells. While specific approvals for follicular lymphoma may vary, these CAR-T therapies represent a significant advancement in the treatment of lymphomas, including follicular lymphoma, by harnessing the body's immune system to fight cancer.

What other types of research exist?

Promising novel alternatives to CLBR001 CAR-T cells for Follicular Lymphoma patients include other anti-CD19 CAR-T cell therapies such as Lisocabtagene Maraleucel (liso-cel), Axicabtagene Ciloleucel, and Tisagenlecleucel. These therapies have demonstrated significant clinical activity with objective response rates of 83-93% in FL patients. Additionally, targeted therapies like ibrutinib, acalabrutinib, and venetoclax, often in combination with monoclonal antibodies such as obinutuzumab, are also emerging as effective treatment options.

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CAR T-cell Therapy

CLBR001 CAR-T for Non-Hodgkin's Lymphoma

Phase 1

Waitlist Available

Led By Carolyn Mulroney, M.D.

Research Sponsored by Calibr, a division of Scripps Research

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial involves monitoring patients who received a special cancer treatment using their own modified immune cells. These patients are followed for an extended period to check for safety and effectiveness. The treatment works by reprogramming the patient's immune cells to better fight cancer and has shown promising results.

Who is the study for?

This trial is for patients who have received at least one dose of CLBR001 CAR-T cells for various types of B-cell lymphomas and leukemias. Participants must be able to give informed consent and follow the study's visit schedule and requirements.

What is being tested?

The study follows up long-term with patients treated with genetically modified autologous CLBR001 CAR-T cells, possibly in combination with SWI019, to monitor ongoing effects after their initial treatment.

What are the potential side effects?

While specific side effects are not listed here, typical CAR-T therapy side effects can include cytokine release syndrome (flu-like symptoms), neurological events, low blood cell counts, infection risk increase, and infusion-related reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence and duration of new adverse events, late onset adverse events, and events of special interest

Incidence and duration of new serious adverse events

Incidence of new malignancies

+1 more

Secondary study objectives

Detectable replication competent lentivirus (RCL)

Duration of detection of ADA for CLBR001 and SWI019

Duration of response

+5 more

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: CLBR001 treated patientsExperimental Treatment1 Intervention

Patients who have been administered with CLBR001

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CLBR001 and SWI019

2020

Completed Phase 1

~20

Do I qualify?Apply below to find out

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

The most common treatments for Follicular Lymphoma include high-dose chemotherapy with autologous hematopoietic cell transplantation (HCT), nonmyeloablative or reduced intensity allogeneic HCT, and CAR-T cell therapy. High-dose chemotherapy with autologous HCT involves using high doses of chemotherapy to kill cancer cells, followed by the infusion of the patient's own stem cells to restore bone marrow function. Nonmyeloablative or reduced intensity allogeneic HCT uses lower doses of chemotherapy and radiation to suppress the immune system, followed by the infusion of donor stem cells, which can attack remaining cancer cells. CAR-T cell therapy involves genetically modifying a patient's T cells to express chimeric antigen receptors (CARs) that specifically target and kill cancer cells. This is particularly significant for Follicular Lymphoma patients as CAR-T cell therapy offers a targeted approach that can lead to long-term remissions, especially in cases where other treatments have failed.

Chimeric Antigen Receptor-T-Cell Therapy for B-Cell Hematological Malignancies: An Update of the Pivotal Clinical Trial Data.Chimeric antigen receptors for the adoptive T cell therapy of hematologic malignancies.New angles of attack in the fight against chronic lymphocytic leukemia: the advent of novel non-chemotherapeutic agents.