What side effects are associated with this type of intervention?

CD19-targeted therapies, including CAR-T cell therapies and monoclonal antibodies, are commonly used to treat B-cell malignancies. These treatments can cause a range of side effects. Common side effects of CAR-T cell therapy include cytokine release syndrome (CRS), which can lead to fever, fatigue, and low blood pressure, and neurotoxicity, which can result in confusion, seizures, and encephalopathy. Monoclonal antibodies, such as rituximab, can cause infusion-related reactions, including fever, chills, and allergic reactions, as well as increased risk of infections due to immunosuppression. Both types of therapies may also lead to cytopenias, such as neutropenia, anemia, and thrombocytopenia, which can increase the risk of infections and bleeding.

What prior FDA approvals exist?

Several FDA-approved therapies target CD19-positive B-cell malignancies. Notable among these are CAR-T cell therapies such as tisagenlecleucel (Kymriah) and axicabtagene ciloleucel (Yescarta), which reprogram a patient's T cells to target and kill CD19-expressing cancer cells. Additionally, monoclonal antibodies like rituximab (Rituxan) and obinutuzumab (Gazyva) target CD20, another B-cell marker, and are often used in combination with chemotherapy for enhanced efficacy. These therapies have significantly advanced the treatment landscape for B-cell malignancies by offering targeted, effective options for patients with relapsed or refractory disease.

What other types of research exist?

Promising alternatives to CNTY-101 for B-cell malignancies include: 1) Ibrutinib-based therapies (e.g., Ibrutinib plus Obinutuzumab), 2) Venetoclax plus Obinutuzumab, 3) Acalabrutinib-based therapies (e.g., Acalabrutinib plus Obinutuzumab), and 4) other CAR-T cell therapies targeting CD19, such as Axicabtagene Ciloleucel and Tisagenlecleucel. These therapies have shown efficacy in clinical trials and are viable options for patients in 2024.

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CAR T-cell Therapy

CNTY-101 for B-Cell Malignancies (ELiPSE-1 Trial)

Phase 1

Recruiting

Research Sponsored by Century Therapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Diagnosis of CD19-positive relapsed or refractory (R/R) B-cell Non-Hodgkin's Lymphoma (NHL)

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Must not have

Presence of clinically significant CNS pathology

Prior allogeneic stem cell transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment called CNTY-101 to see if it is safe and effective for patients whose B-cell cancers have come back or did not respond to previous treatments. The treatment works by targeting a marker called CD19 on the cancer cells.

Who is the study for?

This trial is for people with CD19-positive B-cell Non-Hodgkin's Lymphoma that has come back or hasn't responded to treatment. They must have tried at least two or three prior therapies, including a CD20-targeted agent and an anthracycline or alkylator. Participants should be fairly active (ECOG 0-1), have measurable disease, good organ function, and a life expectancy of over 12 weeks.

What is being tested?

The ELiPSE-1 study is testing CNTY-101 in patients with certain types of blood cancer. It's the first phase where they're figuring out safe doses, how the body processes the drug, and if it works well against these cancers. Patients will also receive lymphodepleting chemotherapy and IL-2 as part of their treatment.

What are the potential side effects?

Potential side effects may include reactions related to immune system activation such as fever and fatigue, effects from chemotherapy like nausea and hair loss, plus risks associated with new drugs like CNTY-101 which are being studied but could affect organs or cause allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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My lymphoma is CD19-positive and has come back or didn't respond to treatment.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

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

Select...

I have a significant brain or spinal cord condition.

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I have had a stem cell transplant from a donor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Complete Response Rate (CRR) Based on Percentage of Participants Achieving Complete Response (CR)

Duration of Response (DOR)

Objective Response Rate (ORR) Based on Percentage of Participants Achieving CR or Partial Response (PR)

+4 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose Escalation: Schedule BExperimental Treatment3 Interventions

LDC will be followed by administration of CNTY-101, 3 times over 3 weeks, alone or with supplemental IL-2.

Group II: Dose Escalation: Schedule AExperimental Treatment3 Interventions

Lymphodepleting chemotherapy (LDC) will be followed by single dose administration of CNTY-101, alone or with supplemental human recombinant interleukin 2 (IL-2).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

IL-2

2007

Completed Phase 4

~1100

0 / 4Eligibility 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

CD19-targeted therapies, such as CAR-T cell therapy and monoclonal antibodies, are pivotal in treating B Cell Malignancies. CAR-T cell therapy involves modifying a patient's T cells to express a receptor specific to CD19, a protein found on the surface of B cells, enabling these engineered T cells to identify and destroy malignant B cells. Monoclonal antibodies, like rituximab, also target CD19 or other B cell-specific antigens, marking the cancer cells for destruction by the immune system. These therapies are significant because they offer targeted treatment options that can lead to substantial remission rates in patients with relapsed or refractory B Cell Malignancies, providing hope where traditional therapies may have failed.