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CAR T-cell Therapy

CAR-T Therapy for T-Cell Lymphoma

Phase 1

Waitlist Available

Research Sponsored by Legend Biotech USA Inc

Eligibility Criteria Checklist

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

Must have

Subjects with confirmed CD30+ PTCL or MF must have previously received brentuximab vedotin.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

Study Summary

This trial is testing a new drug for people with certain types of T-cell lymphoma that have relapsed or are resistant to treatment.

Who is the study for?

Adults over 18 with CD4+ Peripheral T-cell lymphoma or Cutaneous T-cell lymphoma that's come back or hasn't responded to treatment. They must have tried at least two other cancer treatments, and if they've got a certain type of PTCL or mycosis fungoides, they need to have had brentuximab vedotin before. Participants should be fairly healthy (ECOG 0-1), not pregnant, willing to use birth control, and can't donate eggs or sperm for a year after the trial.Check my eligibility

What is being tested?

The study is testing LB1901, which is a new type of cell therapy called CAR-T specifically targeting CD4 cells in people with certain types of advanced T-cell lymphomas. It's an early-phase trial meant to see how safe it is and how well it works.See study design

What are the potential side effects?

As this is a first-in-human study for LB1901, specific side effects are unknown but may include symptoms common with CAR-T therapies such as fever, fatigue, immune reactions affecting different organs (cytokine release syndrome), neurological events like confusion or seizures (neurotoxicity), and potential infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

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

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I have CD30+ PTCL or MF and have been treated with brentuximab vedotin.

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I am fully active or can carry out light work.

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I am capable of becoming pregnant and have a negative pregnancy test.

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My cutaneous T-cell lymphoma is at stage IIB or higher.

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I have undergone at least two standard treatments for my condition.

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I am 18 years old or older.

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I have a donor for a stem cell transplant identified.

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My cancer is a type of T-cell lymphoma.

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I am 18 years old or older.

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My cancer is a type of T-cell lymphoma, confirmed by tests.

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My condition did not improve after two different cancer treatments.

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I have undergone at least two standard treatments for my condition.

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I have CD30+ PTCL or MF and have been treated with brentuximab vedotin.

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My cutaneous T-cell lymphoma is at stage IIB or higher.

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I have a donor for a stem cell transplant ready before joining the study.

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

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I agree not to donate eggs or sperm for 1 year after my last LB1901 treatment.

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My cancer has returned or didn't respond after two treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To characterize the safety and tolerability of LB1901 and determine the optimal dose or recommended dose for expansion (RDE).

To further characterize the safety and tolerability of LB1901 with the RDE identified in the dose escalation and determine the recommended Phase 2 dose (RP2D).

Secondary outcome measures

Disease control rate (DCR)

Duration of response (DOR)

Over all Response

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Experimental LB1901Experimental Treatment1 Intervention

Drug: anti-CD4 CAR T cells anti-CD4 CAR T cells transduced with a lentiviral vector to express CD4 chimeric receptor domain on T cells.

0 / 18Eligibility criteria met

Find a Location

Who is running the clinical trial?

Legend Biotech USA IncLead Sponsor

2 Previous Clinical Trials

97 Total Patients Enrolled

Media Library

LB1901 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04712864 — Phase 1

T-Cell Lymphoma Research Study Groups: Experimental LB1901

T-Cell Lymphoma Clinical Trial 2023: LB1901 Highlights & Side Effects. Trial Name: NCT04712864 — Phase 1

LB1901 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04712864 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any documented negative side effects of LB1901?

"Given that this is a Phase 1 trial with limited data supporting safety and efficacy, our team at Power rates LB1901 as a 1 on our safety scale."

Answered by AI

Could you please provide a count of how many hospitals are partaking in this experiment?

"To lessen the burden on participants, this clinical trial is enrolling patients at 4 sites which are situated in Rochester, Houston, Milwaukee and 4 other areas."

Answered by AI

Are we looking for more participants in this trial?

"Unfortunately, this specific study is not currently seeking participants according to the latest information available on clinicaltrials.gov. Although the trial was first posted on September 13th 2021 and last updated on February 15th 2022, there are plenty of other opportunities for patients looking to get involved in a clinical trial. In fact, 2717 trials are actively recruiting right now."

Answered by AI

What are the researchers' aims with this experiment?

"Based on the information provided by the trial sponsor, Legend Biotech USA Inc., the primary outcome of this study will be safety and tolerability, as measured over a period of up to 2 years. In addition to the primary outcome, this study will also evaluate secondary outcomes including time to response (TTR) and progression-free survival (PFS)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of CD4-Targeted Chimeric Antigen Receptor T-Cells (CD4- CAR-T) in Subjects With Relapsed or Refractory T-Cell Lymphoma

2021. "Study of CD4-Targeted Chimeric Antigen Receptor T-Cells (CD4- CAR-T) in Subjects With Relapsed or Refractory T-Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04712864.