CAR-T Therapy for T-Cell Lymphoma

Recruiting at 3 trial locations

Overseen By Legend Biotech

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Legend Biotech USA Inc

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a Phase 1, first-in-human (FIH), open-label, multicenter, study of LB1901 administered to adult subjects with histologically confirmed CD4+ relapsed or refractory Peripheral T-cell lymphoma (PTCL) (PTCL not otherwise specified \[PTCL-NOS\] and angioimmunoblastic \[AITL\]), or relapsed or refractory cutaneous T-cell lymphoma (CTCL) (Sézary syndrome \[SS\] and mycosis fungoides \[MF\]).

Eligibility Criteria

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.

Inclusion Criteria

Written informed consent.

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

I am fully active or can carry out light work.

Exclusion Criteria

I haven't taken immunomodulatory drugs in the last 7 days.

I haven't taken any monoclonal antibody treatments in the last 4 weeks.

My cancer was fully treated or removed and has been in remission for over 3 years.

Treatment Details

Interventions

• LB1901 (CAR T-cell Therapy)

Trial Overview 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.

Participant Groups

Group I: Experimental LB1901 Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Legend Biotech USA Inc

Lead Sponsor

Trials

3

Recruited

150+