CAR-T Therapy for T-Cell Lymphoma
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 \[MF\]).
Will I have to stop taking my current medications?
The trial requires stopping certain medications before participating. You must stop any systemic anticancer therapy, immunosuppressants, therapeutic anticoagulants, and CNS disease prophylaxis within specific timeframes before apheresis (blood collection).
What data supports the effectiveness of the treatment LB1901 for T-Cell Lymphoma?
CAR-T therapy has shown success in treating other types of lymphomas, such as large B-cell lymphoma, with durable remissions in nearly half of the patients. This success has led to the expansion of CAR-T therapy to other lymphoma types, suggesting potential effectiveness for T-cell lymphoma as well.12345
Is CAR-T therapy generally safe for humans?
CAR-T therapy has shown a manageable safety profile in various studies, with common side effects including cytokine release syndrome (a reaction where the immune system releases too many proteins into the blood too quickly) and neurotoxicity (nerve damage). These side effects are generally manageable with proper medical care, and no severe adverse events were directly attributed to the treatment in some trials.678910
How is the treatment LB1901 for T-Cell Lymphoma different from other treatments?
LB1901 is a CAR-T therapy, which is a type of treatment that uses genetically modified T-cells to target and destroy cancer cells. This approach is unique because it specifically targets the T-cell receptor β-chain constant region 1, offering a new way to treat T-cell lymphomas, which currently have limited standard treatment options.15111213
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive anti-CD4 CAR T cells transduced with a lentiviral vector to express CD4 chimeric receptor domain on T cells
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- LB1901
Find a Clinic Near You
Who Is Running the Clinical Trial?
Legend Biotech USA Inc
Lead Sponsor