50 Participants Needed

CAR-T Therapy for T-Cell Lymphoma

Recruiting at 3 trial locations
LB
Overseen ByLegend Biotech
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

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.
See 25 more

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.
See 25 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive anti-CD4 CAR T cells transduced with a lentiviral vector to express CD4 chimeric receptor domain on T cells

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 4 years

Treatment Details

Interventions

  • LB1901
Trial OverviewThe 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
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Legend Biotech USA Inc

Lead Sponsor

Trials
3
Recruited
150+

Findings from Research

CD19-directed CAR-T therapy has shown promising long-term results, achieving durable remissions in nearly 50% of patients with relapsed/refractory large B-cell lymphoma, significantly improving their prognosis compared to the previous median survival of about 6 months with standard treatments.
The success of CAR-T therapy in large B-cell lymphoma has led to its expansion into other types of lymphomas, such as mantle cell and follicular lymphoma, and ongoing development of new CAR-T platforms aimed at enhancing efficacy and reducing toxicity.
New Indications and platforms for CAR-T therapy in lymphomas beyond DLBCL.Iqbal, M., Savani, BN., Hamadani, M.[2023]
The ZUMA-7 trial showed that axicabtagene ciloleucel (axi-cel) significantly improves overall survival and event-free survival compared to standard-of-care treatments for early-relapsed or refractory large B cell lymphoma, marking a major advancement in treatment options after nearly 30 years.
CAR T cell therapies, particularly axi-cel and lisocabtagene maraleucel (liso-cel), are proving effective as second-line treatments for elderly and transplant-ineligible patients, with potential for use as first-line therapies for high-risk large B cell lymphoma.
Evolving Role of CAR T Cell Therapy in First- and Second-Line Treatment of Large B Cell Lymphoma.Lionel, AC., Westin, J.[2023]
In a phase 1 clinical trial involving 14 patients with relapsed/refractory acute lymphoblastic leukemia (ALL) and non-Hodgkin lymphoma (NHL), the novel Sleeping Beauty (SB) CD19-specific CAR T-cell therapy demonstrated a strong safety profile, with no serious adverse events directly linked to the treatment and only mild cytokine release syndrome observed.
Efficacy results showed that 38% of patients with ALL achieved complete remission or incomplete count recovery, and 50% of patients with diffuse large B-cell lymphoma (DLBCL) also achieved complete remission, indicating promising antitumor activity of the SB-based CAR constructs.
Sleeping beauty generated CD19 CAR T-Cell therapy for advanced B-Cell hematological malignancies.Singh, H., Srour, SA., Milton, DR., et al.[2023]

References

New Indications and platforms for CAR-T therapy in lymphomas beyond DLBCL. [2023]
Management of relapsed or refractory large B-cell lymphoma in patients ineligible for CAR-T cell therapy. [2022]
Evolving Role of CAR T Cell Therapy in First- and Second-Line Treatment of Large B Cell Lymphoma. [2023]
CD22-directed CAR T-cell therapy induces complete remissions in CD19-directed CAR-refractory large B-cell lymphoma. [2022]
Constant attack on T cell lymphomas. [2018]
Sleeping beauty generated CD19 CAR T-Cell therapy for advanced B-Cell hematological malignancies. [2023]
CAR-T Cell Therapy in Diffuse Large B Cell Lymphoma: Hype and Hope. [2020]
Axicabtagene ciloleucel as first-line therapy in high-risk large B-cell lymphoma: the phase 2 ZUMA-12 trial. [2023]
Efficacy and Safety of Innovative Experimental Chimeric Antigen Receptor (CAR) T-cells versus Axicabtagene ciloleucel (Yescarta) for the Treatment of Relapsed/Refractory Large B-Cell Lymphoma (LBCL): Matching Adjusted Indirect Comparisons (MAICs) and Systematic Review. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
GLA/DRST real-world outcome analysis of CAR T-cell therapies for large B-cell lymphoma in Germany. [2022]
[CAR T-cell therapy for malignant B-cell lymphoma : A new treatment paradigm]. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
Targeting T-cell malignancies using anti-CD4 CAR NK-92 cells. [2023]
CAR T-cell therapy in large B cell lymphoma. [2023]