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T-Cell LymphomaPhase 1NCT04712864

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

A Phase 1 study testing LB1901 in people with T-Cell Lymphoma and Peripheral T-Cell Lymphoma Refractory, run by Legend Biotech USA Inc at 4 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
LB1901
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
4 sitesUnited States
Study dates
13 Sep 2021to Dec 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent.
  • Subjects ≥ 18 years of age.
  • Histologically confirmed diagnosis of CD4+ PTCL-NOS; OR CD4+ AITL; OR CD4+ CTCL(either MF or SS).
  • Relapsed or refractory disease with at least two prior lines of systemic antineoplastic therapy.
  • Subjects with confirmed CD30+ PTCL or MF must have previously received brentuximab vedotin.
  • Subjects should have received at least two prior lines of standard of care therapies.
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  • For Subjects with PTCL-NOS or AITL, at least one measurable lesion according to the International Working Group (IWG) Response Criteria.
  • For subjects with CTCL, disease stage IIB or higher based on TNMB system.
  • Subjects must have an identified hematopoietic stem cell transplant (HSCT) donor available prior to enrollment. HLA typing may be performed for source identification.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate organ function.
  • Women of childbearing potential must have a negative pregnancy test at screening.
  • All Subject must agree to practice a highly effective method of contraception.
  • Women and men must agree not to donate eggs (ova, oocytes) or sperm, respectively, until at least 1 year after receiving a LB1901.

Who cannot join

  • Histologically confirmed CD8+ TCL - CD8 positivity in tumor must be confirmed within 3 months prior to apheresis by IHC or flow cytometry.
  • Prior treatment with cellular immunotherapy (e.g., CAR-T) or gene therapy product directed at any target.
  • Prior treatment with CD4-targeted therapy.
  • History of allogeneic haematopoietic stem cells transplant.
  • Antitumor therapy prior to apheresis as follows:
  • Any systemic anticancer therapy (chemotherapy, targeted therapy including ADC, epigenetic therapy including HDAC inhibitor, retinoids, pralatrexate, proteasome inhibitor therapy, investigational drug) within 21 days or at least 5 half-lives, whichever is shorter.
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  • Anti-CCR4 monoclonal antibody or any other monoclonal antibody within 4 weeks or at least 5 half-lives, whichever is shorter.
  • Cytotoxic therapy within 14 days.
  • Immunomodulatory agent therapy within 7 days.
  • Radiotherapy within 14 days.
  • Immunosuppressant (e.g., cyclosporine or systemic steroids) above physiologic dosing within 7 days of apheresis.
  • Therapeutic anticoagulants (such as warfarin, heparin, low molecular weight heparin) (at least 3 half-lives must have elapsed after the last dose at the time of apheresis).
  • CNS disease prophylaxis (e.g., intrathecal methotrexate) at least 7 days before apheresis.
  • History or active Hepatitis B or C infection (except hepatitis C cured with pharmacotherapy); or history of or current HIV infection.
  • History of autoimmune disease requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years.
  • Primary immunodeficiency.
  • Active CNS disease related to the underlying malignancy.
  • Stroke or seizure within 6 months of apheresis.
  • Impaired cardiac function or clinically significant cardiac disease.
  • Previous or concurrent malignancy with the following exceptions:
  • Adequately treated basal cell or squamous cell carcinoma.
  • In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to screening.
  • A primary malignancy which has been completely resected, or treated, and is in complete remission for at least 3 years prior to screening.
  • Serious and/or uncontrolled medical condition that, in the Investigator's judgment, would cause unacceptable safety risk.
  • Ongoing toxicity from previous anticancer therapy that has not resolved to baseline levels or to Grade 1 or less, except for alopecia, fatigue, nausea, and constipation.
  • Major surgery within 4 weeks prior to apheresis, or planned within 4 weeks after LB1901 administration.
  • Contraindications or life-threatening allergies, hypersensitivity, or intolerance to LB1901 or its excipients, including dimethyl sulfoxide; or to fludarabine, cyclophosphamide, or tocilizumab.
  • Contraindication or life-threatening allergy to valacyclovir, unless another suitable option of antiviral prophylaxis is identified after consultation with an Infectious Disease specialist.
  • Pregnant or breast-feeding.
  • Plans to become pregnant or breastfeed, or father a child within 1 year after receiving a LB1901 infusion.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98195

Other trials in United States

About this study

Official title: A Phase 1, First-In-Human, Open-Label, Multicenter, Multicohort Study of CD4-Targeted Chimeric Antigen Receptor T-Cells (CD4- CAR-T) in Subjects With Relapsed or Refractory T-Cell Lymphoma

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]).

Read the detailed description

Study Design: This is a Phase 1, first-in-human (FIH), open-label, multicenter, multicohort 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]).

Being tested
LB1901
Medical subject headings
Lymphoma, T-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LB1901Biological

    LB1901 - an autologous CD4-targeted CAR-T immunotherapy

Study groups in NCT04712864
Study groupRoleWhat they receive
Experimental LB1901ExperimentalDrug: anti-CD4 CAR T cells anti-CD4 CAR T cells transduced with a lentiviral vector to express CD4 chimeric receptor domain on T cells.
Receives: Biological: LB1901

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Multiple doses will be tested to establish a recommended dose.

    Measured: Up to 2 years

  2. 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).

    Treatment of additional patients at the recommended dose as identified in the initial dose escalation part of the study.

    Measured: Up to 2 years

Secondary outcomes (6)

  1. Over all Response

    Based on International Working Group Response Criteria for PTCL. Global Composite Response for CTCL

    Measured: Up to 4 years

  2. Time to response (TTR)

    Based on International Working Group Response Criteria for PTCL. Global Composite Response for CTCL

    Measured: Up to 4 years

  3. Duration of response (DOR)

    Based on International Working Group Response Criteria for PTCL. Global Composite Response for CTCL

    Measured: Up to 4 years

  4. Disease control rate (DCR)

    Based on International Working Group Response Criteria for PTCL. Global Composite Response for CTCL

    Measured: Up to 4 years

  5. Progression-free survival (PFS)

    Based on International Working Group Response Criteria for PTCL. Global Composite Response for CTCL

    Measured: Up to 4 years

  6. Overall survival (OS)

    Based on International Working Group Response Criteria for PTCL. Global Composite Response for CTCL

    Measured: Up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2021
  2. Study start13 Sep 2021
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04712864
Sponsor's protocol ID
LB1901-TCL-1001
Status last verified
Oct 2023
First submitted
1 Dec 2020
Last updated
3 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LB1901 in people with T-Cell Lymphoma and Peripheral T-Cell Lymphoma Refractory, run by Legend Biotech USA Inc at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To characterize the safety and tolerability of LB1901 and determine the optimal dose or recommended dose for expansion (RDE). (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04712864.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.

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