Status:
UNKNOWN
Study of CD4-Targeted Chimeric Antigen Receptor T-Cells (CD4- CAR-T) in Subjects With Relapsed or Refractory T-Cell Lymphoma
Lead Sponsor:
Legend Biotech USA Inc
Conditions:
T-Cell Lymphoma
Peripheral T-Cell Lymphoma Refractory
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 (P...
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 Per...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
September 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04712864
Start Date
September 13 2021
End Date
December 1 2025
Last Update
October 3 2023
Active Locations (4)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905
2
MD Anderson Cancer Center
Houston, Texas, United States, 77030
3
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98195
4
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226