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FT819 in Subjects With B-cell Malignancies

Trial ID or NCT#

NCT04629729

Status

not recruiting iconNOT RECRUITING

Purpose

This is a Phase I dose-finding study of FT819 as monotherapy and in combination with IL-2 in subjects with relapsed/refractory B-cell Lymphoma, Chronic Lymphocytic Leukemia and Precursor B-cell Acute Lymphoblastic Leukemia. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.

Official Title

A Phase I Study of FT819 in Subjects With B-cell Malignancies

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
  1. Diagnosis of B-cell lymphoma, CLL or B-ALL as described below:
  2. B-Cell Lymphoma:
    1. * Histologically documented lymphomas expected to express CD19* Relapsed/refractory disease following at least 2 prior lines of multi-agent immunochemotherapy
  3. Chronic Lymphocytic Leukemia (CLL):
    1. * Diagnosis of CLL per iwCLL guidelines* Relapsed/refractory disease following at least two prior systemic treatment regimens
  4. Precursor B-cell Acute Lymphocytic Leukemia (B-ALL):
    1. * Diagnosis of B-ALL by flow cytometry, bone marrow histology, and/or cytogenetics* Relapsed/refractory disease after at least 2 cycles of standard multiagent induction chemotherapy. For subjects with Philadelphia-chromosome positive (Ph+) disease, failure or intolerance to a tyrosine kinase inhibitor therapy-containing regimen
  5. ALL SUBJECTS:
    1. * Capable of giving signed informed consent* Age ≥ 18 years old* Stated willingness to comply with study procedures and duration* Contraceptive use for women and men as defined in the protocol
  6. Key
Exclusion Criteria:
  1. ALL SUBJECTS:
    1. * Females who are pregnant or breastfeeding* Eastern Cooperative Oncology Group (ECOG) Performance Status ≥2* Body weight \<50 kg* Evidence of insufficient organ function* Receipt of therapy within 2 weeks prior to Day 1 or five half-lives, whichever is shorter; or any investigational therapy within 28 days prior to Day 1* Currently receiving or likely to require systemic immunosuppressive therapy* Ongoing requirement for systemic GvHD therapy following prior allogeneic hematopoietic stem cell transplant (HSCT) or allogeneic CAR-T* Receipt of an allograft organ transplant* Known active central nervous system (CNS) involvement by malignancy* Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease* Clinically significant cardiovascular disease* Positive serologic test results for HIV infection* Positive serologic and polymerase chain reaction (PCR) test results for Hepatitis B (HBV) infection* Positive serologic and PCR test results for Hepatitis C (HCV) infection* Live vaccine \<6 weeks prior to start of lympho-conditioning* Known allergy to albumin (human) or DMSO
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Investigator(s)

David Miklos
David Miklos
Blood and marrow transplant specialist, Blood and marrow transplant specialist, Hematologist, Medical oncologist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Contact us to find out if this trial is right for you.

Contact

Maria Iglesias
+1 650-723-4247

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