Ensayos clínicos

Inclusion Criteria:  

Diagnosis of B-cell lymphoma, CLL or B-ALL as described below:  

• B-Cell Lymphoma:
  • Histologically documented lymphomas expected to express CD19;
  • Relapsed/refractory disease following at least 2 prior lines of multi-agent  immunochemotherapy.
• Chronic Lymphocytic Leukemia (CLL):
• Diagnosis of CLL per iwCLL guidelines;
  • Relapsed/refractory disease following at least two prior systemic treatment regimens.
• Precursor B-cell Acute Lymphocytic Leukemia (B-ALL):
  • 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.

ALL SUBJECTS

• 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.

Exclusion Criteria:  

ALL SUBJECTS

• 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.

Eligibility last updated 1/7/22. Questions regarding updates should be directed to the study team contact.