NCT03344367UnknownPhase 1
A Phase 1, Open-Label Study of JWCAR029, CD19-targeted Chimeric Antigen Receptor (CAR) T Cells, for Adult Subjects With Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL)
Peking University2 sites in 1 country20 target enrollmentStarted: November 16, 2017Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Dose-limiting toxicities of JWCAR029
Study Overview
Brief Summary
This is a single arm, open-label, dose escalation clinical study to evaluate the safety and efficacy of infusion of autologous CD19-targeted chimeric antigen receptor (CD19 CAR) T cells in adult subjects with relapsed and refractory B-cell Non-Hodgkin lymphoma.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects must meet all of the following criteria to be enrolled in this study:
- •Age ≥ 18 years at the time of consent
- •Signed written informed consent obtained prior to any study procedures
- •Relapsed or refractory B-cell NHL.
- •PET-positive disease BY Lugano classification
- •Archived tumor biopsy tissue available from the last relapse and corresponding pathology report available or, if at least one tumor-involved site is deemed accessible at time of screening, willing to undergo pre-treatment biopsy (excisional when possible) for disease confirmation. If a subject has never had a complete response, a sample from the most recent biopsy is acceptable.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Adequate bone marrow, renal, hepatic, pulmonary and cardiac function
- •Adequate vascular access for leukapheresis procedure
- •Subjects who have received previous CD19-targeted therapy must have CD19-positive lymphoma confirmed on a biopsy since completing the prior CD19-targeted therapy
- •Subjects must agree to use appropriate contraception.
Exclusion Criteria
- •Subjects who meet any of the following criteria will be excluded from participation in this study:
- •Subjects with central nervous system (CNS)-only involvement by malignancy (note: subjects with secondary CNS involvement are allowed on study)
- •History of another primary malignancy that has not been in remission for at least 2 years.
- •Treatment with alemtuzumab within 6 months of leukapheresis, or treatment with fludarabine or cladribine within 3 months of leukapheresis
- •Active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection at the time of screening
- •Subjects with uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment at the time of leukapheresis or JWCAR029 administration
- •Presence of acute or chronic graft-versus-host disease (GVHD)
- •History of cardiovascular disease
- •History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
- •Pregnant or nursing women.
- •Prior CAR T-cell or other genetically-modified T-cell therapy, with the exception of prior JWCAR029 treatment in this protocol for subjects receiving retreatment
Arms & Interventions
JWCAR029
Experimental
The safety and efficacy of JWCAR029 will be evaluated in a standard 3+3 dose escalation approach. 5 CAR T dosage will be tested in this study: 1×10^7, 2.5×10^7, 5×10^7, 1×10^8, 1.5^108 CAR+ T cells.
Intervention: JWCAR029 (Biological)
Outcomes
Primary Outcomes
Dose-limiting toxicities of JWCAR029
Time Frame: 28 days after JWCAR029 infusion
Physiological parameter
Treatment-related adverse events (AEs)
Time Frame: 2 years
Physiological parameter
Objective response rate (ORR)
Time Frame: 2 years
Lugano criteria
Secondary Outcomes
- Maximum concentration (Cmax) of JWCAR029 in the peripheral blood and bone marrow(1 year after JWCAR029 infusion)
- Time to maximum concentration (Tmax) of JWCAR029 in the peripheral blood and bone marrow(1 year after JWCAR029 infusion)
- Health-related quality of life (HRQoL)(2 years)
- Area-under the concentration-vs-time-curve (AUC) of JWCAR029 in the peripheral blood and bone marrow(1 year after JWCAR029 infusion)
- Duration of response(2 years)
- Progression-free survival (PFS) and PFS ratio(2 years)
- Complete response (CR) rate(2 years)
- Overall survival(2 years)
Investigators
Jun Zhu
Professor
Peking University Cancer Hospital & Institute
Study Sites (2)
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