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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03344367
Other study ID # JWCAR029-001
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date November 16, 2017
Est. completion date March 2022

Study information

Verified date July 2019
Source Peking University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 20
Est. completion date March 2022
Est. primary completion date October 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Subjects must meet all of the following criteria to be enrolled in this study:

1. Age = 18 years at the time of consent

2. Signed written informed consent obtained prior to any study procedures

3. Relapsed or refractory B-cell NHL.

4. PET-positive disease BY Lugano classification

5. 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.

6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

7. Adequate bone marrow, renal, hepatic, pulmonary and cardiac function

8. Adequate vascular access for leukapheresis procedure

9. Subjects who have received previous CD19-targeted therapy must have CD19-positive lymphoma confirmed on a biopsy since completing the prior CD19-targeted therapy

10. 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:

1. Subjects with central nervous system (CNS)-only involvement by malignancy (note: subjects with secondary CNS involvement are allowed on study)

2. History of another primary malignancy that has not been in remission for at least 2 years.

3. Treatment with alemtuzumab within 6 months of leukapheresis, or treatment with fludarabine or cladribine within 3 months of leukapheresis

4. Active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection at the time of screening

5. Subjects with uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment at the time of leukapheresis or JWCAR029 administration

6. Presence of acute or chronic graft-versus-host disease (GVHD)

7. History of cardiovascular disease

8. 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

9. Pregnant or nursing women.

10. 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

Study Design


Intervention

Biological:
JWCAR029
Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JWCAR029. During JWCAR029 production, subjects will receive a conditioning chemotherapy regimen of cyclophosphamide and fludarabine for the purpose of lymphocytes depletion. After lymphodepletion, subjects will receive one dose treatment with JWCAR029 by intravenous (IV) injection.

Locations

Country Name City State
China Beijing Cancer Hospital Beijing

Sponsors (2)

Lead Sponsor Collaborator
Peking University Shanghai Mingju Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Treatment-related adverse events (AEs) Physiological parameter 2 years
Primary Dose-limiting toxicities of JWCAR029 Physiological parameter 28 days after JWCAR029 infusion
Primary Objective response rate (ORR) Lugano criteria 2 years
Secondary Maximum concentration (Cmax) of JWCAR029 in the peripheral blood and bone marrow Flow cytometry and qPCR 1 year after JWCAR029 infusion
Secondary Time to maximum concentration (Tmax) of JWCAR029 in the peripheral blood and bone marrow Flow cytometry and qPCR 1 year after JWCAR029 infusion
Secondary Area-under the concentration-vs-time-curve (AUC) of JWCAR029 in the peripheral blood and bone marrow Flow cytometry and qPCR 1 year after JWCAR029 infusion
Secondary Complete response (CR) rate Lugano criteria 2 years
Secondary Duration of response Lugano criteria 2 years
Secondary Progression-free survival (PFS) and PFS ratio Lugano criteria 2 years
Secondary Overall survival Physiological parameter 2 years
Secondary Health-related quality of life (HRQoL) Questionnaire 2 years
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