Study of Tisagenlecleucel in Chinese Adult Patients With Relapsed or Refractory Diffuse Large B-cell Non-Hodgkin Lymphoma (DLBCL)

A Phase II, Single-arm, Multicenter Trial to Evaluate the Efficacy and Safety of Tisagenlecleucel in Chinese Adult Patients With Relapsed or Refractory Diffuse Large B-cell Non-Hodgkin Lymphoma (DLBCL)

ClinicalTrials.gov Identifier: NCT04456023

Novartis Reference Number: CCTL019C2203

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

This is a multi-center, phase II study to evaluate the efficacy and safety of CTL019 in Chinese adult patients with relapsed or refractory DLBCL.

Condition 
Diffuse Large B-Cell Lymphoma (DLBCL)
Phase 
Phase 2
Overall status 
Not yet recruiting
Enrollment count 
30 participants
Start date 
May 27, 2021
Completion date 
Mar 30, 2027
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Biological
Tisagenlecleucel
A single intravenous (i.v.) infusion of 0.6 - 6.0×10^8 CAR positive viable T cells.

Eligibility Criteria

Inclusion Criteria:

Signed informed consent must be obtained prior to participation in the study
Patients must be ≥18 years of age at the time of ICF signature
Histologically confirmed DLBCL at last relapse (including DLBCL transformed from follicular lymphoma and double-triple hit lymphoma)
Relapsed or refractory disease after at least 2 lines of systemic therapy, including anti-CD20 antibody and an anthracycline, or having failed or being ineligible for autologous HSCT
ECOG performance status that is either 0 or 1 at screening

Measurable disease at time of enrollment:

Nodal lesions greater than 15 mm in the long axis, regardless of the length of the short axis or
Extra nodal lesion (outside lymph node or nodal mass, but including liver and spleen) at least 10 mm in long and short axis
Adequate organ function
Must have a leukapheresis material of non-mobilized cells available for manufacturing

Exclusion Criteria:

Prior treatment with anti-CD19 therapy, adoptive T cell therapy, or any prior gene therapy product
Primary mediastinal large B-cell lymphoma, EBV+ DLBCL, Richter's transformation, Burkitt lymphoma, primary DLBCL of CNS, T cell / histiocyte rich large B-cell lymphoma, primary cutaneous DLBCL.
Eligible for and consenting to autologous HSCT
Prior allogeneic SCT
Active CNS involvement by disease under study, except if the CNS involvement has been effectively treated (i.e. patient is asymptomatic) and local treatment was greater than 4 weeks before enrollment
Active neurological autoimmune or inflammatory disorders (e.g. Guillain-Barre syndrome)
Investigational medicinal product within the last 30 days or five half-lives (whichever is longer) prior to screening

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Name: 
Novartis Pharmaceuticals
Phone: 
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]