Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04456023
Other study ID # CCTL019C2203
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date January 31, 2022
Est. completion date September 27, 2027

Study information

Verified date February 2022
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Disease assessments will be performed at screening, after bridging, 1, 3, 6, 9 and 12 months after tisagenlecleucel infusion, and every 6 months in the second year, and annually up to 60 months after infusion. Efficacy will be assessed until progression; safety will be assessed throughout the study. A long term follow-up up to 15 years after CTL019 infusion will continue under a separate protocol (CCTL019A2205B)(NCT02445222).


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date September 27, 2027
Est. primary completion date October 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Signed informed consent must be obtained prior to participation in the study 2. Patients must be =18 years of age at the time of ICF signature 3. Histologically confirmed DLBCL at last relapse (including DLBCL transformed from follicular lymphoma and double-triple hit lymphoma) 4. 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 5. ECOG performance status that is either 0 or 1 at screening 6. 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 7. Adequate organ function 8. Must have a leukapheresis material of non-mobilized cells available for manufacturing Exclusion Criteria: 1. Prior treatment with anti-CD19 therapy, adoptive T cell therapy, or any prior gene therapy product 2. 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. 3. Eligible for and consenting to autologous HSCT 4. Prior allogeneic SCT 5. 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 6. Active neurological autoimmune or inflammatory disorders (e.g. Guillain-Barre syndrome) 7. Investigational medicinal product within the last 30 days or five half-lives (whichever is longer) prior to screening

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Response Rate (ORR) Complete Response (CR) and Partial Response (PR) according to the Lugano classification as determined by the Investigator. From first dosing (single administration, Day 1) up to End of Study Visit (EOS), an average of 60 Months
Secondary Duration of Response (DOR) Time from CR or PR, whichever occurs first, to relapse or death due to DLBCL. From first dosing (single administration, Day 1) up to End of Study Visit (EOS), an average of 60 Months
Secondary Time to response (TTR) Time from tisagenlecleucel infusion to CR or PR, whichever occurs first. From first dosing (single administration, Day 1) up to End of Study Visit (EOS), an average of 60 Months
Secondary Progression-Free Survival (PFS) Time from tisagenlecleucel infusion to the first documented disease progression or death due to any cause. From first dosing (single administration, Day 1) up to End of Study Visit (EOS), an average of 60 Months
Secondary Event free survival (EFS) Time from tisagenlecleucel infusion to the first documented disease progression or relapse, new treatment for lymphoma or death due to any cause. From first dosing (single administration, Day 1) up to End of Study Visit (EOS), an average of 60 Months
Secondary Overall Survival (OS) Time from tisagenlecleucel infusion to death due to any cause. From first dosing (single administration, Day 1) up to End of Study Visit (EOS), an average of 60 Months
Secondary Number of Participants with On-Treatments Adverse Events, Serious Adverse Events, and Deaths Analysis of absolute and relative frequencies for treatment emergent AE, SAE and Deaths by primary System Organ Class (SOC) through the monitoring of relevant clinical and laboratory safety parameters. From first dosing (single administration, Day 1) up to End of Study Visit (EOS), an average of 60 Months
Secondary Tisagenlecleucel immunogenicity (humoral) The humoral immunogenicity assay will be evaluated to measure the antibody titers specific to the tisagenlecleucel molecule prior to and following infusion. Up to Month 60
Secondary Tisagenlecleucel immunogenicity (cellular) The cellular immunogenicity assay will be evaluated to assess the presence of T lymphocytes activated by the tisagenlecleucel protein. Up to Month 60
Secondary In vivo cellular PK profile of tisagenelecleucel qPCR and flow cytometry to measure tisagenlecleucel transgene concentration in blood, bone marrow and other matrices/tissues. Up to Month 60
Secondary Concentration of Tocilizumab PK in tocilizumab treated subjects during CRS Concentration of Tocilizumab Up to Day 7 after tocilizumab infusion
Secondary Serum cytokines (IL-10, interferon gamma, IL-6, CRP and ferritin) Concentration of soluble factors (IL-10, interferon gamma, IL-6, CRP and ferritin) will be listed and summarized by participant and time point. Up to Month 60
See also
  Status Clinical Trial Phase
Recruiting NCT06043011 - Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms
Not yet recruiting NCT05532761 - Multidimensional Assessment of Quality of Life, Social and Professional Life and Care Utilization in Patients With Diffuse Large Cell B-cell Lymphoma Treated With CAR-T Cells
Not yet recruiting NCT05596097 - Zanubrutinib in Maintenance Therapy of DLBCL Patients With Initial Remission Phase 2
Terminated NCT02914938 - A Study of ME-401 in Subjects With CLL/SLL, FL, and B-cell Non Hodgkin's Lymphoma Phase 1
Active, not recruiting NCT02570542 - Study of the Impact of CD34+ Cell Dose on Absolute Lymphocyte Count Following High-Dose Therapy and Autologous Stem Cell Transplantation for Relapsed and Refractory Diffuse Large B-cell Lymphoma (DLBCL) Phase 2
Terminated NCT00482053 - Phase 2 Poor Risk DLBCL of TLI and ATG Followed by Matched Allogeneic HT as Consolidation to Autologous HCT Phase 2
Active, not recruiting NCT04049513 - ENABLE (Engaging Toll-like Receptor Signalling for B-cell Lymphoma Chimeric Antigen Receptor Therapy) Phase 1
Recruiting NCT05364424 - A Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Glofitamab in Combination With Rituximab Plus Ifosfamide, Carboplatin Etoposide Phosphate in Participants With Relapsed/Refractory Transplant or CAR-T Therapy Eligible Diffuse B-Cell Lymphoma Phase 1
Terminated NCT02983097 - Therapy of Non-Hodgkin-Lymphoma by Combination of Lenalidomide + Rituximab, Dexa, High-dose ARA-C and CisP Phase 1/Phase 2
Completed NCT00001337 - Dose-Adjusted EPOCH Chemotherapy and Rituximab (CD20+) in Previously Untreated Aggressive Non-Hodgkin's Lymphoma Phase 2
Active, not recruiting NCT04830137 - A Study of NX-2127 in Adults With Relapsed/Refractory B-cell Malignancies Phase 1
Recruiting NCT03547115 - A Study of Voruciclib Alone or in Combination With Venetoclax in Subjects With B-Cell Malignancies or AML Phase 1
Completed NCT04933617 - Copanlisib With Dose-Adjusted EPOCH-R in Relapsed and Refractory Burkitt Lymphoma and Other High-Grade B-cell Lymphomas Phase 1
Not yet recruiting NCT04767308 - Safety and Efficacy of CT125A Cells for Treatment of Relapsed/Refractory CD5+ Hematopoietic Malignancies Early Phase 1
Recruiting NCT04836507 - Study of Efficacy and Safety of CRC01 in Adult Large B-cell Lymphoma Patients Phase 1/Phase 2
Recruiting NCT05583149 - Acalabrutinib + Liso-Cel In R/R Aggressive B-Cell Lymphomas Phase 2
Terminated NCT02957019 - A Phase I/II Study of the Tumor-targeting Human L19-IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With Rituximab in Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) Phase 1/Phase 2
Completed NCT02445248 - Study of Efficacy and Safety of CTL019 in Adult DLBCL Patients Phase 2
Recruiting NCT06256484 - A Study to Evaluate the Safety and Preliminary Efficacy of ATA3219 in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma Phase 1
Enrolling by invitation NCT04488354 - Long-term Follow-up Study for Patients Treated With CLBR001 CAR-T Phase 1