Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| JEP-2021-224 | Other Identifier | Research Ethics Committee Universiti Kebangsaan Malaysia (REC UKM) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Plutonet Sdn Bhd | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
A Phase II Open-Label Single-arm Study to Evaluate Safety and Efficacy of locally manufactured autologous CD19-directed CAR T-cells in Patients with Relapsed/Refractory B- Non-Hodgkin Lymphoma (B-NHL) or patients not eligible for hematopoietic stem cell transplantation (HCT)
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient will infuse with autologous CD19 CAR-T cells | Experimental | CD19 CAR-T cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAR-T cells | Drug | 2×10^6 CAR T cells/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | The ORR is the sum of patients achieving complete response (CR) and partial response (PR) at day 30, then 3 monthly up to 24 months after receiving CAR T-cells determined by the investigator following Lugano criteria in non-Hodgkin Lymphoma (NHL). Response assessment will be determined using a PET CT scan, or other relevant imaging studies and compared to the baseline (pre-CAR-T infusion) study. | From day 30, then 3 monthly until 24 months after infusion of CAR-T cells |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | Overall survival (OS) is defined as the time from the date of CAR-T cell infusion to the date of death from any cause. Patients who are still alive will be censored at the date of last contact. | OS at day 30, 6 months and one year, and 2 years following CAR-T cells infusion |
| Incidence of adverse events |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| S Fadilah Abdul Wahid Dr. | Contact | +60391456450 | sfadilah@hctm.ukm.edu.my |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universiti Kebangsaan Malaysia | Recruiting | Bandar Tun Razak | Kuala Lumpur | Malaysia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Cumulative incidence of CAR-T cell treatment-related adverse events (AEs) graded by ASCT consensus grading criteria for cytokine release syndrome (CRS) and Immune Effector cell-associated Neurotoxicity Syndrome (ICANS) and by common terminology criteria adverse events (CTCAE) versions 5.0 for other AEs in p[articular hematotoxicity and infection.](streamdown:incomplete-link) |
| From the time of infusion up to 24 months after infusion of CAR-T cells |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D016219 | Immunotherapy, Adoptive |
| ID | Term |
|---|---|
| D019264 | Adoptive Transfer |
| D007116 | Immunization, Passive |
| D007114 | Immunization |
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
Not provided
Not provided