Phase 2
Completed N=80
A Study of CS1001 in Subjects With Relapsed or Refractory Extranodal Natural Killer/ T Cell Lymphoma(ENKTL)
Source: ClinicalTrials.gov NCT03595657 ↗Enrolled (actual)
80
Serious AEs
27.5%
Results posted
Jun 2024
Primary outcomePrimary: Objective Response Rate (ORR) Assessed by IRRC — 46.2 percentage of Participants
Summary
This is a multicenter, single-arm, phase II study to evaluate the efficacy and safety of CS1001 monotherapy for Relapsed or Refractory Extranodal Natural Killer/ T Cell Lymphoma (ENKTL)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) Assessed by IRRC |
46.2 | — |
| SECONDARY Objective Response Rate (ORR) Assessed by Investigators |
45.6 | — |
| SECONDARY Complete Response Rate (CRR) by Investigators |
30.4 | — |
| SECONDARY Complete Response Rate (CRR) Assessed by IRRC |
37.2 | — |
| SECONDARY Partial Response Rate (PRR) Assessed by Investigators |
15.2 | — |
| SECONDARY Partial Response Rate (PRR) Assessed by IRRC |
9.0 | — |
| SECONDARY Duration of Response (DoR) Assessed by Investigators |
39.9 | — |
| SECONDARY Duration of Response (DoR) Assessed by IRRC |
35.2 | — |
| SECONDARY Time to Response (TTR) Assessed by Investigators |
2.8 | — |
| SECONDARY Time to Response (TTR) Assessed by IRRC |
2.8 | — |
| SECONDARY Number of Participants With Adverse Events |
77; 63; 22; 8; 37; 15 | — |
Eligibility Criteria
Inclusion Criteria
- Subject must have a histologically confirmed NKTL at study site.
- Subject must have relapsed or refractory NKTL after prior asparaginase-based chemotherapy or chemo radiotherapy.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Subject must have at least one evaluable or measurable lesion per Lugano 2014 classification.
- Subject must have adequate organ function and bone marrow function without severe hematopoietic disorder, or heart, lung, liver or kidney dysfunction or immune deficiency.
- Subject must provide stained tumor tissue sections and corresponding pathological report or unstained tumor tissue sections (or tissue block) for central pathology review.
- Subject with prior anti-cancer treatment can only be enrolled when the toxicity of prior anti-cancer treatment has recovered to baseline or ≤ Grade 1 according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03.
Exclusion Criteria
- Invasive natural killer leukemia.
- Concomitant with hemophagocytic syndrome.
- Primary site in central nervous system (CNS) or CNS involvement.
- Subjects currently participating in other clinical studies or use of any investigational drug within 4 weeks prior to the first dose of CS1001.
- Subjects who received systemic corticosteroid or any other immunosuppressive therapy within 14 days prior to the first dose of CS1001.
- Subjects who had prior chemotherapy, immune therapy, biological therapy as systemic treatment for cancer, within 28 days prior to the first dose of CS1001.
- Receipt of traditional medicinal herbal preparations with anti-tumor indications with 7 days prior to the first dose of CS1001.
- Known history of human immunodeficiency virus (HIV) infection and/or acquired immune deficiency syndrome.
- Subjects with active hepatitis B or C infection.
- Subjects with active tuberculosis infection.
- Subjects who received prior therapy with anti-PD-1, anti-PD-L1 or anti-CTLA-4 monoclonal antibody.
- Female subjects who are pregnant or breast-feeding.
For more information regarding trial participation, please contact at [email protected]
Data sourced from ClinicalTrials.gov (NCT03595657). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.