B-cell Non Hodgkin Lymphoma
Conditions
Brief summary
This is a Phase 1, open-label, multi-center study to evaluate the safety of JMT601 in the treatment of relapsed or refractory CD20-positive B-cell non-Hodgkin lymphoma and to determine the recommended dose for Phase 2 studies (RP2D). Study consists of 2 parts. The first part is a dose-escalation part using a 3+3 design with up to 6 dose(0.3 mg/kg, 1 mg/kg, 3 mg/kg, 6 mg/kg, 12 mg/kg and 20 mg/kg) escalation cohorts at increasing levels. The second part is a dose-expansion part at R2PD dose to assess preliminary efficacy of JMT601.
Interventions
BIOLOGICALJMT601
intravenous infusion on day 1 once a week
Sponsors
Shanghai JMT-Bio Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Participants diagnosed with CD20-positive B-cell non-Hodgkin lymphoma confirmed by histopathology and/or cell biology who have previously received 2 or more lines of therapy * Eastern Cooperative Oncology Group (ECOG) physical state score: 0-2 * Participants must have at least one evaluable or measurable lesion according to Lugano 2014 criteria. * Expected survival of at least 3 months; * Suitable organ and hematopoietic function: 1. The absolute count of neutrophil (ANC) ≥1.0×109/L; 2. Platelets ≥75×10\^9/L (if bone marrow invasion doesn't exist)/≥50.0×10\^9/L (if bone marrow invasion exists); 3. Hemoglobin ≥90 g/L; 4. Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min; 5. Total bilirubin ≤1.5×ULN, alanine aminotransferase ≤2.5×ULN, aspartate aminotransferase ≤2.5×ULN; Subjects with liver lesion: TBIL≤3×ULN, ALT≤5×ULN, AST≤5×ULN; 6. International Standardized ratio and activated partial thromboplastin time ≤1.5 × ULN; Key
Exclusion criteria
* Confirmed central nervous system (CNS) lymphoma. * Subjects who have received allogeneic hematopoietic stem cell transplantation (HSCT) or other organ transplantation * Those who have previously received targeted CD47 or signal regulatory protein α (SIRRP α) therapy. * Previous or current hemolytic anemia, Evans syndrome, arteritis; * Subjects with previous or current other malignant tumors; * Previous or current history of active autoimmune diseases; * Subjects who had undergone major surgery within 4 weeks prior to initial dosing or expected to have major surgery during the study period; * HIV infection, active syphilis, hepatitis B surface antigen (HBsAg) positive and HBV-DNA higher than the lower limit or 1000 copies /ml(500 IU/ml), HCV antibody positive and HCV-RNA higher than the lower limit or 1000 copies /ml
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity(DLT) and maximum tolerated dose(MTD) | DLTs and MTD: Up to 28 days after the first dose |
| Incidence of treatment-emergent adverse events (TEAEs) | TEAEs: Up to 90 days after last dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) | Up to 12 months | Defined as the time from initiation of treatment to progression disease or death |
| Overall survival (OS) | Up to 12 months | Defined as the time from initiation of treatment to death of any cause |
| Aera under the curve from 0 to the last measurable concentration(AUClast) | Up to 12 months | Aera under the curve from 0 to the last measurable concentration |
| Aera under the curve from 0 to the infinite time(AUC0-∞) | Up to 12 months | Aera under the curve from 0 to the infinite time |
| Time to maximum concentration(Tmax) | Up to 12 months | time to maximum concentration |
| Overall response rate (ORR) | Up to 12 months | Defined as the proportion of participants with complete response or partial response measured by Lugano 2014 |
| Clearance(CL) | Up to 12 months | clearance |
| Volume(Vd) | Up to 12 months | volume |
| Maximum concentration( Cmax) | Up to 12 months | maximum concentration |
| Minimum concentration(Cmin) | Up to 12 months | minimum concentration |
| Accumulation ratio(AR) | Up to 12 months | accumulation ratio |
| Terminal phase half-life(T1/2) | Up to 12 months | terminal phase half-life |
| Duration of response (DOR) | Up to 12 months | Defined as the time from complete response or partial response to progression disease or death |
Countries
China
Contacts
Primary ContactQingjie Li
Outcome results
None listed