Clinical trial NCT06725524: A Study of JMT601 in Participants With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin Lymphoma
Official title: A Phase 1, Open-Label, Multi-center Study Evaluating the Safety and Tolerability of of JMT601 in Participants With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: B-cell Non Hodgkin Lymphoma
Lead sponsor: Shanghai JMT-Bio Inc.
Sponsor class: INDUSTRY
First posted: 2024-12-10
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Dose-limiting toxicity(DLT) and maximum tolerated dose(MTD)
timeFrame: DLTs and MTD: Up to 28 days after the first dose
measure: Incidence of treatment-emergent adverse events (TEAEs)
timeFrame: TEAEs: Up to 90 days after last dose
Secondary outcomes:
measure: Overall response rate (ORR)
timeFrame: Up to 12 months
measure: Duration of response (DOR)
timeFrame: Up to 12 months
measure: Progression free survival (PFS)
timeFrame: Up to 12 months
measure: Overall survival (OS)
timeFrame: Up to 12 months
measure: Aera under the curve from 0 to the last measurable concentration(AUClast)
timeFrame: Up to 12 months
measure: Aera under the curve from 0 to the infinite time(AUC0-∞)
timeFrame: Up to 12 months
measure: Time to maximum concentration(Tmax)
timeFrame: Up to 12 months
measure: Terminal phase half-life(T1/2)
timeFrame: Up to 12 months
measure: Clearance(CL)
timeFrame: Up to 12 months
measure: Volume(Vd)
timeFrame: Up to 12 months
measure: Maximum concentration( Cmax)
timeFrame: Up to 12 months
measure: Minimum concentration(Cmin)
timeFrame: Up to 12 months
measure: Accumulation ratio(AR)
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
Study officials:
affiliation: Ruijin Hospital Clinical, Shanghai Jiao Tong University, School of Medicine
name: Weili Zhao
role: PRINCIPAL_INVESTIGATOR
References: