Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ID: DRG0KMHHU)
| ADC Name |
TRS005
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| Synonyms |
TRS005; Rituximab-MC-vc-MMAE; TRS-005; rituximab-MC-vc-MMAE
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| Organization |
TCRx Therapeutics (Originator)
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| Drug Status |
Phase 2
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| Drug-to-Antibody Ratio |
4.2
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| Structure |
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| Antibody Name |
Anti-CD20 antibody
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Antibody Info | ||||
| Antigen Name |
B-lymphocyte antigen CD20 (MS4A1)
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Antigen Info | ||||
| Payload Name |
Monomethyl auristatin E
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Payload Info | ||||
| Payload Target |
Microtubule (MT)
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Target Info | ||||
| Linker Name |
Mc-Val-Cit-PABC
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Linker Info | ||||
| Conjugate Type |
Random Cysteines
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| Combination Type |
vedotin
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2027 Update
The disease landscape of This ADC
2027 Update
The clinical trial pipelines of This ADC
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
56.70%
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| Patients Enrolled |
Eligible participants are adults (≥18) with relapsed/refractory CD20+ B-cell NHL (≥2 prior therapies), measurable lesions (≥1.5cm), and adequate organ function. Exclusions include active HBV/HCV/HIV, uncontrolled cardiovascular/autoimmune diseases, recent rituximab/CAR-T therapy, or CNS involvement. Contraception and lab criteria (ANC ≥1.5×10<sup>9</sup>/L, PLT ≥100×10<sup>9</sup>/L, etc.) are mandatory.
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| Administration Dosage |
The dose of the enrolled subjects was increased according to the following 7 dose groups: 0.1mg/kg, 0.5mg/kg, 1.0mg/kg, 1.5mg/kg, 1.8mg/kg, and 2.1mg/kg. (according to the data of the previous study, when the dose climbs to 1.5 mg / kg, there is a serious decline of neutrophils, which shall be subject to the principle of 3 + 3.
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| Related Clinical Trial | |||||
| NCT Number | NCT05395533 | Clinical Status | PHASE1 | ||
| Clinical Description | A Multicenter, Single-arm, Dose-escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Effectiveness of TRS005 in Patients With Relapsed or Refractory CD20-positive B-NHL | ||||
| Primary Endpoint |
The study evaluates dose-limiting toxicities (DLTs) including grade 4 neutropenia unresponsive to G-CSF, grade 4 thrombocytopenia, and grade ≥2 neurotoxicity. The maximum tolerated dose (MTD) will be determined as the highest dose with ≤33% DLT incidence.
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| Other Endpoint |
Immunogenicity (anti-drug antibody/neutralizing antibody), pharmacokinetics (Cmax, AUC0-t, AUC0-∞, Tmax), and efficacy (ORR per CR/PR) will be tracked across treatment cycles (21-day intervals). PK parameters are derived from plasma concentration-time curves.
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| Experiment 2 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Disease control rate (DCR) |
86.70%
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| Patients Enrolled |
Eligible participants are adults (≥18) with relapsed/refractory CD20+ B-cell NHL (≥2 prior therapies), measurable lesions (≥1.5cm), and adequate organ function. Exclusions include active HBV/HCV/HIV, uncontrolled cardiovascular/autoimmune diseases, recent rituximab/CAR-T therapy, or CNS involvement. Contraception and lab criteria (ANC ≥1.5×10<sup>9</sup>/L, PLT ≥100×10<sup>9</sup>/L, etc.) are mandatory.
Click to Show/Hide
|
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| Administration Dosage |
The dose of the enrolled subjects was increased according to the following 7 dose groups: 0.1mg/kg, 0.5mg/kg, 1.0mg/kg, 1.5mg/kg, 1.8mg/kg, and 2.1mg/kg. (according to the data of the previous study, when the dose climbs to 1.5 mg / kg, there is a serious decline of neutrophils, which shall be subject to the principle of 3 + 3.
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| Related Clinical Trial | |||||
| NCT Number | NCT05395533 | Clinical Status | PHASE1 | ||
| Clinical Description | A Multicenter, Single-arm, Dose-escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Effectiveness of TRS005 in Patients With Relapsed or Refractory CD20-positive B-NHL | ||||
| Primary Endpoint |
The study evaluates dose-limiting toxicities (DLTs) including grade 4 neutropenia unresponsive to G-CSF, grade 4 thrombocytopenia, and grade ≥2 neurotoxicity. The maximum tolerated dose (MTD) will be determined as the highest dose with ≤33% DLT incidence.
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| Other Endpoint |
Immunogenicity (anti-drug antibody/neutralizing antibody), pharmacokinetics (Cmax, AUC0-t, AUC0-∞, Tmax), and efficacy (ORR per CR/PR) will be tracked across treatment cycles (21-day intervals). PK parameters are derived from plasma concentration-time curves.
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| Experiment 3 Reporting the Activity Date of This ADC | [2] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
42.20
52.90 26.30 60.00 66.70 0.00 42.90 33.30 43.80 50.00 % |
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| Patients Enrolled |
CD20-positive B-cell non Hodgkin lymphoma (NHL) and had failed 2 prior lines of standard treatment.
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| Administration Dosage |
Seven dose cohorts (0.10, 0.50, 1.00, 1.50, 1.80, 2.10, 2.30 mg/kg iv d1,q21d).
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| Related Clinical Trial | |||||
| NCT Number | NCT05395533 | Clinical Status | Phase 1 | ||
| Clinical Description | A multicenter, single-arm, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics and effectiveness of TRS005 in patients with relapsed or refractory CD20-positive B-NHL. | ||||
References