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
| Indication | Phase 1 | Phase 2 | Phase 3 | Approved | ||
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| Unspecific non-hodgkin lymphoma |
1 Trials
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| Diffuse large B-cell lymphoma |
1 Trials
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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