Antibody Information
General Information of This Antibody
| Antibody ID | ANTI0JOCZB |
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| Antibody Name | Anti-CD20 antibody |
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| Antigen Name | CD20 |
Antigen Info | ||||
| Click to Show/Hide the Sequence Information of This Antibody | ||||||
Each Antibody-drug Conjugate Related to This Antibody
Full Information of The Activity Data of The ADC(s) Related to This Antibody
TRS005 [Phase 2]
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
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| 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
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| 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.
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TRPH-222 [Phase 1 (discontinued)]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [3] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
46%
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| Patients Enrolled |
Eligible participants must be ≥18 with histologically confirmed relapsed/refractory B-cell NHL (DLBCL, FL, MZL, or MCL), ECOG 0-2. Key exclusions include leukemic lymphoma, double-/triple-hit DLBCL, prior organ transplants, significant neuropathy, cardiovascular disease, or other high-risk comorbidities per investigator assessment.
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| Administration Dosage |
TRPH-222-100 is an open-label, multicenter study comprised of dose-escalation and dose-expansion stages. TRPH-222 was administered IV once every 3 weeks. 22 patients were enrolled in dose-escalating cohorts of TRPH-222 (0.6 mg/kg to 10 mg/kg) from DLBCL, FL, TFL, MCL and MZL histologies, and 10 patients in a dose-expansion cohort (7.5 mg/kg) focusing on DLBCL and FL histologies.
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| Related Clinical Trial | |||||
| NCT Number | NCT03682796 | Clinical Status | PHASE1 | ||
| Clinical Description |
Phase 1, Multicenter, Open-Label Study of the Antibody-Drug Conjugate TRPH-222 in Subjects With Relapsed and/or Refractory B-Cell Lymphoma
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| Primary Endpoint |
The study aims to determine the maximum tolerated dose (MTD) of TRPH-222 over a 21-day timeframe while evaluating safety through adverse events (AEs), serious AEs (SAEs), and treatment-related AEs leading to discontinuation or death.
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| Other Endpoint |
Tumor activity will be assessed via objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and duration of response (DOR) using Lugano criteria in NHL subtypes. Pharmacokinetic analysis (Cmax, AUC, CL, Vd, t½) will be conducted over multiple cycles, alongside anti-drug antibody (ADA) incidence monitoring.
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| Experiment 2 Reporting the Activity Date of This ADC | [3] | ||||
| Efficacy Data | Complete Response Rate (CRR) |
31%
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| Patients Enrolled |
Eligible participants must be ≥18 with histologically confirmed relapsed/refractory B-cell NHL (DLBCL, FL, MZL, or MCL), ECOG 0-2. Key exclusions include leukemic lymphoma, double-/triple-hit DLBCL, prior organ transplants, significant neuropathy, cardiovascular disease, or other high-risk comorbidities per investigator assessment.
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| Administration Dosage |
TRPH-222-100 is an open-label, multicenter study comprised of dose-escalation and dose-expansion stages. TRPH-222 was administered IV once every 3 weeks. 22 patients were enrolled in dose-escalating cohorts of TRPH-222 (0.6 mg/kg to 10 mg/kg) from DLBCL, FL, TFL, MCL and MZL histologies, and 10 patients in a dose-expansion cohort (7.5 mg/kg) focusing on DLBCL and FL histologies.
Click to Show/Hide
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| Related Clinical Trial | |||||
| NCT Number | NCT03682796 | Clinical Status | PHASE1 | ||
| Clinical Description |
Phase 1, Multicenter, Open-Label Study of the Antibody-Drug Conjugate TRPH-222 in Subjects With Relapsed and/or Refractory B-Cell Lymphoma
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| Primary Endpoint |
The study aims to determine the maximum tolerated dose (MTD) of TRPH-222 over a 21-day timeframe while evaluating safety through adverse events (AEs), serious AEs (SAEs), and treatment-related AEs leading to discontinuation or death.
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| Other Endpoint |
Tumor activity will be assessed via objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and duration of response (DOR) using Lugano criteria in NHL subtypes. Pharmacokinetic analysis (Cmax, AUC, CL, Vd, t½) will be conducted over multiple cycles, alongside anti-drug antibody (ADA) incidence monitoring.
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| Experiment 3 Reporting the Activity Date of This ADC | [4] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
22.70%
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| Patients Enrolled |
Patients with diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), and marginal zone lymphoma (MZL) were enrolled. Patients had received a median of 4 prior systemic therapy.
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| Administration Dosage |
TRPH-222 was administered IV 0.60 to 5.60 mg/kg once every 3 weeks.
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| Related Clinical Trial | |||||
| NCT Number | NCT03682796 | Clinical Status | Phase 1 | ||
| Clinical Description |
Phase 1, multicenter, open-label study of the antibody-drug conjugate TRPH-222 in subjects with relapsed and/or refractory B-cell lymphoma.
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Discovered Using Cell Line-derived Xenograft Model
| Experiment 1 Reporting the Activity Date of This ADC | [5] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 51% | Positive CD22 expression (CD22+++/++) | ||
| Method Description |
In WSU-DLCL2 xenografts once weekly intravenous (IV) dosing with 1 mg/kg TRPH-222.
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| In Vivo Model | Non-Hodgkin's lymphoma CDX model | ||||
| In Vitro Model | Diffuse large B-cell lymphoma | WSU-DLCL2 cells | CVCL_1902 | ||
| Experiment 2 Reporting the Activity Date of This ADC | [6] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 87% | Positive CD22 expression (CD22+++/++) | ||
| Method Description |
In Granta-519 xenografts,trph-222 was dosed at 10 mg/kg once weekly intravenous (IV).
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| In Vivo Model | Mantle cell lymphoma CDX model | ||||
| In Vitro Model | Mantle cell lymphoma | Granta-519 cells | CVCL_1818 | ||
| Experiment 3 Reporting the Activity Date of This ADC | [6] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 91% | Positive CD22 expression (CD22+++/++) | ||
| Method Description |
In SU-DHL-2 xenografts,trph-222 was dosed at 10 mg/kg once weekly intravenous (IV).
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| In Vivo Model | Diffuse large B cell lymphoma CDX model | ||||
| In Vitro Model | Diffuse large B-cell lymphoma | SU-DHL-2 cells | CVCL_9550 | ||
| Experiment 4 Reporting the Activity Date of This ADC | [6] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 100% | Positive CD22 expression (CD22+++/++) | ||
| Method Description |
In SU-DHL-4 xenografts,trph-222 was dosed at 10 mg/kg once weekly intravenous (IV).
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| In Vivo Model | Diffuse large B cell lymphoma CDX model | ||||
| In Vitro Model | Diffuse large B-cell lymphoma | SU-DHL-4 cells | CVCL_0539 | ||
| Experiment 5 Reporting the Activity Date of This ADC | [6] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 100% | Positive CD22 expression (CD22+++/++) | ||
| Method Description |
In WSU-DLCL2 xenografts once every three-week intravenous (IV) dosing with 10 mg/kg TRPH-222.
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| In Vivo Model | Non-Hodgkin's lymphoma CDX model | ||||
| In Vitro Model | Diffuse large B-cell lymphoma | WSU-DLCL2 cells | CVCL_1902 | ||
| Experiment 6 Reporting the Activity Date of This ADC | [6] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 100% | Positive CD22 expression (CD22+++/++) | ||
| Method Description |
In WSU-DLCL2 xenografts once weekly intravenous (IV) dosing with 10 mg/kg TRPH-222.
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| In Vivo Model | Non-Hodgkin's lymphoma CDX model | ||||
| In Vitro Model | Diffuse large B-cell lymphoma | WSU-DLCL2 cells | CVCL_1902 | ||
| Experiment 7 Reporting the Activity Date of This ADC | [6] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 100% | Positive CD22 expression (CD22+++/++) | ||
| Method Description |
In WSU-DLCL2 xenografts once weekly intravenous (IV) dosing with 3 mg/kg TRPH-222.
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| In Vivo Model | Non-Hodgkin's lymphoma CDX model | ||||
| In Vitro Model | Diffuse large B-cell lymphoma | WSU-DLCL2 cells | CVCL_1902 | ||
References