Antibody Information
General Information of This Antibody
| Antibody ID | ANI0OCCUD |
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| Antibody Name | Coltuximab |
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| Organization | ImmunoGen, Inc. |
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| Indication | Diffuse large B-cell lymphoma |
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| Synonyms |
huB4
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| Antibody Type | Monoclonal antibody (mAb) |
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| Antibody Subtype | Chimeric IgG1-kappa |
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| Antigen Name | B-lymphocyte antigen CD19 (CD19) |
Antigen Info | ||||
| ChEMBI ID | ||||||
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| Click to Show/Hide the Sequence Information of This Antibody | ||||||
| Heavy Chain Sequence |
QVQLVQPGAEVVKPGASVKLSCKTSGYTFTSNWMHWVKQAPGQGLEWIGEIDPSDSYTNY
NQNFQGKAKLTVDKSTSTAYMEVSSLRSDDTAVYYCARGSNPYYYAMDYWGQGTSVTVSS ASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSS GLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGG PSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYN STYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDE LTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRW QQGNVFSCSVMHEALHNHYTQKSLSLSPGK Click to Show/Hide
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| Light Chain Sequence |
EIVLTQSPAIMSASPGERVTMTCSASSGVNYMHWYQQKPGTSPRRWIYDTSKLASGVPAR
FSGSGSGTDYSLTISSMEPEDAATYYCHQRGSYTFGGGTKLEIKRTVAAPSVFIFPPSDE QLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSK ADYEKHKVYACEVTHQGLSSPVTKSFNRGEC Click to Show/Hide
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Each Antibody-drug Conjugate Related to This Antibody
Full Information of The Activity Data of The ADC(s) Related to This Antibody
Coltuximab ravtansine [Phase 2 (discontinued)]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | stable disease (SD) |
17.10%
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| Patients Enrolled |
Eligible patients must have confirmed CD19+ DLBCL (de novo/transformed, >30% expression via recent biopsy) with ≥1 prior rituximab-containing regimen and relapsed/refractory status (post-1L ineligible for transplant or post-2L including ASCT). Exclusions cover primary refractory cases and mediastinal DLBCL. Archived FFPE tissue (≤6 months old) or fresh FNA is mandatory for eligibility assessment.
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| Administration Dosage |
All patients will receive SAR3419 until evidence of disease progression, unacceptable toxicity, or other reasons for therapy discontinuation
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| Related Clinical Trial | |||||
| NCT Number | NCT01472887 | Clinical Status | PHASE2 | ||
| Clinical Description |
An Open Label Non-Randomized Phase 2 Study Evaluating SAR3419, an Anti-CD19 Antibody - Maytansine Conjugate, Administered as Single Agent by Intravenous Infusion to Patients With Relapsed or Refractory CD19+ Diffuse Large B-Cell Lymphoma
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| Primary Endpoint |
The primary outcome is the number of participants achieving Objective Response Rate, measured at 18 months.
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| Other Endpoint |
Secondary measures include AE monitoring (up to 1 year), response duration, PFS, and OS (all assessed up to 18 months post-first infusion of the last patient). Key safety and efficacy parameters will be tracked longitudinally during this period.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Efficacy Data | stable disease (SD) |
43%
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| Patients Enrolled |
Eligible participants must have relapsed/refractory CD19+ B-cell NHL (excluding Burkitt's, lymphoblastic, or CLL) with prior standard treatment failure (including post-transplant cases). Exclusions include CNS involvement, non-measurable disease, ECOG >2, life expectancy <3 months, recent chemo/RT (4 weeks), prior radioimmunotherapy (12 weeks), protein anaphylaxis, HIV/HBV/HCV, organ dysfunction, pregnancy, inadequate contraception, or investigator-assessed safety risks.
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| Administration Dosage |
The q1w study was extended to treat 25 pts with the optimized schedule for 8 to 12 doses.
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| Related Clinical Trial | |||||
| NCT Number | NCT00796731 | Clinical Status | PHASE1 | ||
| Clinical Description |
A Dose-escalation, Safety and Pharmacokinetic Study of SAR3419 Administered as a Single Agent by Intravenous Infusion Once Weekly in Patients With Relapsed/Refractory CD19-positive B-cell Non-Hodgkin's Lymphoma (NHL)
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| Primary Endpoint |
The study will assess the incidence of Dose Limiting Toxicities (DLTs) at each tested dose level, with evaluation conducted within the first 3 weeks of treatment initiation.
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| Other Endpoint |
Cumulative DLTs will be monitored throughout the entire treatment period, along with adverse events, lab abnormalities, tumor response (CR/PR), response duration, and pharmacokinetic parameters, all tracked for the duration of the study.
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| Experiment 3 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | progressive disease (PD) |
39%
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| Patients Enrolled |
Eligible patients must have confirmed CD19+ DLBCL (de novo/transformed, >30% expression via recent biopsy) with ≥1 prior rituximab-containing regimen and relapsed/refractory status (post-1L ineligible for transplant or post-2L including ASCT). Exclusions cover primary refractory cases and mediastinal DLBCL. Archived FFPE tissue (≤6 months old) or fresh FNA is mandatory for eligibility assessment.
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| Administration Dosage |
All patients will receive SAR3419 until evidence of disease progression, unacceptable toxicity, or other reasons for therapy discontinuation
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| Related Clinical Trial | |||||
| NCT Number | NCT01472887 | Clinical Status | PHASE2 | ||
| Clinical Description |
An Open Label Non-Randomized Phase 2 Study Evaluating SAR3419, an Anti-CD19 Antibody - Maytansine Conjugate, Administered as Single Agent by Intravenous Infusion to Patients With Relapsed or Refractory CD19+ Diffuse Large B-Cell Lymphoma
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| Primary Endpoint |
The primary outcome is the number of participants achieving Objective Response Rate, measured at 18 months.
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| Other Endpoint |
Secondary measures include AE monitoring (up to 1 year), response duration, PFS, and OS (all assessed up to 18 months post-first infusion of the last patient). Key safety and efficacy parameters will be tracked longitudinally during this period.
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| Experiment 4 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Partial Response (PR) |
29.30%
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| Patients Enrolled |
Eligible patients must have confirmed CD19+ DLBCL (de novo/transformed, >30% expression via recent biopsy) with ≥1 prior rituximab-containing regimen and relapsed/refractory status (post-1L ineligible for transplant or post-2L including ASCT). Exclusions cover primary refractory cases and mediastinal DLBCL. Archived FFPE tissue (≤6 months old) or fresh FNA is mandatory for eligibility assessment.
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| Administration Dosage |
All patients will receive SAR3419 until evidence of disease progression, unacceptable toxicity, or other reasons for therapy discontinuation
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| Related Clinical Trial | |||||
| NCT Number | NCT01472887 | Clinical Status | PHASE2 | ||
| Clinical Description |
An Open Label Non-Randomized Phase 2 Study Evaluating SAR3419, an Anti-CD19 Antibody - Maytansine Conjugate, Administered as Single Agent by Intravenous Infusion to Patients With Relapsed or Refractory CD19+ Diffuse Large B-Cell Lymphoma
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| Primary Endpoint |
The primary outcome is the number of participants achieving Objective Response Rate, measured at 18 months.
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| Other Endpoint |
Secondary measures include AE monitoring (up to 1 year), response duration, PFS, and OS (all assessed up to 18 months post-first infusion of the last patient). Key safety and efficacy parameters will be tracked longitudinally during this period.
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| Experiment 5 Reporting the Activity Date of This ADC | [3] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
25.50%
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| Patients Enrolled |
Eligible patients must have relapsed/refractory B-cell Acute Lymphoblastic Leukemia (including Burkitt's lymphoma), ≤3 prior salvage therapies, and CD19 positivity. Philadelphia-positive patients failing imatinib mesylate are included. No specific exclusion criteria were stated.
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| Administration Dosage |
A total of 37 patients were enrolled from October 10, 2011 to December 19, 2013. One patient was included but did not receive the study treatment, leaving 36 treated patients in the safety population. Of the 36 patients, 19 were treated in part 1 of the study: 7 at 55 mg/m2; 4 at 70 mg/m2; and 8 at 90 mg/m2. The selected dose was determined as 70 mg/m2 and was used in part 2 of the study. As detailed, the 90-mg/m2 dose was associated with no improvement in ORR and an increased occurrence of AEs. An additional 17 patients were included and treated during part 2 of the study. All patients were expected to receive treatment at 70 mg/m2; however, 2 patients received the reduced dose of 55 mg/m2 owing to infusion-related toxicities.
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| Related Clinical Trial | |||||
| NCT Number | NCT01440179 | Clinical Status | PHASE2 | ||
| Clinical Description |
Phase II Two Stage Finding Run-in Study of SAR3419, An Anti-CD19 Antibody-Maytansine Conjugate, Administered as a Single Agent by Intravenous Infusion in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
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| Primary Endpoint |
The study will assess the number of participants achieving an Objective Response Rate (ORR), with evaluations conducted every 4 to 8 weeks.
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| Other Endpoint |
Safety will be monitored by tracking adverse events over one year, while pharmacokinetic parameters (Cmax, AUC, T1/2, clearance, Vss) will be analyzed for up to 8 months. Minimal Residual Disease (MRD) will also be evaluated every 4 to 8 weeks.
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| Experiment 6 Reporting the Activity Date of This ADC | [4] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
31.10%
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| Patients Enrolled |
Eligibility requires a confirmed DLBCL diagnosis with CD19/CD20 positivity and prior rituximab-containing treatment failure. Exclusion criteria include absence of measurable disease (>1.5x1.5 cm lesion on CT) and other safety considerations per investigator assessment.
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| Administration Dosage |
Patients received four weekly doses of coltuximab ravtansine (55 mg/m2) and rituximab (375 mg/m2) by intravenous infusion from weeks 1-4 followed by 4 biweekly doses on weeks 6, 8, 10 and 12.
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| Related Clinical Trial | |||||
| NCT Number | NCT01470456 | Clinical Status | PHASE2 | ||
| Clinical Description |
An Open Label, Multicenter Phase II Study of Intravenous SAR3419, an Anti-CD19 Antibody-Maytansine Conjugate, in Combination With Rituximab in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphomas
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| Primary Endpoint |
The primary endpoint is the number of participants achieving an Objective Response Rate, assessed at the 18-week mark.
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| Other Endpoint |
Secondary objectives include monitoring adverse events (up to 6 months), response duration, progression-free survival, and overall survival (all tracked up to 24 months post-first infusion of the last enrolled patient).
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| Experiment 7 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
43.90%
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| Patients Enrolled |
Eligible patients must have confirmed CD19+ DLBCL (de novo/transformed, >30% expression via recent biopsy) with ≥1 prior rituximab-containing regimen and relapsed/refractory status (post-1L ineligible for transplant or post-2L including ASCT). Exclusions cover primary refractory cases and mediastinal DLBCL. Archived FFPE tissue (≤6 months old) or fresh FNA is mandatory for eligibility assessment.
Click to Show/Hide
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| Administration Dosage |
All patients will receive SAR3419 until evidence of disease progression, unacceptable toxicity, or other reasons for therapy discontinuation
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| Related Clinical Trial | |||||
| NCT Number | NCT01472887 | Clinical Status | PHASE2 | ||
| Clinical Description |
An Open Label Non-Randomized Phase 2 Study Evaluating SAR3419, an Anti-CD19 Antibody - Maytansine Conjugate, Administered as Single Agent by Intravenous Infusion to Patients With Relapsed or Refractory CD19+ Diffuse Large B-Cell Lymphoma
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| Primary Endpoint |
The primary outcome is the number of participants achieving Objective Response Rate, measured at 18 months.
|
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| Other Endpoint |
Secondary measures include AE monitoring (up to 1 year), response duration, PFS, and OS (all assessed up to 18 months post-first infusion of the last patient). Key safety and efficacy parameters will be tracked longitudinally during this period.
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| Experiment 8 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Complete response (CR) |
14.60%
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| Patients Enrolled |
Eligible patients must have confirmed CD19+ DLBCL (de novo/transformed, >30% expression via recent biopsy) with ≥1 prior rituximab-containing regimen and relapsed/refractory status (post-1L ineligible for transplant or post-2L including ASCT). Exclusions cover primary refractory cases and mediastinal DLBCL. Archived FFPE tissue (≤6 months old) or fresh FNA is mandatory for eligibility assessment.
Click to Show/Hide
|
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| Administration Dosage |
All patients will receive SAR3419 until evidence of disease progression, unacceptable toxicity, or other reasons for therapy discontinuation
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| Related Clinical Trial | |||||
| NCT Number | NCT01472887 | Clinical Status | PHASE2 | ||
| Clinical Description |
An Open Label Non-Randomized Phase 2 Study Evaluating SAR3419, an Anti-CD19 Antibody - Maytansine Conjugate, Administered as Single Agent by Intravenous Infusion to Patients With Relapsed or Refractory CD19+ Diffuse Large B-Cell Lymphoma
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| Primary Endpoint |
The primary outcome is the number of participants achieving Objective Response Rate, measured at 18 months.
|
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| Other Endpoint |
Secondary measures include AE monitoring (up to 1 year), response duration, PFS, and OS (all assessed up to 18 months post-first infusion of the last patient). Key safety and efficacy parameters will be tracked longitudinally during this period.
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| Experiment 9 Reporting the Activity Date of This ADC | [5] | ||||
| Patients Enrolled |
Eligible participants must have relapsed/refractory CD19+ non-Hodgkin's B-cell lymphoma (excluding Burkitt's, lymphoblastic, or CLL) with ECOG 0-2. Exclusions include recent chemotherapy/radiotherapy (4 weeks), prior radioimmunotherapy (12 weeks), protein/maytansinoid intolerance, organ dysfunction, pregnancy, or inadequate contraception. Investigator-assessed high-risk comorbidities also preclude participation.
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| Related Clinical Trial | |||||
| NCT Number | NCT00549185 | Clinical Status | PHASE1 | ||
| Clinical Description |
An Open-label Multi-dose-escalation, Safety and Pharmacokinetic Study of SAR3419 Administered as a Single Agent by Intravenous Infusion Every 3 Weeks in Patients With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma (NHL)
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| Primary Endpoint |
The study evaluates Dose Limiting Toxicities (DLTs) across tested dose levels throughout the entire study period.
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| Other Endpoint |
Tumor response (complete/partial/stable disease) will be assessed per Cheson criteria alongside response duration, while adverse events will be monitored continuously during the study.
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References