General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0FUFBP
ADC Name
Camidanlumab tesirine
Synonyms
ADCT-301; Cami; HuMax-TAC-ADC
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Organization
ADC Therapeutics SA
Drug Status
Phase 2
Indication
In total 22 Indication(s)
Hodgkin lymphoma [ICD11:2B30]
Phase 2
Acute lymphoblastic leukemia [ICD11:2B33]
Phase 1
B-cell lymphoma [ICD11:2A86]
Phase 1
Bladder cancer [ICD11:2C94]
Phase 1
Burkitt lymphoma [ICD11:2A85]
Phase 1
Colorectal cancer [ICD11:2B91]
Phase 1
Cutaneous T-cell lymphoma [ICD11:2B00]
Phase 1
Diffuse large B-cell lymphoma [ICD11:2A81]
Phase 1
Esophageal cancer [ICD11:2B70]
Phase 1
Fallopian tube cancer [ICD11:2C74]
Phase 1
Follicular lymphoma [ICD11:2A80]
Phase 1
Gastric cancer [ICD11:2B72]
Phase 1
Head and neck squamous carcinoma [ICD11:2C31]
Phase 1
Macroglobulinemia [ICD11:2A85]
Phase 1
Mantle cell lymphoma [ICD11:2A85]
Phase 1
Melanoma [ICD11:2C30]
Phase 1
Non-small cell lung cancer [ICD11:2C25]
Phase 1
Ovarian cancer [ICD11:2C73]
Phase 1
Pancreatic cancer [ICD11:2C10]
Phase 1
Peripheral T-cell lymphoma [ICD11:2A90]
Phase 1
Renal cell carcinoma [ICD11:2C90]
Phase 1
Acute myeloid leukaemia [ICD11:2A60]
Terminated in phase 1
Drug-to-Antibody Ratio
2.25
Structure
Antibody Name
Camidanlumab
 Antibody Info 
Antigen Name
Interferon-stimulated gene 20 kDa protein (ISG20)
 Antigen Info 
Payload Name
SG3199
 Payload Info 
Therapeutic Target
Human Deoxyribonucleic acid (hDNA)
 Target Info 
Linker Name
Mal-PEG8-Val-Ala-PABC
 Linker Info 
Conjugate Type
Random conjugation through reduced inter-chain cysteines.
Combination Type
SG3249
Puchem SID
472406907 , 381128119 , 404720412 , 384585303
Drugbank ID
DB16411
ChEBI ID
CHEMBL4297871
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 3 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Complete Remission (CR)  NCT02432235
Phase 1
A phase 1 adaptive dose-escalation study to evaluate the tolerability, safety, pharmacokinetics, and antitumor activity of ADCT-301 in patients with relapsed or refractory Hodgkin lymphoma and non-Hodgkin lymphoma.

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Undisclosed  NCT02588092
Phase 1
A phase 1, open-label, dose-escalation, multicenter study to evaluate the tolerability, safety, pharmacokinetics, and activity of ADCT 301 in patients with relapsed or refractory CD25-positive acute myeloid leukemia (AML) or CD25-positive acute lymphoblastic leukemia.

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Undisclosed  NCT02432235
Phase 1
A phase 1 adaptive dose-escalation study to evaluate the tolerability, safety, pharmacokinetics, and antitumor activity of ADCT-301 in patients with relapsed or refractory Hodgkin lymphoma and non-Hodgkin lymphoma.

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Discovered Using Cell Line-derived Xenograft Model
Click To Hide/Show 9 Activity Data Related to This Level
Standard Type Value Units Cell Line Disease Model
Tumor Growth Inhibition value (TGI) 
≈ 11.6
%
Karpas-299 cells
ALK-positive anaplastic large cell lymphoma
Tumor Growth Inhibition value (TGI) 
≈ 41.5
%
SU-DHL-1 cells
Anaplastic large cell lymphoma
Tumor Growth Inhibition value (TGI) 
≈ 51.3
%
SU-DHL-1 cells
Anaplastic large cell lymphoma
Tumor Growth Inhibition value (TGI) 
≈ 68.4
%
Karpas-299 cells
ALK-positive anaplastic large cell lymphoma
Tumor Growth Inhibition value (TGI) 
≈ 93.2
%
Karpas-299 cells
ALK-positive anaplastic large cell lymphoma
Tumor Growth Inhibition value (TGI) 
≈ 94.1
%
SU-DHL-1 cells
Anaplastic large cell lymphoma
Tumor Growth Inhibition value (TGI) 
≈ 97.1
%
Karpas-299 cells
ALK-positive anaplastic large cell lymphoma
Tumor Growth Inhibition value (TGI) 
≈ 98.4
%
Karpas-299 cells
ALK-positive anaplastic large cell lymphoma
Tumor Growth Inhibition value (TGI) 
≈ 98.8
%
SU-DHL-1 cells
Anaplastic large cell lymphoma
Revealed Based on the Cell Line Data
Click To Hide/Show 9 Activity Data Related to This Level
Standard Type Value Units Cell Line Disease Model
Half Maximum Growth Inhibitory Concentration (GI50) 
0.26
pM
EoL-1 cells
Chronic eosinophilic leukemia
Half Maximum Growth Inhibitory Concentration (GI50) 
4.96
pM
SU-DHL-1 cells
Anaplastic large cell lymphoma
Half Maximum Growth Inhibitory Concentration (GI50) 
17.07
pM
Karpas-299 cells
ALK-positive anaplastic large cell lymphoma
Half Maximum Growth Inhibitory Concentration (GI50) 
19.6
pM
HDLM-2 cells
Hodgkin lymphoma
Half Maximum Growth Inhibitory Concentration (GI50) 
> 6667
pM
Ramos cells
Burkitt lymphoma
Half Maximum Growth Inhibitory Concentration (GI50) 
> 6667
pM
Daudi cells
Burkitt lymphoma
Half Maximum Growth Inhibitory Concentration (GI50) 
> 6667
pM
HuT 78 cells
T lymphocytic leukemia
Half Maximum Growth Inhibitory Concentration (GI50) 
> 6667
pM
KG-1 cells
Adult acute myeloid leukemia
Half Maximum Growth Inhibitory Concentration (GI50) 
7.49
1.11
pM
ng/mL
L-540 cells
Hodgkin lymphoma
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 3 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Efficacy Data Complete Remission (CR)
48.60% (In the cHL cohort, at 45 ug/kg)
35.00% (In the cHL cohort, at 30 ug/kg)
6.50% (in all patients with T-NHL)
10.00% (in all patients with T-NHL, 60 ug/kg doses)
7.10% (in all patients with T-NHL, 80 ug/kg doses)
0.00% (in all patients with T-NHL, 100 ug/kg doses)
Patients Enrolled
Relapsed or refractory classical Hodgkin lymphoma or non-Hodgkin lymphoma, an Eastern Cooperative Oncology Group performance status 0-2, who had no therapies available to them with established clinical benefit for their disease stage were enrolled.
Administration Dosage
Intravenously (3-150 ug/kg) once every 3 weeks.
Related Clinical Trial
NCT Number NCT02432235  Clinical Status Phase 1
Clinical Description A phase 1 adaptive dose-escalation study to evaluate the tolerability, safety, pharmacokinetics, and antitumor activity of ADCT-301 in patients with relapsed or refractory Hodgkin lymphoma and non-Hodgkin lymphoma.
Primary Endpoint
The maximum tolerated dose was not reached. The recommended doses for expansion were 30 ug/kg and 45 ug/kg for patients with classical Hodgkin lymphoma and 80 ug/kg for patients with T-cell non-Hodgkin lymphomas. No recommended doses for expansion were defined for B-cell non-Hodgkin lymphomas.
Other Endpoint
In the cHL cohort,ORR (95% CI) was 86.49% at 45 ug/kg (32/37 patients [71.20-95.50]) and 55.00% at 30 ug/kg (11/20 patients [31.50-76.90]); 48.65% (18/37 patients) and 35.00% (7/20 patients) achieved CR. Median (95% CI) DOR for the cHL population was 6.64 months (5.06-8.11),and was 7.16 months (4.57-8.51) in patients treated at 45 ug/kg.
Experiment 2 Reporting the Activity Date of This ADC [2]
Patients Enrolled
Antecedent myelodysplastic syndrome who received treatment with hypomethylating agents and subsequently presented with CD25-positive AmL, or patients with R/R CD25-positive acute lymphocytic leukemia (ALL) who had failed or were intolerant to any established therapy, or for whom no other treatment options were available.
Administration Dosage
Intravenously at 3-92 ug/kg once every three weeks (Q3W) or 30 or 37.50 ug/kg every week (QW).
Related Clinical Trial
NCT Number NCT02588092  Clinical Status Phase 1
Clinical Description A phase 1, open-label, dose-escalation, multicenter study to evaluate the tolerability, safety, pharmacokinetics, and activity of ADCT 301 in patients with relapsed or refractory CD25-positive acute myeloid leukemia (AML) or CD25-positive acute lymphoblastic leukemia.
Primary Endpoint
Two patients achieved complete responses with incomplete hematologic recovery; one each at 30.00 and 37.50 ug/kg QW.
Other Endpoint
Of 16 patients with post-baseline disease assessments, two patients treated on the QW dosing regimen had a complete response (CR).
Experiment 3 Reporting the Activity Date of This ADC [3]
Patients Enrolled
Relapsed or refractory classical Hodgkin lymphoma and non-Hodgkin lymphoma.
Administration Dosage
45 ug/kg Q3W for 2 cycles and then 30 ug/kg Q3W thereafter; intravenous administration.
Related Clinical Trial
NCT Number NCT02432235  Clinical Status Phase 1
Clinical Description A phase 1 adaptive dose-escalation study to evaluate the tolerability, safety, pharmacokinetics, and antitumor activity of ADCT-301 in patients with relapsed or refractory Hodgkin lymphoma and non-Hodgkin lymphoma.
Primary Endpoint
The ORR was 40%,representing 51 responders (patients achieved a best overall response of confirmed PR).
Other Endpoint
Of the 130 patients included in the safety analysis, 27 (20.77%) experienced grade2 increased GGT, 17 (13.08%) experienced a grade2 neurologic AE,and 18 (13.85%) experienced a grade2 autoimmune AE at cycle 6.
Discovered Using Cell Line-derived Xenograft Model
Click To Hide/Show 9 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [4]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 11.60% (Day 21) Moderate CD25 expression (CD25++; 76,000 CD25 molecules/cell)
Method Description
Camidanlumab tesirine induces efficient tumor cell killing in CDX models of an anaplastic large cell lymphoma (ALCL) cell line Karpas 299 with moderate CD25 expression (molecules per cell surface=76000). Compared with injection of vehicle (PBS), ADCT-301 administered intravenously (i.v.) at a mean tumor volume of 160 mm3 as a single dose at 0.1 mg/kg.

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In Vivo Model Anaplastic large cell lymphoma CDX model
In Vitro Model ALK-positive anaplastic large cell lymphoma Karpas-299 cells CVCL_1324
Experiment 2 Reporting the Activity Date of This ADC [4]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 41.50% (Day 32) High CD25 expression (CD25+++; 310,000 CD25 molecules/cell)
Method Description
Camidanlumab tesirine induces efficient tumor cell killing in CDX models of an anaplastic large cell lymphoma (ALCL) cell line Su-DHL-1 with high CD25 expression (molecules per cell surface=310000).ADCT-301 was administered intravenously at mean tumor volume of 155 mm3 at single doses of 0.3 mg/kg and tumor growth compared with that observed after injection of vehicle (PBS).

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In Vivo Model Anaplastic large cell lymphoma CDX model
In Vitro Model Anaplastic large cell lymphoma SU-DHL-1 cells CVCL_0538
Experiment 3 Reporting the Activity Date of This ADC [4]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 51.30% (Day 21) High CD25 expression (CD25+++; 310,000 CD25 molecules/cell)
Method Description
Camidanlumab tesirine induces efficient tumor cell killing in CDX models of an anaplastic large cell lymphoma (ALCL) cell line Su-DHL-1 with high CD25 expression (molecules per cell surface=310000).ADCT-301 was administered intravenously at mean tumor volume of 155 mm3 at single doses of 0.3 mg/kg and tumor growth compared with that observed after injection of vehicle (PBS).

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In Vivo Model Anaplastic large cell lymphoma CDX model
In Vitro Model Anaplastic large cell lymphoma SU-DHL-1 cells CVCL_0538
Experiment 4 Reporting the Activity Date of This ADC [4]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 68.40% (Day 21) Moderate CD25 expression (CD25++; 76,000 CD25 molecules/cell)
Method Description
Camidanlumab tesirine induces efficient tumor cell killing in CDX models of an anaplastic large cell lymphoma (ALCL) cell line Karpas 299 with moderate CD25 expression (molecules per cell surface=76000). Compared with injection of vehicle (PBS), ADCT-301 administered intravenously (i.v.) at a mean tumor volume of 160 mm3 as a single dose at 0.2 mg/kg.

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In Vivo Model Anaplastic large cell lymphoma CDX model
In Vitro Model ALK-positive anaplastic large cell lymphoma Karpas-299 cells CVCL_1324
Experiment 5 Reporting the Activity Date of This ADC [4]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 93.20% (Day 21) Moderate CD25 expression (CD25++; 76,000 CD25 molecules/cell)
Method Description
Camidanlumab tesirine induces efficient tumor cell killing in CDX models of an anaplastic large cell lymphoma (ALCL) cell line Karpas 299 with moderate CD25 expression (molecules per cell surface=76000). Compared with injection of vehicle (PBS), ADCT-301 administered intravenously (i.v.) at a mean tumor volume of 160 mm3 as a single dose at 0.4 mg/kg.

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In Vivo Model Anaplastic large cell lymphoma CDX model
In Vitro Model ALK-positive anaplastic large cell lymphoma Karpas-299 cells CVCL_1324
Experiment 6 Reporting the Activity Date of This ADC [4]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 94.10% (Day 32) High CD25 expression (CD25+++; 310,000 CD25 molecules/cell)
Method Description
Camidanlumab tesirine induces efficient tumor cell killing in CDX models of an anaplastic large cell lymphoma (ALCL) cell line Su-DHL-1 with high CD25 expression (molecules per cell surface=310000).ADCT-301 was administered intravenously at mean tumor volume of 155 mm3 at single doses of 0.6 mg/kg and tumor growth compared with that observed after injection of vehicle (PBS).

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In Vivo Model Anaplastic large cell lymphoma CDX model
In Vitro Model Anaplastic large cell lymphoma SU-DHL-1 cells CVCL_0538
Experiment 7 Reporting the Activity Date of This ADC [4]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 97.10% (Day 21) Moderate CD25 expression (CD25++; 76,000 CD25 molecules/cell)
Method Description
Camidanlumab tesirine induces efficient tumor cell killing in CDX models of an anaplastic large cell lymphoma (ALCL) cell line Karpas 299 with moderate CD25 expression (molecules per cell surface=76000).Vechicle (PBS), ADCT-301 (dar 2.2), nonbinding ADC (DAR 2.1) or Adcetris (DAR~4) were administered intravenously at a mean Karpas 299 tumor volume of 130mm3 as single doses at 0.5 mg/kg.

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In Vivo Model Anaplastic large cell lymphoma CDX model
In Vitro Model ALK-positive anaplastic large cell lymphoma Karpas-299 cells CVCL_1324
Experiment 8 Reporting the Activity Date of This ADC [4]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 98.40% (Day 21) Moderate CD25 expression (CD25++; 76,000 CD25 molecules/cell)
Method Description
Camidanlumab tesirine induces efficient tumor cell killing in CDX models of an anaplastic large cell lymphoma (ALCL) cell line Karpas 299 with moderate CD25 expression (molecules per cell surface=76000). Compared with injection of vehicle (PBS), ADCT-301 administered intravenously (i.v.) at a mean tumor volume of 160 mm3 as a single dose at 0.6mg/kg.

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In Vivo Model Anaplastic large cell lymphoma CDX model
In Vitro Model ALK-positive anaplastic large cell lymphoma Karpas-299 cells CVCL_1324
Experiment 9 Reporting the Activity Date of This ADC [4]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 98.80% (Day 21) High CD25 expression (CD25+++; 310,000 CD25 molecules/cell)
Method Description
Camidanlumab tesirine induces efficient tumor cell killing in CDX models of an anaplastic large cell lymphoma (ALCL) cell line Su-DHL-1 with high CD25 expression (molecules per cell surface=310000).ADCT-301 was administered intravenously at mean tumor volume of 155 mm3 at single doses of 0.6 mg/kg and tumor growth compared with that observed after injection of vehicle (PBS).

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In Vivo Model Anaplastic large cell lymphoma CDX model
In Vitro Model Anaplastic large cell lymphoma SU-DHL-1 cells CVCL_0538
Revealed Based on the Cell Line Data
Click To Hide/Show 9 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [4]
Efficacy Data Half Maximum Growth Inhibitory Concentration (GI50) 0.26 pM Moderate CD25 expression (CD25++; 17,000 CD25 molecules/cell)
Method Description
The inhibitory activity of ADCT-301 against cancer cell growth was evaluated in various human cancer cell lines in vitro. CD25-positive and -negative cell lines were incubated with increasing concentrations of ADCT-301 or free warhead (SG3199) for 96 hours before processing by the MTS assay.
In Vitro Model Chronic eosinophilic leukemia EoL-1 cells CVCL_0258
Experiment 2 Reporting the Activity Date of This ADC [4]
Efficacy Data Half Maximum Growth Inhibitory Concentration (GI50) 4.96 pM High CD25 expression (CD25+++; 310,000 CD25 molecules/cell)
Method Description
The inhibitory activity of ADCT-301 against cancer cell growth was evaluated in various human cancer cell lines in vitro. CD25-positive and -negative cell lines were incubated with increasing concentrations of ADCT-301 or free warhead (SG3199) for 96 hours before processing by the MTS assay.
In Vitro Model Anaplastic large cell lymphoma SU-DHL-1 cells CVCL_0538
Experiment 3 Reporting the Activity Date of This ADC [4]
Efficacy Data Half Maximum Growth Inhibitory Concentration (GI50) 17.07 pM Moderate CD25 expression (CD25++; 76,000 CD25 molecules/cell)
Method Description
The inhibitory activity of ADCT-301 against cancer cell growth was evaluated in various human cancer cell lines in vitro. CD25-positive and -negative cell lines were incubated with increasing concentrations of ADCT-301 or free warhead (SG3199) for 96 hours before processing by the MTS assay.
In Vitro Model ALK-positive anaplastic large cell lymphoma Karpas-299 cells CVCL_1324
Experiment 4 Reporting the Activity Date of This ADC [4]
Efficacy Data Half Maximum Growth Inhibitory Concentration (GI50) 19.60 pM High CD25 expression (CD25+++; 167,000 CD25 molecules/cell)
Method Description
The inhibitory activity of ADCT-301 against cancer cell growth was evaluated in various human cancer cell lines in vitro. CD25-positive and -negative cell lines were incubated with increasing concentrations of ADCT-301 or free warhead (SG3199) for 96 hours before processing by the MTS assay.
In Vitro Model Hodgkin lymphoma HDLM-2 cells CVCL_0009
Experiment 5 Reporting the Activity Date of This ADC [4]
Efficacy Data Half Maximum Growth Inhibitory Concentration (GI50) > 6667.00 pM Negative CD25 expression (CD25-; <1,000 CD25 molecules/cell)
Method Description
The inhibitory activity of ADCT-301 against cancer cell growth was evaluated in various human cancer cell lines in vitro. CD25-positive and -negative cell lines were incubated with increasing concentrations of ADCT-301 or free warhead (SG3199) for 96 hours before processing by the MTS assay.
In Vitro Model Burkitt lymphoma Ramos cells CVCL_0597
Experiment 6 Reporting the Activity Date of This ADC [4]
Efficacy Data Half Maximum Growth Inhibitory Concentration (GI50) > 6667.00 pM Negative CD25 expression (CD25-; <1,000 CD25 molecules/cell)
Method Description
The inhibitory activity of ADCT-301 against cancer cell growth was evaluated in various human cancer cell lines in vitro. CD25-positive and -negative cell lines were incubated with increasing concentrations of ADCT-301 or free warhead (SG3199) for 96 hours before processing by the MTS assay.
In Vitro Model Burkitt lymphoma Daudi cells CVCL_0008
Experiment 7 Reporting the Activity Date of This ADC [4]
Efficacy Data Half Maximum Growth Inhibitory Concentration (GI50) > 6667.00 pM Negative CD25 expression (CD25-; <1,000 CD25 molecules/cell)
Method Description
The inhibitory activity of ADCT-301 against cancer cell growth was evaluated in various human cancer cell lines in vitro. CD25-positive and -negative cell lines were incubated with increasing concentrations of ADCT-301 or free warhead (SG3199) for 96 hours before processing by the MTS assay.
In Vitro Model T lymphocytic leukemia HuT 78 cells CVCL_0337
Experiment 8 Reporting the Activity Date of This ADC [4]
Efficacy Data Half Maximum Growth Inhibitory Concentration (GI50) > 6667.00 pM Negative CD25 expression (CD25-; <1,000 CD25 molecules/cell)
Method Description
The inhibitory activity of ADCT-301 against cancer cell growth was evaluated in various human cancer cell lines in vitro. CD25-positive and -negative cell lines were incubated with increasing concentrations of ADCT-301 or free warhead (SG3199) for 96 hours before processing by the MTS assay.
In Vitro Model Adult acute myeloid leukemia KG-1 cells CVCL_0374
Experiment 9 Reporting the Activity Date of This ADC [4]
Efficacy Data Half Maximum Growth Inhibitory Concentration (GI50) 7.49 pM, 1.11 ng/mL Moderate CD25 expression (CD25++; 96,000 CD25 molecules/cell)
Method Description
The inhibitory activity of ADCT-301 against cancer cell growth was evaluated in various human cancer cell lines in vitro. CD25-positive and -negative cell lines were incubated with increasing concentrations of ADCT-301 or free warhead (SG3199) for 96 hours before processing by the MTS assay.
In Vitro Model Hodgkin lymphoma L-540 cells CVCL_1362
References
Ref 1 Camidanlumab tesirine in patients with relapsed or refractory lymphoma: a phase 1, open-label, multicentre, dose-escalation, dose-expansion study. Lancet Haematol. 2021 Jun;8(6):e433-e445.
Ref 2 Camidanlumab tesirine, an antibody-drug conjugate, in relapsed/refractory CD25-positive acute myeloid leukemia or acute lymphoblastic leukemia: A phase I study. Leuk Res. 2020 Aug;95:106385.
Ref 3 Exposure-response analysis of Camidanlumab tesirine in patients with relapsed or refractory classical Hodgkin lymphoma and non-Hodgkin lymphoma. Cancer Chemother Pharmacol. 2023 Jan;91(1):1-12.
Ref 4 ADCT-301, a Pyrrolobenzodiazepine (PBD) Dimer-Containing Antibody-Drug Conjugate (ADC) Targeting CD25-Expressing Hematological Malignancies. Mol Cancer Ther. 2016 Nov;15(11):2709-2721.

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