An Open, Multicenter Phase II Study to Evaluate the Safety and Efficacy of KL-A167 Injection in Relapsed or Refractory Classical Hodgkin's Lymphoma

NCT03580564 | Completed Phase 2

• 1 other identifier: KL167-Ⅱ-03-CTP
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

The study is to evaluate the efficacy of KL-A167 a in subjects with relapsed or refractory classical Hodgkin lymphoma (cHL), as measured by Overall Response Rate (ORR) per the Lugano Classification

Conditions

Classical Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Overall Response Rate (ORR) defined as the proportion of subjects who achieves a best response of CR or PR, assessed by IRC per the Lugano Classification

  Up to 2years

Secondary Outcomes (4)

• Progression-free Survival (PFS)

  Up to 2years

• Duration of Response (DOR)

  Up to 2years

• Overall Survival (OS)

  Up to 2years

• Time to Response

  Up to 2years

Study Arms (1)

Experimental

EXPERIMENTAL

KL-A167 900 mg intravenously (IV) every-2-weeks (Q2W)

Drug: KL-A167

Interventions

KL-A167 DRUG

KL-A167 900 mg intravenously (IV) every-2-weeks (Q2W)

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older
• Histopathological confirmed classical Hodgkin's lymphoma
• Relapsed/refractory cHL include：subject with no response to or with progression after ASCT ；subject which failed failed second line and above chemtherapy；subject which didn't achieve PR after 2 cycles or didn't achieve CR after 4 cycles
• At least one measurable disease (long axis\>15 mm and short axis\>5 mm,or both axis\>10 mm）
• ECOG performance status of 0 or 12
• Subject must have adequate organ functions and meet requirements on laboratory values.：Count of Blood Cells: absolute neutrophil count (ANC) ≥ 1.0 × 109 / L; platelet count (PLT) ≥ 50 × 109 / L; hemoglobin content (HGB) ≥ 7.0 g / Dl; Liver function: serum total bilirubin (TBIL) ≤ 1.5 × normal upper limit (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN，with the exception of patients with hepatic metastases (ALT and AST ≤ 5 × ULN) and patients with hepatic metastases or Gilbert's syndrome (total bilirubin ≤ 3 × ULN)Renal function: serum creatinine (Cr) ≤ 1.5 × ULN or Creatinine clearance rate（CCR）≥50 mL/min；International normalized ratio (INR) ≤ 1.5 x ULN ；Thyroid function: thyroid stimulating hormone (TSH) in normal range.
• Prior chemotherapy, radiotherapy, immunotherapy or investigational therapy (including Chinese herbal medicine and Chinese patent medicine) used to control cancer including locoregional treatment must have been completed ≥ 4 weeks before the first dose of KL-A167(Mitomycin or nitroso must have been completed ≥ 6 weeks), and all treatment-related adverse events (except alopecia) are stable and have either returned to baseline or Grade 0/1
• Subjects of reproductive potential must be willing to use adequate contraception during the course of the study and through 6 months after the last dose of study medication
• Subject has voluntarily agreed to participate by giving written informed consent.

You may not qualify if:

• Nodular lymphocyte-predominant Hodgkin lymphoma or gray zone lymphoma.
• Known central nervous system lymphoma.
• Prior malignancy except for curatively treated carcinoma in situ of the cervix or breast ，Superficial bladder cancer，and Squamous cell carcinoma in situ
• History of severe hypersensitivity reaction to monoclonal antibodies
• Prior exposure to any anti-PD-1, anti-PD-L1 or anti-CTLA-4 antibody.
• need the other anticancer therapy during the study
• Received any anticancer vaccine or other medications for immunomodulatory receptor preparations
• Received HSCT
• Received ASCT in the past 3 months
• Serious acute or chronic infection requiring systemic therapy.
• Subject with active autoimmune disease or history of autoimmune disease with high risk of recurrence.
• Conditions requiring systemic treatment with either corticosteroids (\> 10 mg daily Prednisone equivalent) or other immunosuppressive medications within 14 days of first dose of KL-A167
• serious medical diseases, ex Suffering from heart failure (New York Heart Association standard III or IV), ischemic heart disease (such as myocardial infarction or angina), congestive heart failure and other cardiovascular diseases, uncontrolled diabetes(fasting blood glucose≥10 mmol/L), uncontrolled high blood pressure(Systolic\> 150 mmHg and / or diastolic\> 100 mmHg), LVEF\<50%
• QTcF\>450 msec
• Known active HBV or HCV infection.

Sponsors & Collaborators

• Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Interventions

18-O-demethylcervinomycin A2

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: July 9, 2018
• Study Start: August 1, 2018
• Primary Completion: August 22, 2020
• Study Completion: January 13, 2022
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

CN (1)