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Classical Hodgkin LymphomaPhase 2NCT03580564

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

A Phase 2 study testing KL-A167 in people with Classical Hodgkin Lymphoma, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Classical Hodgkin Lymphoma
What is being tested?
KL-A167
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
109 participants
Where
1 siteChina
Study dates
1 Aug 2018to 13 Jan 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 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.
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  • 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.

Who cannot join

  • 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
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  • 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.
  • Known HIV infection.
  • Has history of interstitial lung disease or non-infectious pneumonitis. Subjects with prior drug-induced or radiation-induced pneumonitis who are asymptomatic are eligible.
  • Known active pulmonary tuberculosis
  • Has history of AE related with immune system during the Immunotherapy
  • Received a live vaccine within 4 weeks of the first dose of study medication or plan to receive live vaccine during study period.
  • Known neurological or psychiatric diseases
  • Ongoing alcohol or drug abuse
  • Pregnancy (absence to be confirmed by serum β-human chorionic gonadotropin test) or breastfeeding
  • Participation in another clinical trial within the past 4 weeks
  • Other significant disease that in the investigator's opinion should exclude the subject from the trial

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

Other trials in China

About this study

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

Being tested
KL-A167

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KL-A167Drug

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

Study groups in NCT03580564
Study groupRoleWhat they receive
ExperimentalExperimentalKL-A167 900 mg intravenously (IV) every-2-weeks (Q2W)
Receives: Drug: KL-A167

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Up to 2years

Secondary outcomes (4)

  1. Progression-free Survival (PFS)

    From the first dose of KL-A167 to the date of PD or death, whichever occurs first

    Measured: Up to 2years

  2. Duration of Response (DOR)

    From the date that response criteria are first met to the date that PD is objectively documented or death, whichever occurs first

    Measured: Up to 2years

  3. Overall Survival (OS)

    From the first dose of KL-A167 to the date of death

    Measured: Up to 2years

  4. Time to Response

    From the date of the first dose of KL-A167 to the time the response criteria are first met

    Measured: Up to 2years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2018
  2. Study start1 Aug 2018
  3. Primary completion22 Aug 2020
  4. Study completion13 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
109 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03580564
Sponsor's protocol ID
KL167-Ⅱ-03-CTP
Status last verified
Apr 2026
First submitted
26 Jun 2018
Last updated
5 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing KL-A167 in people with Classical Hodgkin Lymphoma, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (time frame: Up to 2years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03580564.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.

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