New drug shows promise for Tough-to-Treat hodgkin lymphoma
NCT ID NCT03580564
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tested a drug called KL-A167 in 109 adults with classical Hodgkin lymphoma that had returned or not responded to prior treatments. Participants received the drug intravenously every two weeks. The main goal was to see how many patients' tumors shrank or disappeared. The study also tracked how long any response lasted and overall survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- KL-A167 (a drug given intravenously every two weeks)
- What this could lead to
- If successful, this could offer a new treatment option for people with Hodgkin lymphoma that has not responded to other therapies.
- What could go wrong
- This is a mid-stage trial with only 109 participants, so results may not apply to everyone. The drug may cause side effects or fail to shrink tumors in some patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
109 people
The number who actually took part.
- Started
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Aug 2018
- Finished
-
Jan 2022
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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. * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a new pill boost Immunotherapy's power against advanced tumors?
- Can a new nucleotide analogue boost cancer treatment?
- Can a drug duo outsmart resistant lymphomas?
- Immunotherapy may let some hodgkin lymphoma patients avoid intensive chemo and radiation
- Two-Drug combo aims to tackle Hard-to-Treat hodgkin lymphoma