LymphomaPhase 1/2NCT02545361
Safety, Tolerability, and Anti-cancer Activity of KAHR-102 (The Study Drug) for the Treatment of Lymphoma Patients
A Phase 1/2 study testing KAHR-102 in people with Lymphoma, run by Kahr Medical.
Trial summary
The purpose of this study is to evaluate the safety and to determine the Dose Limiting Toxicity (DLT) and the Maximal Tolerated Dose (MTD) of KAHR-102. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- KAHR-102
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2018to Apr 2020
- Phase
- Phase 1/2
- 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
- Subjects diagnosed with recurrent malignant lymphoma, which express B7 and FasR and have either failed to respond to standard therapy, relapsed and for whom no standard therapy is available.
- Measurable disease as measured by "Lugano" Classification.
- A measurable node must have a longest diameter (LDi) greater than 1.5 cm. Measurable extranodal disease (eg, hepatic nodules) may be included in the six representative, measured lesions. A measurable extranodal lesion should have an LDi greater than 1.0 cm
- Biopsy of tumor stains positive to cluster of differentiation 95 (CD95) and to Cluster of Differentiation 80 (CD80) or Cluster of Differentiation 86 (CD86) or both within the last 6 months.
- If greater than 6 months , a fine-needle aspiration (FNA) should be performed
- Men and Women age > 18.
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- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 3.
- Estimated life expectancy of at least 2 months.
- Adequate liver function (serum bilirubin ≤2.0 mg/100 ml; alanine aminotransferase, aspartate aminotransferase ≤2× ULN).
- Adequate renal function (serum creatinine ≤1.5 mg/100 ml or creatinine clearance ≥30 ml/min/1.73m2 as measured by Cockcroft -Gault / CKD (Chronic Kidney Disease)/EPI (Epidemiology Collaboration) formulas.
- Platelet count ≥ 50,000 and an absolute neutrophil count (ANC) ≥ 1500 /mm3.
- Women of child bearing potential practicing an acceptable method of birth control.
- Understanding of study procedures and willingness to comply for the entire length of the study and to give written informed consent.
Who cannot join
- Other standard anti-neoplastic therapies are available.
- Known Central Nervous System (CNS) lymphoma.
- Chronic lymphocytic leukemia and autoimmunity leukemia.
- Known hypersensitivity to the study drug or to any of its components.
- Chronic heat failure (CHF) New-York heart association (NYHA) = Class IV.
- Known Chronic Obstructive Pulmonary Disease (COPD) > Stage 3 (Forced Expiratory Volume -(FEV1)<50%, FEV1/Forced Vital Capacity (FVC)<70%).
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- Chronic kidney disease (CKD) >Stage 4 (subjects with known Filtration rate (FR)<30 milliliter (mL)/min/1.73m2).
- Cirrhosis (Child-Pugh Class C score).
- Known hypersensitivity to drug components.
- Prior chemotherapy within 3 weeks, nitrosureas within 6 weeks, therapeutic anticancer antibodies within 3 weeks, radio or toxin immunoconjugates within 10 weeks, radiation therapy within 3 weeks, or major surgery within 28 days of first dose of the study drug.
- American Society for Cytotechnology (ASCT) and prior allogeneic stem cell transplantation (SCT)< 12 weeks prior to first dose of the study drug.
- Myelosuppressive treatment within 2-3 weeks of entering this study. Prednisone allowed.
- Any other severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for entry into this study.
- Positive test for acquired immune deficiency syndrome (AIDS).
- Any positive test for hepatitis B or hepatitis C virus (HBV or HCV) indicating acute or chronic infection (HBsAg, HBcAb total and anti-HCV Abs).
- Presence of uncontrolled infection.
- Evidence of active bleeding or bleeding susceptibility or medically significant hemorrhage within prior 30 days.
- Coumadin therapy.
- Pregnant or lactating.
- Treatment with other investigational drugs within 14 days of start of this study.
- Prisoners or subjects who are involuntarily incarcerated.
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.
About this study
Official title: A Phase 1/2a, Multi-center, Dose Escalation, 2 Stages Study to Evaluate the Safety, Tolerability, and Anti-cancer Activity of Subcutaneously Administered KAHR-102 for the Treatment of Lymphoma Patients Who Express Both B7 and FasR
The purpose of this study is to evaluate the safety and to determine the Dose Limiting Toxicity (DLT) and the Maximal Tolerated Dose (MTD) of KAHR-102.
Read the detailed description
Subjects will have a screening visit for determination of eligibility. Up to 40 evaluable subjects will be included in the study; up to 30 in stage 1, and 10 in stage 2.
The study is divided into 2 stages:
- Dose escalation - Stage 1A and 1B
- Dose Confirmation Phase - Stage 2
Stage 1A:
Will start with 3 subjects receiving premedication (20mg Dexamethasone Intravenous (IV), 10mg Loratadine Per Os (P.O), and 1gr Paracetamol (P.O), 1 hour before treatment) with 2 micrograms/kilograms (µg/kg) KAHR-102 subcutaneous (SC) injection every 14 days for 3 injections. 3 injections will be defined as 1 cycle.
Eligible subjects will be hospitalized for 48 hours following each study drug administration. Blood will be collected before and 24 hours (h) following the study drug administration for biochemistry, hematology and cytokine levels.
Pharmacokinetic (PK) samples will be collected during hospitalization for the first and third KAHR-102 SC injections. Sampling for PK will be repeated on Day 4, 7, 32 and 35.
Sampling for Anti Drug Antibodies (ADAs) will be taken before all 3 KAHR-102 SC injections. CT scan and ADAs will be repeated at Day 49.
Stage 1B:
Based on safety results from Stage 1A and Clinical Safety Committee (CSC) decision, 12 further eligible subjects will be assigned to 1 of 4 cohorts to receive a SC injection of KAHR-102 with pre-medication (20mg Dexamethasone (IV), 10mg Loratadine (P.O), and 1gr Paracetamol (P.O), all 1 hour before the KAHR-102 SC injection, once every 7 days for 3 injections starting with 2µg/kg KAHR-102 SC injection. 3 injections will be defined as 1 Cycle.
Eligible subjects will be hospitalized for 48 hours following each KAHR-102 SC injection.
Blood samples will be collected before and 24h following the administration of KAHR-102 SC injection for biochemistry, hematology and cytokines level.
PK samples will be collected during hospitalization for first and third KAHR-102 SC injections. PK will also be assessed on Days 4, 7 (before administration of second KAHR-102 SC injection), 18 and 21.
Sampling for ADA testing will be taken before administration of first and third KAHR-102 SC injections. CT scan and ADA sampling will be performed on Day 35.
Stage 2:
Following completion of Stage 1, safety assessment by CSC and determination of MTD will be performed. 10 subjects will be treated at MTD. KAHR-102 SC injection will be given every 7 days for 3 injections. 3 injections will be defined as 1 Cycle.
Subjects will be hospitalized during treatment for 48 hours following each KAHR-102 SC injection.
Blood will be collected before and 24h following the administration of KAHR-102 SC injection for biochemistry, hematology, cytokines level.
PK sampling will be taken during hospitalization for first and third KAHR-102 SC injections and repeated on days 4, 7(before administration of second injection), 18, 21.
Samples for ADA testing will be collected prior to the first and third KAHR-102 SC injections. At Day 35 ADA sampling and CT scan will be repeated.
Cycles will be repeated at a frequency of 28 days after third KAHR-102 SC injection of 1st cycle and 14 days after 2nd cycle and following cycles Treatment will be discontinued based on investigator decision if CT scan shows evidence of disease progression or for any safety issues. The process will be overseen by the CSC.
- Conditions
- Lymphoma
- Being tested
- KAHR-102
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KAHR-102Drug
KAHR-102 is a dual signaling protein (DSP).KAHR-102 will be administrated subcutaneously. In Stage 1A, 3 KAHR-102 SC injections will continue to be given every 14 days with an interval of 28 days after 1st cycle and 14 days after 2nd cycle and following cycles.
In Stage 1B and Stage 2, subjects will be administered 3 KAHR-102 SC injections given every 7 days with an interval of 28 days after 1st cycle and 14 days after 2nd cycle and following cycles.
Planned doses for stage 1:
Cohort A: 2µg/kg Cohort B: 4 µg/kg Cohort C: 8 µg/kg Cohort D: 12 µg/kg Each cohort will only begin its first administration of KAHR-102 SC injection when the cohort preceding it will not meet criteria for a DLT (at least 7 days).
| Study group | Role | What they receive |
|---|---|---|
| KAHR002 | Experimental | premedication (20mg Dexamethasone (IV), 10mg Loratadine (P.O), and 1gr Paracetamol (P.O), 1 hour before treatment) with 2µg/kg KAHR-102 subcutaneous (SC) injection Receives: Drug: KAHR-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate incidence of adverse events
Safety, as determined by frequency, nature, and severity of adverse events; and the profile of dose limiting toxicities.
Measured: Up to 9 months
Secondary outcomes (4)
Blood samplings for KAHR-102 levels
KAHR-102 pharmacokinetic profile by plasma concentrations.
Measured: Stage 1A: Pre-dose, days 1, 2, 28, 29 (Injections 1 and 3). Stages 1B and 2: Pre-dose, days 1, 2 ,14 ,15 (Injections 1 and 3). Repeated on Day 4, 7, 32 and 35.
Blood sampling for Anti-Drug Antibodies (ADAs)
Sampling for Anti-Drug Antibodies
Measured: Stage 1A: Pre-dose day 1, 14, 28 in all cycles, day 49; Stages 1B and 2: Pre-dose day 1 and 28 in all cycles, day 35.
Tumors measurements
CT scan
Measured: Stage 1A: Pre-dose, day 49; Stages 1B and 2: Pre-dose, day 35 and every 10 weeks on average.
Optional "LUGANO" classification response
Evaluation, staging, and assessment of response in patients with Hodgkin lymphoma and non-Hodgkin lymphoma
Measured: Stage 1A: Pre-dose, day 49; Stages 1B and 2: Pre-dose, day 35 and every 10 weeks on average.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study startApr 2018 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Why it stopped: Program de-prioritized
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahr Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chava Sarfati, Pharm, Study chair, Kahr Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545361
- Sponsor's protocol ID
- KAHR002
- Status last verified
- Aug 2018
- First submitted
- 4 Aug 2015
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a, Multi-center, Dose Escalation, 2 Stages Study to Evaluate the Safety, Tolerability, and Anti-cancer Activity of Subcutaneously Administered KAHR-102 for the Treatment of Lymphoma Patients Who Express Both B7 and FasR
- ClinicalTrials.gov ID
- NCT02545361
- Acronym / sponsor ID
- KAHR002
- Conditions
- Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Program de-prioritized
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kahr MedicalIndustry (pharma, biotech, devices)
- Study start
- Apr 2018 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 10 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and to determine the Dose Limiting Toxicity (DLT) and the Maximal Tolerated Dose (MTD) of KAHR-102.
Detailed description
Subjects will have a screening visit for determination of eligibility. Up to 40 evaluable subjects will be included in the study; up to 30 in stage 1, and 10 in stage 2.
The study is divided into 2 stages:
- Dose escalation - Stage 1A and 1B
- Dose Confirmation Phase - Stage 2
Stage 1A:
Will start with 3 subjects receiving premedication (20mg Dexamethasone Intravenous (IV), 10mg Loratadine Per Os (P.O), and 1gr Paracetamol (P.O), 1 hour before treatment) with 2 micrograms/kilograms (µg/kg) KAHR-102 subcutaneous (SC) injection every 14 days for 3 injections. 3 injections will be defined as 1 cycle.
Eligible subjects will be hospitalized for 48 hours following each study drug administration. Blood will be collected before and 24 hours (h) following the study drug administration for biochemistry, hematology and cytokine levels.
Pharmacokinetic (PK) samples will be collected during hospitalization for the first and third KAHR-102 SC injections. Sampling for PK will be repeated on Day 4, 7, 32 and 35.
Sampling for Anti Drug Antibodies (ADAs) will be taken before all 3 KAHR-102 SC injections. CT scan and ADAs will be repeated at Day 49.
Stage 1B:
Based on safety results from Stage 1A and Clinical Safety Committee (CSC) decision, 12 further eligible subjects will be assigned to 1 of 4 cohorts to receive a SC injection of KAHR-102 with pre-medication (20mg Dexamethasone (IV), 10mg Loratadine (P.O), and 1gr Paracetamol (P.O), all 1 hour before the KAHR-102 SC injection, once every 7 days for 3 injections starting with 2µg/kg KAHR-102 SC injection. 3 injections will be defined as 1 Cycle.
Eligible subjects will be hospitalized for 48 hours following each KAHR-102 SC injection.
Blood samples will be collected before and 24h following the administration of KAHR-102 SC injection for biochemistry, hematology and cytokines level.
PK samples will be collected during hospitalization for first and third KAHR-102 SC injections. PK will also be assessed on Days 4, 7 (before administration of second KAHR-102 SC injection), 18 and 21.
Sampling for ADA testing will be taken before administration of first and third KAHR-102 SC injections. CT scan and ADA sampling will be performed on Day 35.
Stage 2:
Following completion of Stage 1, safety assessment by CSC and determination of MTD will be performed. 10 subjects will be treated at MTD. KAHR-102 SC injection will be given every 7 days for 3 injections. 3 injections will be defined as 1 Cycle.
Subjects will be hospitalized during treatment for 48 hours following each KAHR-102 SC injection.
Blood will be collected before and 24h following the administration of KAHR-102 SC injection for biochemistry, hematology, cytokines level.
PK sampling will be taken during hospitalization for first and third KAHR-102 SC injections and repeated on days 4, 7(before administration of second injection), 18, 21.
Samples for ADA testing will be collected prior to the first and third KAHR-102 SC injections. At Day 35 ADA sampling and CT scan will be repeated.
Cycles will be repeated at a frequency of 28 days after third KAHR-102 SC injection of 1st cycle and 14 days after 2nd cycle and following cycles Treatment will be discontinued based on investigator decision if CT scan shows evidence of disease progression or for any safety issues. The process will be overseen by the CSC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KAHR002 | Experimental | Drug: KAHR-102premedication (20mg Dexamethasone (IV), 10mg Loratadine (P.O), and 1gr Paracetamol (P.O), 1 hour before treatment) with 2µg/kg KAHR-102 subcutaneous (SC) injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects diagnosed with recurrent malignant lymphoma, which express B7 and FasR and have either failed to respond to standard therapy, relapsed and for whom no standard therapy is available.
- Measurable disease as measured by "Lugano" Classification.
- A measurable node must have a longest diameter (LDi) greater than 1.5 cm. Measurable extranodal disease (eg, hepatic nodules) may be included in the six representative, measured lesions. A measurable extranodal lesion should have an LDi greater than 1.0 cm
- Biopsy of tumor stains positive to cluster of differentiation 95 (CD95) and to Cluster of Differentiation 80 (CD80) or Cluster of Differentiation 86 (CD86) or both within the last 6 months.
- If greater than 6 months , a fine-needle aspiration (FNA) should be performed
Key exclusion criteria (22 listed)
- Other standard anti-neoplastic therapies are available.
- Known Central Nervous System (CNS) lymphoma.
- Chronic lymphocytic leukemia and autoimmunity leukemia.
- Known hypersensitivity to the study drug or to any of its components.
- Chronic heat failure (CHF) New-York heart association (NYHA) = Class IV.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KAHR-102KAHR-102 is a dual signaling protein (DSP).KAHR-102 will be administrated subcutaneously. In Stage 1A, 3 KAHR-102 SC injections will continue to be given every 14 days with an interval of 28 days after 1st cycle and 14 days after 2nd cycle and following cycles. In Stage 1B and Stage 2, subjects will be administered 3 KAHR-102 SC injections given every 7 days with an interval of 28 days after 1st cycle and 14 days after 2nd cycle and following cycles. Planned doses for stage 1: Cohort A: 2µg/kg Cohort B: 4 µg/kg Cohort C: 8 µg/kg Cohort D: 12 µg/kg Each cohort will only begin its first administration of KAHR-102 SC injection when the cohort preceding it will not meet criteria for a DLT (at least 7 days). | Drug | KAHR002 |
Primary outcome
Evaluate incidence of adverse events
Time frame: Up to 9 months
Safety, as determined by frequency, nature, and severity of adverse events; and the profile of dose limiting toxicities.
4 secondary outcomes
Blood samplings for KAHR-102 levels
Time frame: Stage 1A: Pre-dose, days 1, 2, 28, 29 (Injections 1 and 3). Stages 1B and 2: Pre-dose, days 1, 2 ,14 ,15 (Injections 1 and 3). Repeated on Day 4, 7, 32 and 35.
Blood sampling for Anti-Drug Antibodies (ADAs)
Time frame: Stage 1A: Pre-dose day 1, 14, 28 in all cycles, day 49; Stages 1B and 2: Pre-dose day 1 and 28 in all cycles, day 35.
Tumors measurements
Time frame: Stage 1A: Pre-dose, day 49; Stages 1B and 2: Pre-dose, day 35 and every 10 weeks on average.
Optional "LUGANO" classification response
Time frame: Stage 1A: Pre-dose, day 49; Stages 1B and 2: Pre-dose, day 35 and every 10 weeks on average.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chava Sarfati, Pharm study chair
Kahr Medical
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing KAHR-102 in people with Lymphoma, run by Kahr Medical.
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 13 inclusion and 22 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: withdrawn, as of the sponsor's last update on 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was withdrawn before enrolling participants, so there are no results.
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?
Evaluate incidence of adverse events (time frame: Up to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2018.