Clinical trial · Interventional
Safety, Tolerability, and Anti-cancer Activity of KAHR-102 (The Study Drug) for the Treatment of Lymphoma Patients
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
NCT02545361CI-TRIAL-00034385withdrawnPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Program de-prioritized
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KAHR-102 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- KAHR002
- description
- 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
- interventionNames
- Drug: KAHR-102
Primary outcomes (1)
- measure
- Evaluate incidence of adverse events
- timeFrame
- Up to 9 months
- description
- Safety, as determined by frequency, nature, and severity of adverse events; and the profile of dose limiting toxicities.
Secondary outcomes (4)
- measure
- Blood samplings for KAHR-102 levels
- timeFrame
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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%). * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.