Ignite Creation Date:
2025-12-24 @ 11:48 AM
Ignite Modification Date:
2026-02-05 @ 1:47 PM
Study NCT ID:
NCT02545361
Status:
WITHDRAWN
Last Update Posted:
2018-08-16
First Post:
2015-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, and Anti-cancer Activity of KAHR-102 (The Study Drug) for the Treatment of Lymphoma Patients
Sponsor:
Kahr Medical
Organization:
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Program de-prioritized
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: