Relapsed Acute Lymphoblastic LeukemiaPhase 1NCT01743807
Phase I Study of GNKG168 in Acute Lymphoblastic Leukemia and Acute Myelogenous Leukemia
A Phase 1 study testing GNKG168 in people with Relapsed Acute Lymphoblastic Leukemia and Relapsed Acute Myelogenous Leukemia, run by Therapeutic Advances in Childhood Leukemia Consortium at 3 sites in United States.
Trial summary
This is a phase I trial of an investigational drug called GNKG168 in patients with relapsed and refractory acute lymphoblastic leukemia (ALL) and acute myelogenous leukemia (AML) who are in morphologic remission but are positive for Minimum Residual Disease (MRD). Read more about this study
- Who is it for?
- Ages 1 year to 21 years
- Conditions the study is for
- Relapsed Acute Lymphoblastic Leukemia, Relapsed Acute Myelogenous Leukemia
- What is being tested?
- GNKG168
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Mar 2014to 28 Jul 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 year to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age Patients must be ≥1 and ≤ 21 years of age when originally diagnosed with ALL or AML.
- Diagnosis
- Patients must have previously histologically confirmed ALL or AML at original diagnosis or previous relapse. Patients with treatment-related AML are eligible.
- Patients must be in complete remission (CR) with less than 5% blasts in the bone marrow.
- Post-HSCT patients should be in first or greater CR
- Patients who have never received HSCT should be in second or greater CR
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- Patient must have detectable MRD (≥0.01%) by flow cytometry.
- Performance Level Karnofsky ≥ 50% for patients >16 years of age and Lansky ≥ 50% for patients ≤16 years of age.
- Prior Therapy
- Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy.
- At least 14 days must have elapsed since any treatment with systemic chemotherapy including high-dose steroid (prednisone>0.5 mg/kg or equivalent), radiotherapy, biological therapy or any other investigational therapy. (Note: low-dose steroid; prednisone ≤0.5 mg/kg/day or equivalent is allowed.)
- At least 28 days must have elapsed since any cellular therapies such as chimeric antigen receptor-modified T cells.
- Patients who have never had HSCT must not be a suitable candidate for HSCT. For this protocol, a suitable candidate is defined as one who has an identified donor with plans to undergo transplant within the next 28 days.
- Previous HSCT:
- Patients having received HSCT are eligible and 60 days must have elapsed since stem cell infusion.
- Patients having received donor lymphocyte infusions (DLI) are eligible.
- At least 28 days must have elapsed from the last DLI.
- Must have ≥90% donor chimerism. The test for donor chimerism must have been done within the last 60 days. If patient has subsequently relapsed after HSCT but prior to enrollment on this study, the donor chimerism test is not needed.
- Patients must have been off all immune suppression drugs for 7 days before study entry. (at least 2 weeks for high-dose steroid, i.e. prednisone>0.5 mg/kg or equivalent; see 4b above) (Note; low-dose steroid; prednisone ≤0.5 mg/kg/day or equivalent is allowed.)
- Renal and Hepatic Function
- Patients must have a serum creatinine that is less than or equal to 1.5 x the institutional upper limit of normal according to age. (Grade 1 per the CTCAE 4.0)
- Patient's ALT and AST must be less than or equal to 3 x institutional upper limit of normal. (Grade 1 per the CTCAE 4.0)
- Patient's total bilirubin must be less than or equal to 1.5 x institutional upper limit of normal. (Grade 1 per the CTCAE 4.0)
- Cardiac Function Patient must have a shortening fraction > 27% by ECHO or an ejection fraction > 45% by MUGA.
- Reproductive Function
- Female patients of childbearing potential must have a negative urine or serum pregnancy test confirmed prior to enrollment.
- Female patients with infants must agree not to breastfeed their infants while on this study.
- Male and female patients of child-bearing potential must agree to use an effective method of contraception approved by the investigator during the study.
- Hematological Function Patients must have an absolute neutrophil count > 750/dL, platelets > 75,000/dL AND absolute lymphocyte count > 200/uL which is not decreasing. Patients with previous HSCT may have a platelet count > 50,000/dL.
Who cannot join
- Patients will be excluded if they meet any of the following criteria.
- Graft versus host disease (GVHD) that meets the following criteria:
- Active grade 2 or higher acute GVHD at the time of study entry.
- Active chronic GVHD (moderate or severe).
- Plan for donor lymphocyte infusions during the study period.
- Need for immunosuppressive medications including high-dose corticosteroids (prednisone >0.5 mg/kg or equivalent) (Note: low-dose steroid; prednisone ≤0.5 mg/kg/day or equivalent is allowed.)
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- Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
- Patient will be excluded if they are currently receiving other investigational drugs.
- Patients will be excluded if there is a plan to administer non-protocol chemotherapy, radiation therapy, or immunotherapy during the study period.
- Patients will be excluded if they have significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance with the prescribed protocol therapy, interfere with consent, study participation, follow up, or interpretation of study results.
- Patients with CNS 3 disease are excluded. No CNS therapy will be allowed during the first 2 courses of therapy.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins University
Baltimore, Maryland, 21231
Childrens Hospital Los Angeles
Los Angeles, California, 90027
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase I Study of GNKG168 in Pediatric Patients With Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia (IND#113600)
This is a phase I trial of an investigational drug called GNKG168 in patients with relapsed and refractory acute lymphoblastic leukemia (ALL) and acute myelogenous leukemia (AML) who are in morphologic remission but are positive for Minimum Residual Disease (MRD).
Read the detailed description
GNKG168 is a Toll-like receptor (TLR) agonist. TLR agonists are a novel approach to stimulate an effective anti-tumor immune response as they are able to stimulate both innate and adaptive immune responses. There will be two strata i.e patients who have received hematopoietic stem cell transplant (HSCT) and patients who have never undergone HSCT. GNKG168 will be administered as a 60 min iv infusion. One 14-day cycle consists of 5-day treatment followed by 9 day-rest. Patients will receive 2 cycles before evaluation. The primary objective is to determine the maximum tolerated dose of GNKG168 in relapsed ALL and AML patients. The completion of this study and the correlative studies will provide a solid foundation for subsequent phase 2 study and the development of clinical applications of CpG-ODN-based immune therapy as a treatment of childhood leukemia. If safety and efficacy of GNKG168 is proven, it will be intriguing to explore its role to maintain CR in a randomized manner.
- Being tested
- GNKG168
- Keywords
- Relapsed, Minimal Residual Disease, MRD, Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, ALL, AML, GNKG168, Pediatric, Childhood
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Recurrence, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GNKG168Drug
Also called CpG685
GNKG168 will be given intravenously over 1 hour on days 1 through 5 followed by 9 days of rest. Dose will be assigned at study entry.
Dose Level 0: 0.15 mg/kg Dose Level 1: 0.25 mg/kg Dose Level 2: 0.75 mg/kg Dose Level 3: 1.5 mg/kg
The starting dose level for the trial will be 0.25 mg/kg. If that dose level proves to be intolerable, the dose will be reduced to 0.15 mg/kg (dose level 0). If the 0.15 mg/kg dose level is intolerable due to DLTs, TACL, the Principal Investigator, and Medical Monitor will then decide the best course of action for subsequent administration of GNKG168.
| Study group | Role | What they receive |
|---|---|---|
| Post-HSCT | Experimental | Patients who have a history of hematopoetic stem cell transplantation (HSCT). GNKG168 will be administered as a 60 minute intravenous infusion daily for 5 consecutive days. It may be repeated every 14 days. Patients should receive minimum 2 courses and up to 6 courses may be administered. Dose will be assigned at study entry. Receives: Drug: GNKG168 |
| No HSCT | Experimental | Patients who have never undergone HSCT. GNKG168 will be administered as a 60 minute intravenous infusion daily for 5 consecutive days. It may be repeated every 14 days. Patients should receive minimum 2 courses and up to 6 courses may be administered. Dose will be assigned at study entry. Receives: Drug: GNKG168 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Dose Limiting Toxicity (DLT) in the First Two Courses of Therapy
DLT is defined as:
- Any non-hematologic toxicity that is ≥ CTCAE grade 3 and at least possibly related to GNKG168 (the relationship to GNKG168 cannot be ruled out), with the EXCEPTION of the following toxicities when observed at Grade 3:
- Fatigue
- Fever
- Anorexia
- Rash that turns to grade ≤ 2 within 7 days
- Elevation in hepatic transaminases (ALT/SGOT and AST/SGPT), GGT or alkaline phosphatase that returns to ≤ grade 2 within 14 days. It will not be considered a DLT if the patient exits the study and begins alternative therapy before the end of the 14 day evaluation period.
- Grade 3 or 4 hematologic toxicity that is at least possibly related to GNKG168 that does not reverse to baseline within 7 days.
- For patients who have undergone HSCT, DLT will include the onset of Grade 3 or 4 acute GVHD, the onset of moderate to severe chronic GVHD, the onset of bronchiolitis obliterans and graft failure.
Measured: Beginning with the first dose of GNKG168 until the end of course 2; courses are 14 days so there will be approximately 28 days of monitoring for DLT
Secondary outcomes (5)
The Number of Participants With a Decrease in Minimal Residual Disease (MRD) Present in Patients Treated With GNKG168
Doctors have developed a test to detect very small amounts of leukemia that still exist even though it looks like remission under a microscope. This test is called Minimal Residual Disease (MRD). MRD is very specific and can detect 1 cancer cell out of 10,000 regular cells. The results of the MRD test on bone marrow can show when a patient has a very small amount of cancer cells left in the bone marrow. We will use this test to evaluate the effect of GNKG168 in killing the small amount of cells left in your bone marrow.
Measured: Pre-study and End of Course 1 (Day 14)
Occurrence of Graft Versus Host Disease (GVHD) in Patients Who Had Previous HSCT and Received GNKG168
We will evaluate the impact of GNKG168 on induction of clinical GVHD using the consensus scoring system developed by NIH (Filipovich et. al., National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. Diagnosis and Staging Working Group Report, Biology of Blood and Marrow Transplantation, Volume 11, Issue 12, Dec. 2005, pp. 945-956)
Measured: Weekly during Courses 1 and 2 (i.e, 4 times in 28 days), Day 1 of Courses 3-6 (approximately Days 29, 43 and 57), and when patient is removed from protocol therapy.
Occurrence of Graft Failure in Patients Who Previously Had a HSCT and Received GNKG168
Peripheral blood samples will be evaluated for the presence of cGVHD biomarkers. Change in level of MRD, and MRD response following GNKG168
Measured: Day 14
Change in the Percent of ALL or AML Blasts Exhibiting Markers of Immunogenicity and Apoptosis
Change in the percent of ALL or AML blasts exhibiting markers of immunogenicity and apoptosis will be analyzed from bone marrow specimens.
Measured: End of Course 1 (Day 14), end of Course 2 (approx. Day 28), end of courses 4 and 6 (approx. Days 56 and 70), and date removed from therapy if previous marrow sample > 2 weeks ago
Duration of of Remission in Patients Who Receive GNKG168
- MRD negative Complete Remission : Negative MRD (<0.01%), no evidence of circulating leukemic blasts or extramedullary disease, and recovery of peripheral counts (ANC ≥ 500/µL and PLT count ≥ 50,000 µL).
- MRD negative Complete Remission without platelet recovery: Insufficient recovery of platelets (< 50,000/ µL) but otherwise meets the criteria of MRD-CR.
- Stable Disease: Patient does not satisfy the criterion for PD, or has recovery of ANC ≥ 500/µL and fails to qualify for MRD-CR or MRD-CRp.
- Progressive Disease: At least 5% of circulating leukemic cells or ≥5% in a marrow with count recovery, development of new sites of extramedullary disease, or other laboratory or clinical evidence of PD, with or without recovery of ANC or platelets.
- Not evaluable: Patient does not satisfy the criterion for PD, and did not have a marrow evaluation, had inadequate marrow cell count, or had insufficient recovery of ANC for MRD-CR, MRD-CRp or SD classification.
Measured: Until patient is no longer being followed (off study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study start26 Mar 2014
- Primary completion28 Jul 2014
- Study completion28 Jul 2014
Why it stopped: SBI Biotech (supplier) decided to no longer support the study or GNKG168.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Relapsed Acute Lymphoblastic LeukemiaStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Therapeutic Advances in Childhood Leukemia Consortium
- Sponsor type
- University, hospital or other
- Collaborators
- SBI Biotech Co., Ltd.
- Responsible party
- Principal investigator, Nobuko Hijiya, MD, Therapeutic Advances in Childhood Leukemia Consortium
- Investigators
- Nobuko Hijiya, MD, Study chair, Ann & Robert H Lurie Children's Hospital of ChicagoKirk Schultz, MD, Study chair, British Columbia Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743807
- Sponsor's protocol ID
- T2009-008
- Status last verified
- Dec 2024
- First submitted
- 28 Nov 2012
- Last updated
- 27 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of GNKG168 in Pediatric Patients With Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia (IND#113600)
- ClinicalTrials.gov ID
- NCT01743807
- Acronym / sponsor ID
- T2009-008
- Keywords
- Relapsed, Minimal Residual Disease, MRD, Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, ALL, AML, GNKG168
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: SBI Biotech (supplier) decided to no longer support the study or GNKG168.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Therapeutic Advances in Childhood Leukemia ConsortiumUniversity, hospital or other
- Collaborators
- SBI Biotech Co., Ltd.
- Study start
- 26 Mar 2014 (actual)
- Primary completion
- 28 Jul 2014 (actual)
- Study completion
- 28 Jul 2014 (actual)
- First posted
- 6 Dec 2012 (estimated)
- Results
- Posted 27 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase I trial of an investigational drug called GNKG168 in patients with relapsed and refractory acute lymphoblastic leukemia (ALL) and acute myelogenous leukemia (AML) who are in morphologic remission but are positive for Minimum Residual Disease (MRD).
Detailed description
GNKG168 is a Toll-like receptor (TLR) agonist. TLR agonists are a novel approach to stimulate an effective anti-tumor immune response as they are able to stimulate both innate and adaptive immune responses. There will be two strata i.e patients who have received hematopoietic stem cell transplant (HSCT) and patients who have never undergone HSCT. GNKG168 will be administered as a 60 min iv infusion. One 14-day cycle consists of 5-day treatment followed by 9 day-rest. Patients will receive 2 cycles before evaluation. The primary objective is to determine the maximum tolerated dose of GNKG168 in relapsed ALL and AML patients. The completion of this study and the correlative studies will provide a solid foundation for subsequent phase 2 study and the development of clinical applications of CpG-ODN-based immune therapy as a treatment of childhood leukemia. If safety and efficacy of GNKG168 is proven, it will be intriguing to explore its role to maintain CR in a randomized manner.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-HSCT | Experimental | Drug: GNKG168Patients who have a history of hematopoetic stem cell transplantation (HSCT). GNKG168 will be administered as a 60 minute intravenous infusion daily for 5 consecutive days. It may be repeated every 14 days. Patients should receive minimum 2 courses and up to 6 courses may be administered. Dose will be assigned at study entry. |
| No HSCT | Experimental | Drug: GNKG168Patients who have never undergone HSCT. GNKG168 will be administered as a 60 minute intravenous infusion daily for 5 consecutive days. It may be repeated every 14 days. Patients should receive minimum 2 courses and up to 6 courses may be administered. Dose will be assigned at study entry. |
Who may qualify
- Ages
- 1 year to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (29 listed)
- Age Patients must be ≥1 and ≤ 21 years of age when originally diagnosed with ALL or AML.
- Diagnosis
- Performance Level Karnofsky ≥ 50% for patients >16 years of age and Lansky ≥ 50% for patients ≤16 years of age.
- Prior Therapy
- Renal and Hepatic Function
Key exclusion criteria (11 listed)
- Patients will be excluded if they meet any of the following criteria.
- Graft versus host disease (GVHD) that meets the following criteria:
- Plan for donor lymphocyte infusions during the study period.
- Need for immunosuppressive medications including high-dose corticosteroids (prednisone >0.5 mg/kg or equivalent) (Note: low-dose steroid; prednisone ≤0.5 mg/kg/day or equivalent is allowed.)
- Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
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 |
|---|---|---|
| GNKG168Also: CpG685GNKG168 will be given intravenously over 1 hour on days 1 through 5 followed by 9 days of rest. Dose will be assigned at study entry. Dose Level 0: 0.15 mg/kg Dose Level 1: 0.25 mg/kg Dose Level 2: 0.75 mg/kg Dose Level 3: 1.5 mg/kg The starting dose level for the trial will be 0.25 mg/kg. If that dose level proves to be intolerable, the dose will be reduced to 0.15 mg/kg (dose level 0). If the 0.15 mg/kg dose level is intolerable due to DLTs, TACL, the Principal Investigator, and Medical Monitor will then decide the best course of action for subsequent administration of GNKG168. | Drug | No HSCT, Post-HSCT |
Primary outcome
Number of Patients With Dose Limiting Toxicity (DLT) in the First Two Courses of Therapy
Time frame: Beginning with the first dose of GNKG168 until the end of course 2; courses are 14 days so there will be approximately 28 days of monitoring for DLT
DLT is defined as: A) Any non-hematologic toxicity that is ≥ CTCAE grade 3 and at least possibly related to GNKG168 (the relationship to GNKG168 cannot be ruled out), with the EXCEPTION of the following toxicities when observed at Grade 3: * Fatigue * Fever * Anorexia * Rash that turns to grade ≤ 2 within 7 days * Elevation in hepatic transaminases (ALT/SGOT and AST/SGPT), GGT or alkaline phosphatase that returns to ≤ grade 2 within 14 days. It will not be considered a DLT if the patient exits the study and begins alternative therapy before the end of the 14 day evaluation period. B) Grade 3 or 4 hematologic toxicity that is at least possibly related to GNKG168 that does not reverse to baseline within 7 days. C) For patients who have undergone HSCT, DLT will include the onset of Grade 3 or 4 acute GVHD, the onset of moderate to severe chronic GVHD, the onset of bronchiolitis obliterans and graft failure.
5 secondary outcomes
The Number of Participants With a Decrease in Minimal Residual Disease (MRD) Present in Patients Treated With GNKG168
Time frame: Pre-study and End of Course 1 (Day 14)
Occurrence of Graft Versus Host Disease (GVHD) in Patients Who Had Previous HSCT and Received GNKG168
Time frame: Weekly during Courses 1 and 2 (i.e, 4 times in 28 days), Day 1 of Courses 3-6 (approximately Days 29, 43 and 57), and when patient is removed from protocol therapy.
Occurrence of Graft Failure in Patients Who Previously Had a HSCT and Received GNKG168
Time frame: Day 14
Change in the Percent of ALL or AML Blasts Exhibiting Markers of Immunogenicity and Apoptosis
Time frame: End of Course 1 (Day 14), end of Course 2 (approx. Day 28), end of courses 4 and 6 (approx. Days 56 and 70), and date removed from therapy if previous marrow sample > 2 weeks ago
Duration of of Remission in Patients Who Receive GNKG168
Time frame: Until patient is no longer being followed (off study)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Therapeutic Advances in Childhood Leukemia \& Lymphoma Consortium web siteLink provided by the sponsor.
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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.
Nobuko Hijiya, MD study chair
Ann & Robert H Lurie Children's Hospital of Chicago
Kirk Schultz, MD study chair
British Columbia Children's Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GNKG168 in people with Relapsed Acute Lymphoblastic Leukemia and Relapsed Acute Myelogenous Leukemia, run by Therapeutic Advances in Childhood Leukemia Consortium at 3 sites in United States.
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 29 inclusion and 11 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: stopped early, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients With Dose Limiting Toxicity (DLT) in the First Two Courses of Therapy (time frame: Beginning with the first dose of GNKG168 until the end of course 2; courses are 14 days so there will be approximately 28 days of monitoring for DLT). 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 27 Jan 2025.