Squamous Cell Carcinoma of Head and NeckPhase 1/2NCT05099549
Safety, Tolerability, and Anti-Tumor Activity of AFM24 in Combination With SNK01 in Subjects With Advanced/Metastatic EGFR-Expressing Cancers
A Phase 1/2 study testing AFM24 and SNK01 in people with Squamous Cell Carcinoma of Head and Neck and Carcinoma, Non-Small-Cell Lung, run by NKGen Biotech, Inc. at 3 sites in United States.
Trial summary
This is an open-label, multi-center study to evaluate the safety, tolerability, and anti-tumor activity of SNK01 in combination with AFM24 in subjects with advanced or metastatic EGFR-expressing cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of Head and Neck, Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms
- What is being tested?
- AFM24 and SNK01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Nov 2021to 21 Sep 2023
- 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
- Capable of giving signed informed consent
- Males and females age ≥ 18 years
- Phase 1/Dose Escalation : any histologically confirmed advanced or metastatic EGFR-positive malignancy for which all standard of care treatment options have been received and are no longer effective or are considered inappropriate at the discretion of the investigator.
- Phase 2a/Expansion : histologically confirmed advanced or metastatic EGFR positive malignancy of mCRC (EXP-1 cohort), SCCHN (EXP-2 cohort) or NSCLC (EXP-3 cohort).
- Additional Criteria for Phase 2a/Expansion: subjects must have a disease history specific to their disease as listed below:
- EXP-1: mCRC. Metastatic colorectal cancer (mCRC) MSI low/DNA mismatch repair proficient. Subjects must have received ≥ 1 lines of previous combination therapy and must have been exposed to oxaliplatin, irinotecan, a fluoropyrimidine, a VEGF targeting agent and, if considered appropriate by the treating physician, an EGFR targeted antibody.
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- EXP-2: SCCHN. Subjects with advanced or metastatic SCCHN whose disease has progressed after having received ≥ 1 prior lines of therapy for advanced disease, which must have included platinum-based therapy, fluoropyrimidine, and an anti PD 1/PD-L1 antibody.
- EXP-3: NSCLC. Subjects with advanced or metastatic EGFR-expressing NSCLC (EGFR WT) whose disease has progressed after having received ≥ 1 prior lines of therapy for advanced disease. Subjects must have received at least a platinum-based doublet in combination with anti-PD1/PD-L1 antibody or must have received a platinum-based doublet followed by an anti-PD1/PD-L1 antibody.
- One or more measurable tumors lesions per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate bone marrow, hepatic and renal function.
Who cannot join
- Superior vena cava syndrome contra-indicating hydration
- Untreated or symptomatic central nervous system (CNS) metastases
- No resolution of specific toxicities related to any prior anti-cancer therapy to Grade ≤ 1 according to the NCI-CTCAE v.5.0 (except peripheral or motor neuropathy, lymphopenia and alopecia)
- Treatment with systemic anticancer therapy or an investigational device within 4 weeks (6 weeks if therapy was mitomycin C and/or nitrosoureas), or within 5 half-lives of the agent (if half-life is known and it is shorter) before the first dose of study treatment.
- Radiation therapy within 2 weeks before first dose of any study treatment or unresolved (NCI CTCAE v5.0 Grade > 1) toxicity from previous radiotherapy
- Clinically significant cardiovascular disease
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- Major surgery within 4 weeks prior to any study treatment administration
- Any pulmonary, thyroid, renal, hepatic severe/uncontrolled concurrent medical disease that in the opinion of the Investigator could cause unacceptable safety risks or compromise compliance with the protocol
- Active uncontrolled viral, fungal, or bacterial infection requiring systematic therapy within 14 days prior to first dose of study treatment.
- Known history of testing positive for human immunodeficiency virus (HIV), and/or positive test for Hepatitis B virus surface antigen (HBsAg) and/or positive Hep C antibody result with detectable hepatitis C virus (HCV) ribonucleic acid (RNA) indicating acute or chronic infection.
- Autoimmune disease requiring therapy; immunodeficiency, or any disease process requiring systemic immunosuppressive therapy
- A serious nonmalignant disease that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor
- Any other condition that, in the opinion of the Investigator, would prohibit the subject from participating in the study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Chicago
Chicago, Illinois, 60611
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Sarcoma Oncology Center
Santa Monica, California, 90403
About this study
Official title: A Phase 1/2a, Open-Label, Multi-Center Study Evaluating the Safety, Tolerability, and Anti-Tumor Activity of AFM24 in Combination With Ex Vivo Expanded Autologous Natural Killer Cells (SNK01) in Subjects With Advanced/Metastatic EGFR-Expressing Cancers
This is an open-label, multi-center study to evaluate the safety, tolerability, and anti-tumor activity of SNK01 in combination with AFM24 in subjects with advanced or metastatic EGFR-expressing cancers.
Read the detailed description
The study will be conducted in two phases. The Phase 1/dose escalation phase will gather preliminary safety and tolerability data for escalating doses of AFM24 in combination with SNK01 at a fixed dose in order to determine the MTD/RP2D for the combination dose regimen to be used in the Phase 2a/expansion.
The Phase 2a/expansion portion of the study will gather additional safety, tolerability, efficacy, and anti-tumor activity information for the combination of AFM24 with SNK01 in subjects with three types of advanced or metastatic EGFR-expressing cancers.
- Conditions
- Squamous Cell Carcinoma of Head and Neck, Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Advanced Solid Tumor, Refractory Tumor, Metastatic Tumor
- Being tested
- AFM24, SNK01
- Keywords
- EGFR Positive, EGFR, EGFR+, AFM24, SNK01, Solid tumor, Lung cancer, Refractory, Metastatic, NSCLC, SCCHN, NK cells, Natural killer cell, IgG1, antibody, CD16A, ADCC, ADCP
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Neoplasms, Neoplasm Metastasis, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFM24Drug
Tetravalent, bispecific EGFR- and CD16A-binding innate cell engager.
SNK01Biological
Patient-specific ex-vivo expanded autologous natural killer cells.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1, Dose Escalation | Experimental | It is estimated that approximately 3-6 subjects will be enrolled per cohort in three dose cohorts for a total of 12-18 participants.
SNK01 (fixed dose) will be administered weekly by IV infusion. Receives: Drug: AFM24; Biological: SNK01 |
| Phase 2a, Expansion Cohort 1 - Metastatic colorectal cancer (EXP-1: mCRC) | Experimental | SNK01 (fixed dose) will be administered weekly by IV infusion. Receives: Drug: AFM24; Biological: SNK01 |
| Phase 2a, Expansion Cohort 2 - Head and Neck Squamous Cell Carcinoma (EXP-2: SCCHN) | Experimental | SNK01 (fixed dose) will be administered weekly by IV infusion. Receives: Drug: AFM24; Biological: SNK01 |
| Phase 2a, Expansion Cohort 3 - Non-small cell lung cancer (EXP-3: NSCLC) | Experimental | SNK01 (fixed dose) will be administered weekly by IV infusion. Receives: Drug: AFM24; Biological: SNK01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1/Dose Escalation
Determine the maximum tolerated dose (MTD) of AFM24 in combination with SNK01. To be assessed by the incidence and severity of dose-limiting toxicity (DLT) within the DLT observation period.
Measured: 28 days starting on cycle 1 day 1
Phase 1/Dose Escalation
Determine the recommended phase 2 dose (RP2D) of AFM24 in combination with SNK01.
To be assessed by the incidence and severity of dose-limiting toxicity (DLT) within the DLT observation period.
Measured: 28 days starting on cycle 1 day 1
Phase 2a/Expansion
Determine objective response rate (ORR) of AFM24 in combination with SNK01. Determine ORR using Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1
Measured: Up to 24 months
Secondary outcomes (17)
Phase 1/Dose Escalation
Assess safety and tolerability of AFM24 in combination with SNK01. Determine frequency and severity of treatment-emergent AEs (TEAEs) per National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI CTCAE v 5.0).
Measured: Up to 24 months
Phase 1/Dose Escalation
Determine preliminary efficacy of AFM24 in combination with SNK01. Determine ORR using RECIST v1.1 evaluated by local assessment.
Measured: Up to 24 months
Phase 1/Dose Escalation
Maximum observed plasma concentration (Cmax) of AFM24
Measured: 28 days starting on cycle 1 day 1
Phase 1/Dose Escalation
Time to maximum plasma concentration (Tmax) of AFM24
Measured: 28 days starting on cycle 1 day 1
Phase 1/Dose Escalation
Minimum plasma concentration (Cmin) of AFM24
Measured: 28 days starting on cycle 1 day 1
Phase 1/Dose Escalation
Area under plasma concentration-time curve for dosing interval (AUCtau) of AFM24
Measured: 28 days starting on cycle 1 day 1
Phase 1/Dose Escalation
Immunogenicity of AFM24 when AFM24 is given in combination with SNK01 Frequency of subjects developing AFM24 anti drug antibodies (ADAs) through completion of the Phase 1/dose escalation portion
Measured: Up to 24 months
Phase 2a/Expansion
Safety and tolerability of AFM24 in combination with SNK01 Frequency of TEAEs graded according to NCI CTCAE v 5.0
Measured: Up to 24 months
Phase 2a/Expansion
To assess progression-free survival (PFS) according to RECIST v1.1 by local assessment Assess the number of subjects with PFS defined as duration of time from start of combination treatment to date of progression.
Measured: Up to 24 months
Phase 2a/Expansion
To assess overall survival (OS).
Measured: Up to 24 months
Phase 2a/Expansion
To assess duration of response (DOR) according to RECIST v1.1 by local assessment.
Measured: Up to 24 months
Phase 2a/Expansion
To assess clinical benefit rate (CBR) according to RECIST v1.1 by local assessment.
Measured: Up to 24 months
Phase 2a/Expansion
Maximum observed plasma concentration (Cmax) of AFM24.
Measured: 28 days starting on cycle 1 day 1
Phase 2a/Expansion
Time to maximum plasma concentration (Tmax) of AFM24.
Measured: 28 days starting on cycle 1 day 1
Phase 2a/Expansion
Minimum plasma concentration (Cmin) of AFM24.
Measured: 28 days starting on cycle 1 day 1
Phase 2a/Expansion
Area under plasma concentration-time curve for dosing interval (AUCtau) of AFM24.
Measured: 28 days starting on cycle 1 day 1
Phase 2a/Expansion
Immunogenicity of AFM24 when AFM24 is given in combination with SNK01 Frequency of subjects developing AFM24 ADAs and frequency of subjects developing neutralizing ADAs.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start3 Nov 2021
- Primary completion21 Sep 2023
- Study completion21 Sep 2023
Why it stopped: Affimed and NKGen have mutually decided to discontinue the study. Affimed will evaluate the best options to advance this project with an allogeneic off-the-shelf NK cell product while NKGen will focus on CNS with SNK01.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of Head and NeckStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Subjects will be enrolled sequentially in cohorts of 3 to 6 subjects into Phase 1/dose escalation. The dose escalation will follow the standard oncology Phase 1 3 + 3 dose escalation design. A minimum of 3 cohorts will be utilized and dose increases will be determined by the Safety Review Committee. Once RP2D is determined in Phase 1/dose escalation, the Phase 2a/expansion phase will begin enrolling up to 121 subjects.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- NKGen Biotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Affimed GmbH
- Responsible party
- Sponsor
- Investigators
- Paul Chang, MPH, Study director, NKGen Biotech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099549
- Sponsor's protocol ID
- AFM24-SNK01-103
- Status last verified
- Jul 2023
- First submitted
- 18 Oct 2021
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a, Open-Label, Multi-Center Study Evaluating the Safety, Tolerability, and Anti-Tumor Activity of AFM24 in Combination With Ex Vivo Expanded Autologous Natural Killer Cells (SNK01) in Subjects With Advanced/Metastatic EGFR-Expressing Cancers
- ClinicalTrials.gov ID
- NCT05099549
- Acronym / sponsor ID
- AFM24-SNK01-103
- Conditions
- Squamous Cell Carcinoma of Head and Neck, Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Advanced Solid Tumor, Refractory Tumor, Metastatic Tumor
- Keywords
- EGFR Positive, EGFR, EGFR+, AFM24, SNK01, Solid tumor, Lung cancer, Refractory
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Affimed and NKGen have mutually decided to discontinue the study. Affimed will evaluate the best options to advance this project with an allogeneic off-the-shelf NK cell product while NKGen will focus on CNS with SNK01.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- NKGen Biotech, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Affimed GmbH
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 21 Sep 2023 (actual)
- Study completion
- 21 Sep 2023 (actual)
- First posted
- 29 Oct 2021 (actual)
- 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.
This is an open-label, multi-center study to evaluate the safety, tolerability, and anti-tumor activity of SNK01 in combination with AFM24 in subjects with advanced or metastatic EGFR-expressing cancers.
Detailed description
The study will be conducted in two phases. The Phase 1/dose escalation phase will gather preliminary safety and tolerability data for escalating doses of AFM24 in combination with SNK01 at a fixed dose in order to determine the MTD/RP2D for the combination dose regimen to be used in the Phase 2a/expansion.
The Phase 2a/expansion portion of the study will gather additional safety, tolerability, efficacy, and anti-tumor activity information for the combination of AFM24 with SNK01 in subjects with three types of advanced or metastatic EGFR-expressing cancers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Subjects will be enrolled sequentially in cohorts of 3 to 6 subjects into Phase 1/dose escalation. The dose escalation will follow the standard oncology Phase 1 3 + 3 dose escalation design. A minimum of 3 cohorts will be utilized and dose increases will be determined by the Safety Review Committee. Once RP2D is determined in Phase 1/dose escalation, the Phase 2a/expansion phase will begin enrolling up to 121 subjects.
| Arm | Type | Receives |
|---|---|---|
| Phase 1, Dose Escalation | Experimental | Drug: AFM24, Biological: SNK01It is estimated that approximately 3-6 subjects will be enrolled per cohort in three dose cohorts for a total of 12-18 participants. SNK01 (fixed dose) will be administered weekly by IV infusion. |
| Phase 2a, Expansion Cohort 1 - Metastatic colorectal cancer (EXP-1: mCRC) | Experimental | Drug: AFM24, Biological: SNK01SNK01 (fixed dose) will be administered weekly by IV infusion. |
| Phase 2a, Expansion Cohort 2 - Head and Neck Squamous Cell Carcinoma (EXP-2: SCCHN) | Experimental | Drug: AFM24, Biological: SNK01SNK01 (fixed dose) will be administered weekly by IV infusion. |
| Phase 2a, Expansion Cohort 3 - Non-small cell lung cancer (EXP-3: NSCLC) | Experimental | Drug: AFM24, Biological: SNK01SNK01 (fixed dose) will be administered weekly by IV infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Capable of giving signed informed consent
- Males and females age ≥ 18 years
- Phase 1/Dose Escalation : any histologically confirmed advanced or metastatic EGFR-positive malignancy for which all standard of care treatment options have been received and are no longer effective or are considered inappropriate at the discretion of the investigator.
- Phase 2a/Expansion : histologically confirmed advanced or metastatic EGFR positive malignancy of mCRC (EXP-1 cohort), SCCHN (EXP-2 cohort) or NSCLC (EXP-3 cohort).
- Additional Criteria for Phase 2a/Expansion: subjects must have a disease history specific to their disease as listed below:
Key exclusion criteria (13 listed)
- Superior vena cava syndrome contra-indicating hydration
- Untreated or symptomatic central nervous system (CNS) metastases
- No resolution of specific toxicities related to any prior anti-cancer therapy to Grade ≤ 1 according to the NCI-CTCAE v.5.0 (except peripheral or motor neuropathy, lymphopenia and alopecia)
- Treatment with systemic anticancer therapy or an investigational device within 4 weeks (6 weeks if therapy was mitomycin C and/or nitrosoureas), or within 5 half-lives of the agent (if half-life is known and it is shorter) before the first dose of study treatment.
- Radiation therapy within 2 weeks before first dose of any study treatment or unresolved (NCI CTCAE v5.0 Grade > 1) toxicity from previous radiotherapy
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 |
|---|---|---|
| AFM24Tetravalent, bispecific EGFR- and CD16A-binding innate cell engager. | Drug | Phase 1, Dose Escalation, Phase 2a, Expansion Cohort 1 - Metastatic colorectal cancer (EXP-1: mCRC), Phase 2a, Expansion Cohort 2 - Head and Neck Squamous Cell Carcinoma (EXP-2: SCCHN), Phase 2a, Expansion Cohort 3 - Non-small cell lung cancer (EXP-3: NSCLC) |
| SNK01Patient-specific ex-vivo expanded autologous natural killer cells. | Biological | Phase 1, Dose Escalation, Phase 2a, Expansion Cohort 1 - Metastatic colorectal cancer (EXP-1: mCRC), Phase 2a, Expansion Cohort 2 - Head and Neck Squamous Cell Carcinoma (EXP-2: SCCHN), Phase 2a, Expansion Cohort 3 - Non-small cell lung cancer (EXP-3: NSCLC) |
Primary outcome
Phase 1/Dose Escalation
Time frame: 28 days starting on cycle 1 day 1
Determine the maximum tolerated dose (MTD) of AFM24 in combination with SNK01. To be assessed by the incidence and severity of dose-limiting toxicity (DLT) within the DLT observation period.
Phase 1/Dose Escalation
Time frame: 28 days starting on cycle 1 day 1
Determine the recommended phase 2 dose (RP2D) of AFM24 in combination with SNK01. To be assessed by the incidence and severity of dose-limiting toxicity (DLT) within the DLT observation period.
Phase 2a/Expansion
Time frame: Up to 24 months
Determine objective response rate (ORR) of AFM24 in combination with SNK01. Determine ORR using Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1
17 secondary outcomes
Phase 1/Dose Escalation
Time frame: Up to 24 months
Phase 1/Dose Escalation
Time frame: Up to 24 months
Phase 1/Dose Escalation
Time frame: 28 days starting on cycle 1 day 1
Phase 1/Dose Escalation
Time frame: 28 days starting on cycle 1 day 1
Phase 1/Dose Escalation
Time frame: 28 days starting on cycle 1 day 1
Phase 1/Dose Escalation
Time frame: 28 days starting on cycle 1 day 1
Phase 1/Dose Escalation
Time frame: Up to 24 months
Phase 2a/Expansion
Time frame: Up to 24 months
Phase 2a/Expansion
Time frame: Up to 24 months
Phase 2a/Expansion
Time frame: Up to 24 months
Phase 2a/Expansion
Time frame: Up to 24 months
Phase 2a/Expansion
Time frame: Up to 24 months
Phase 2a/Expansion
Time frame: 28 days starting on cycle 1 day 1
Phase 2a/Expansion
Time frame: 28 days starting on cycle 1 day 1
Phase 2a/Expansion
Time frame: 28 days starting on cycle 1 day 1
Phase 2a/Expansion
Time frame: 28 days starting on cycle 1 day 1
Phase 2a/Expansion
Time frame: Up to 24 months
Results and safety
The study was stopped early (reason given: Affimed and NKGen have mutually decided to discontinue the study. Affimed will evaluate the best options to advance this project with an allogeneic off-the-shelf NK cell product while NKGen will focus on CNS with SNK01.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
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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.
Paul Chang, MPH study director
NKGen Biotech, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AFM24 and SNK01 in people with Squamous Cell Carcinoma of Head and Neck and Carcinoma, Non-Small-Cell Lung, run by NKGen Biotech, Inc. 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 11 inclusion and 13 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 1 Mar 2024. 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 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 stopped early (reason given: Affimed and NKGen have mutually decided to discontinue the study. Affimed will evaluate the best options to advance this project with an allogeneic off-the-shelf NK cell product while NKGen will focus on CNS with SNK01.). Results are not available in the source record.
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?
Phase 1/Dose Escalation (time frame: 28 days starting on cycle 1 day 1). The study lists 3 primary outcomes in all. 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 1 Mar 2024.