Carcinoma, Non-Small-Cell Lung CancerPhase 1NCT06069570
Safety Study for a Gamma Delta T Cell Product Used With Low Dose Radiotherapy in Patients With Locally Advanced or Metastatic NSCLC or Solid Tumors With Bone Metastases
A Phase 1 study testing KB-GDT-01 in people with Carcinoma, Non-Small-Cell Lung Cancer and Bone Metastases From Solid Tumors, run by Kiromic BioPharma Inc. at 5 sites in United States.
Trial summary
This is a clinical trial studying intravenous infusions of allogeneic gamma delta T cells after receiving low dose radiotherapy in participants with locally advanced or metastatic non-small cell lung cancer or solid tumors with bone metastases to evaluate the safety and efficacy of combining immunotherapy with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung Cancer, Bone Metastases From Solid Tumors
- What is being tested?
- KB-GDT-01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 5 sitesUnited States
- Study dates
- 7 Nov 2023to Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Signed and dated informed consent form.
- Male or female, > 18 years old.
- Minimum body weight of 50 kilograms (kg).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC or locally advanced or metastatic solid tumor with bone metastasis
- Progressed on SOC therapy including platinum-based chemotherapy and immune checkpoint inhibitors (NSCLC), and are not a candidate for further standard anti-neoplastic therapy and/or have exhibited intolerance to and/or declined clinically applicable salvage therapies, and/or have declined therapy.
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- Genomic screening, with tumors with known actionable molecular alterations, such as EGFR, ALK, ROS-1, BRAF, RET, MET, and KRAS etc., must have progressed on appropriate target-directed molecular therapy.
- At least one measurable target lesion based on RECIST v1.1 confirmed by radiological imaging. Participants with isolated bone metastases are eligible for enrollment are not required to have measurable disease
- All toxicity associated with previous treatments are recovered to CTCAE grade of ≤1, except for continuing alopecia.
- Adequate hematopoietic, hepatic and renal function
- Agree to adequate contraception for up to 120 days after the last dose of study drug.
- Negative serum pregnancy test for women of childbearing potential
- All primary and metastatic disease sites are amenable to LDRT
- For solid tumors with bone metastases subjects (Part 2 Cohort B): receiving zoledronic acid for solid tumors with bone metastases
Who cannot join
- Chemotherapy, investigational, and/or check-point inhibitor therapy within the 30 days prior to study Day 1.
- Major surgery, except for vascular access placement, within the 30 days prior to study Day 1.
- Active autoimmune disease requiring immunosuppressive therapy.
- Infection requiring systemic treatment within 30 days prior to study Day 1.
- History of peritoneal effusion (ascites), pericardial, or pleural effusions/nodules.
- Uncontrolled hypertension, history of arrhythmia including atrial fibrillation, unstable angina, decompensated congestive heart failure, cardiac ejection fraction ≤ 50%, myocardial infarction, or marked baseline prolonged QT/QTc intervals.
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- Human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C detection.
- Participation in the treatment portion of a clinical trial or completed a clinical trial within the 30 days prior to the first dose of KB-GDT-01.
- Presence of any condition that may, in the opinion of the Investigator, render the patient inappropriate from participating in the study.
- Breastfeeding or pregnant female, or patient is expecting to conceive or father children during the study.
- Allergy or intolerance to any of the study product ingredients or excipients.
- Live vaccines administered within 30 days prior to study Day 1.
- Individuals lacking capacity to consent for themselves.
- Superior vena cava obstruction
- Prior radiation therapy to a selected LDRT treatment site </= 30 days prior to Day 1.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Beverly Hills Cancer Center
Beverly Hills, California, 90211
Ali Muhammad, (310) 432-8934, amuhammad@bhcancercenter.com
Afshin Gabayan, MD
- Recruiting
Virginia Oncology Associates
Norfolk, Virginia, 23502
Karen McClain, (757) 213-5658, Karen.mcclain@usoncology.com
Gary Simmons, DO, MSHA
- Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
IDDC Referrals, (878) 261 6063, IDDCReferrals@upmc.edu
Jason Luke, MD
- Not yet recruiting
The University of Arizona Cancer Center
Tucson, Arizona, 85719
Mikayla Kirby, (520) 621-9656, mikaylakirby@arizona.edu
Margaret Ramirez, (520) 626-3677, ramirezm1@arizona.edu
- Recruiting
Texas Oncology - Tyler
Tyler, Texas, 75702
Jennifer Castner, (903) 579-9800, Jennifer.castner@usoncology.com
Donald Richards, MD, PhD
About this study
Official title: Phase 1 Trial Evaluating the Safety and Tolerability of Gamma Delta T-Cell Infusions in Combination With Low Dose Radiotherapy in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer or Solid Tumors With Bone Metastases
This is a clinical trial studying intravenous infusions of allogeneic gamma delta T cells after receiving low dose radiotherapy in participants with locally advanced or metastatic non-small cell lung cancer or solid tumors with bone metastases to evaluate the safety and efficacy of combining immunotherapy with radiation therapy.
Read the detailed description
In this clinical trial, or 'study', participants with locally advanced or metastatic, non-small cell cancer (NSCLC) or solid tumors with bone metastases, will receive KB-GDT-01, an allogeneic (cells from healthy donors) gamma delta T-cell product. All participants will receive KB-GDT-01 as intravenous infusions in combination with radiotherapy.
After being informed about the study and its potential risks, during the 28-day screening period, all consented participants will have laboratory tests, assessments, tumor scans, and a tumor biopsy.
Cytokine release syndrome symptoms and other potential adverse effects, will be monitored during the dose limiting toxicity period.
The study will be conducted in 2 parts, with the same number of visits in each part.
In Part 1 Dose Escalation, the study will attempt to identify the best dose with the lowest incidence of adverse effects (AE) and try to identify if the KB-GDT-01 is working (effectiveness). In Part 2 Dose Expansion the best dose will be further investigated for AE and effectiveness. There will be up to 36 participants in Part 1 and up to 21 additional participants in Part 2 of the study.
The total treatment period of the study drug protocol will be completed in 31 days. Participants will then attend clinic visits during a 30-day short-term follow-up period, with a subsequent long-term follow-up period up to 12 months.
- Being tested
- KB-GDT-01
- Medical subject headings
- Carcinoma, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KB-GDT-01Biological
Also called Low dose radiotherapy
KB-GDT-01 is an allogeneic, gamma delta T-cell suspension product manufactured from the isolation of healthy donor peripheral blood mononuclear cells (PBMC). The KB-GDT-01 cells are cryopreserved in vapor phase liquid nitrogen (LN2) in 50 mL CryoMACS® cryobags for a total of 200 × 106 viable cells/bag. The KB-GDT-01 cryopreserved product is thawed and administered intravenously (IV) until the entire bag is infused by gravity. Low dose radiotherapy (LDRT) will be administered to selected tumor sites (maximum of 5 isocenters) at 1.0 Gy/fraction on Days 1 and 2, followed by the KB-GDT-01 IV infusion on Day 3. LDRT will be repeated on Days 8 and 9, and the 2nd KB-GDT-01 IV infusion on Day 10.
| Study group | Role | What they receive |
|---|---|---|
| KB-GDT-01 cells | Experimental | Dose Level 1: 400 x10^6, 800 x10^6 or 1600 x10^6 KB-GDT-01 cells + radiation (1.0 Gy/fraction) Receives: Biological: KB-GDT-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events (AE) and/or Dose Limiting Toxicities (DLT) as a Measurement of Safety and Tolerability of KB-GDT-01 in Combination with LDRT
DLT, defined as the occurrence or start of a clinically significant Grade 3 or greater AE (per CTCAE v5.0) occurring during the DLT assessment period that cannot be attributed to disease progression, intercurrent illness, or concomitant medication.
Measured: From the first infusion of study drug until Day 40 or 30 days after the last study drug infusion, whichever occurs later
Secondary outcomes (6)
Objective Response Rate (ORR)
Investigator assessed ORR per RECIST v1.1. ORR is defined as the percentage of participants with a best overall response of complete or partial response.
Measured: From first study drug infusion through to Month 24
Progression Free Survival (PFS)
Investigator assessed PFS per RECIST v1.1. PFS is defined as the time from first study drug infusion until the first evidence of disease progression or death.
Measured: From first study drug infusion until the first evidence of disease progression, death or Month 24.
Overall Survival (OS)
Investigator assessed OS per RECIST v1.1. OS is defined as the time from first study drug infusion to death.
Measured: From first study drug infusion until death or Month 24.
Time to Progression (TTP)
Investigator assessed TTP per RECIST v1.1. TTP is defined as the time from first study drug infusion until first evidence of disease progression.
Measured: From first study drug infusion until first evidence of disease progression or Month 24.
Time to Treatment Response (TTR)
Investigator assessed TTR per RECIST v1.1. TTR is defined as the time from first study drug infusion until first evidence of disease response.
Measured: From first study drug infusion until first evidence of disease response or Month 24.
Disease Control Rate (DCR)
Investigator assessed DCR per RECIST v1.1 DCR is defined as the percentage of participants with complete response, partial response or stable disease.
Measured: From first study drug infusion until first evidence of disease response or stable disease or Month 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start7 Nov 2023
- Primary completionOct 2025 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell Lung CancerStudies 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
- Not applicable
- Intervention model
- Sequential
- Model description
- The maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) or the maximum administered dose (MAD) will be determined based on isotonic regression in Part 1 Dose Escalation. If the MTD/MAD shows an acceptable safety and tolerability profile, an additional 12 participants in Part 2 expansion will be enrolled. Three dose levels of KB-GDT-01 will be evaluated and will follow a Bayesian Optimal Interval (BOIN) design rule based on a targeting rate of 25% for dose limiting toxicity (DLT) occurring between the first KB-GDT-01 infusion and Day 40. Depending on observed DLT rate, the safety monitoring committee will assess whether to escalate to the next dose, de-escalate (not applicable for the first dose), hold at current dose or stop the study if at the first dose.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kiromic BioPharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stiris Research Inc
- Responsible party
- Sponsor
- Investigators
- Jason J Luke, MD, FACP, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06069570
- Sponsor's protocol ID
- DELTACEL-01
- Status last verified
- Mar 2025
- First submitted
- 29 Sep 2023
- Last updated
- 5 Mar 2025
- Results posted
- No
- 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 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Trial Evaluating the Safety and Tolerability of Gamma Delta T-Cell Infusions in Combination With Low Dose Radiotherapy in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer or Solid Tumors With Bone Metastases
- ClinicalTrials.gov ID
- NCT06069570
- Acronym / sponsor ID
- DELTACEL-01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Kiromic BioPharma Inc.Industry (pharma, biotech, devices)
- Collaborators
- Stiris Research Inc
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 6 Oct 2023 (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 a clinical trial studying intravenous infusions of allogeneic gamma delta T cells after receiving low dose radiotherapy in participants with locally advanced or metastatic non-small cell lung cancer or solid tumors with bone metastases to evaluate the safety and efficacy of combining immunotherapy with radiation therapy.
Detailed description
In this clinical trial, or 'study', participants with locally advanced or metastatic, non-small cell cancer (NSCLC) or solid tumors with bone metastases, will receive KB-GDT-01, an allogeneic (cells from healthy donors) gamma delta T-cell product. All participants will receive KB-GDT-01 as intravenous infusions in combination with radiotherapy.
After being informed about the study and its potential risks, during the 28-day screening period, all consented participants will have laboratory tests, assessments, tumor scans, and a tumor biopsy.
Cytokine release syndrome symptoms and other potential adverse effects, will be monitored during the dose limiting toxicity period.
The study will be conducted in 2 parts, with the same number of visits in each part.
In Part 1 Dose Escalation, the study will attempt to identify the best dose with the lowest incidence of adverse effects (AE) and try to identify if the KB-GDT-01 is working (effectiveness). In Part 2 Dose Expansion the best dose will be further investigated for AE and effectiveness. There will be up to 36 participants in Part 1 and up to 21 additional participants in Part 2 of the study.
The total treatment period of the study drug protocol will be completed in 31 days. Participants will then attend clinic visits during a 30-day short-term follow-up period, with a subsequent long-term follow-up period up to 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) or the maximum administered dose (MAD) will be determined based on isotonic regression in Part 1 Dose Escalation. If the MTD/MAD shows an acceptable safety and tolerability profile, an additional 12 participants in Part 2 expansion will be enrolled. Three dose levels of KB-GDT-01 will be evaluated and will follow a Bayesian Optimal Interval (BOIN) design rule based on a targeting rate of 25% for dose limiting toxicity (DLT) occurring between the first KB-GDT-01 infusion and Day 40. Depending on observed DLT rate, the safety monitoring committee will assess whether to escalate to the next dose, de-escalate (not applicable for the first dose), hold at current dose or stop the study if at the first dose.
| Arm | Type | Receives |
|---|---|---|
| KB-GDT-01 cells | Experimental | Biological: KB-GDT-01Dose Level 1: 400 x10^6, 800 x10^6 or 1600 x10^6 KB-GDT-01 cells + radiation (1.0 Gy/fraction) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Signed and dated informed consent form.
- Male or female, > 18 years old.
- Minimum body weight of 50 kilograms (kg).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC or locally advanced or metastatic solid tumor with bone metastasis
Key exclusion criteria (15 listed)
- Chemotherapy, investigational, and/or check-point inhibitor therapy within the 30 days prior to study Day 1.
- Major surgery, except for vascular access placement, within the 30 days prior to study Day 1.
- Active autoimmune disease requiring immunosuppressive therapy.
- Infection requiring systemic treatment within 30 days prior to study Day 1.
- History of peritoneal effusion (ascites), pericardial, or pleural effusions/nodules.
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 |
|---|---|---|
| KB-GDT-01Also: Low dose radiotherapyKB-GDT-01 is an allogeneic, gamma delta T-cell suspension product manufactured from the isolation of healthy donor peripheral blood mononuclear cells (PBMC). The KB-GDT-01 cells are cryopreserved in vapor phase liquid nitrogen (LN2) in 50 mL CryoMACS® cryobags for a total of 200 × 106 viable cells/bag. The KB-GDT-01 cryopreserved product is thawed and administered intravenously (IV) until the entire bag is infused by gravity. Low dose radiotherapy (LDRT) will be administered to selected tumor sites (maximum of 5 isocenters) at 1.0 Gy/fraction on Days 1 and 2, followed by the KB-GDT-01 IV infusion on Day 3. LDRT will be repeated on Days 8 and 9, and the 2nd KB-GDT-01 IV infusion on Day 10. | Biological | KB-GDT-01 cells |
Primary outcome
Number of participants with Adverse Events (AE) and/or Dose Limiting Toxicities (DLT) as a Measurement of Safety and Tolerability of KB-GDT-01 in Combination with LDRT
Time frame: From the first infusion of study drug until Day 40 or 30 days after the last study drug infusion, whichever occurs later
DLT, defined as the occurrence or start of a clinically significant Grade 3 or greater AE (per CTCAE v5.0) occurring during the DLT assessment period that cannot be attributed to disease progression, intercurrent illness, or concomitant medication.
6 secondary outcomes
Objective Response Rate (ORR)
Time frame: From first study drug infusion through to Month 24
Progression Free Survival (PFS)
Time frame: From first study drug infusion until the first evidence of disease progression, death or Month 24.
Overall Survival (OS)
Time frame: From first study drug infusion until death or Month 24.
Time to Progression (TTP)
Time frame: From first study drug infusion until first evidence of disease progression or Month 24.
Time to Treatment Response (TTR)
Time frame: From first study drug infusion until first evidence of disease response or Month 24.
Disease Control Rate (DCR)
Time frame: From first study drug infusion until first evidence of disease response or stable disease or Month 24.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
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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.
Jason J Luke, MD, FACP principal investigator
University of Pittsburgh
5 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 KB-GDT-01 in people with Carcinoma, Non-Small-Cell Lung Cancer and Bone Metastases From Solid Tumors, run by Kiromic BioPharma Inc. at 5 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 14 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Wagener, BS (1-844-539-2873, mwagener@kiromic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse Events (AE) and/or Dose Limiting Toxicities (DLT) as a Measurement of Safety and Tolerability of KB-GDT-01 in Combination with LDRT (time frame: From the first infusion of study drug until Day 40 or 30 days after the last study drug infusion, whichever occurs later). 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 5 Mar 2025.