SCLCEarly Phase 1NCT04677361
Feasibility Study on Expandion of MILs From NSCLC and SCLC Patients and Infusion With Pembrolizumab
A Early Phase 1 study testing MILs™ in Combination with Pembrolizumab in people with SCLC and NSCLC, run by Fox Chase Cancer Center.
Trial summary
Marrow infiltrating lymphocytes (MILs™) are a novel method of adoptive cell therapy that provide an activated, polyclonal population of autologous tumor-specific T cells derived from the bone marrow. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- MILs™ in Combination with Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Oct 2024
- Phase
- Early Phase 1
- 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
- Age > 18 years.
- Patients must have histologically or cytologically confirmed SCLC or NSCLC.
- Patients who have undergone chemotherapy must have had last dose ≥21 days prior to BMA; subjects who are currently being treated, bone marrow may be collected between cycles (prior to Day 1 of the next cycle).
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 prior to BMA collection.
- Willingness to complete a BMA.
- Patients must have adequate bone marrow function prior to BMA collection:
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- Platelet count ≥ 100 × 109/L
- Absolute neutrophil count (ANC) ≥ 1.0 ×109/L
- Lymphocyte count ≥ 0.5 ×109/L
- Patients must not have any history of coagulopathy or prothrombin time (PT)/partial thromboplastin time (PTT) > 2x upper limit of normal (ULN)(unless on an anticoagulant). If the patient is on an anticoagulant, it should be halted for 5 days prior to the BMA and PT/PTT < 2x ULN by the day of the procedure.
- Ability to understand and willingness to sign a written informed consent and HIPAA consent document.
Who cannot join
- Prior hematopoietic stem cell transplantation.
- History of another primary malignancy that has been diagnosed or required therapy within the past 2 years prior to BMA collection (except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast).
- Infection requiring treatment with antibiotics, antifungal, or antiviral agents within 7 days before the BMA.
- Presence of an autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosis) requiring active systemic treatment. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are not excluded.
- Clinically significant, uncontrolled cardiovascular disease, including congestive heart failure Grade III or IV according to the New York Heart Association classification, myocardial infarction, or unstable angina within the previous 6 months prior to BMA collection.
- Major surgical procedure within 7 days of BMA. Procedures such as central venous catheter placement, tumor needle biopsy, and feeding tube placement are not considered major surgical procedures.
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- Administration of neutrophil growth factor support within 14 days prior to the BMA.
- Prior radiation to both sides of the pelvis. Prior radiation to one side of the pelvis is permitted as long as the other side has not received radiation and is solely use to collect the bone marrow aspiration.
- Use of systemic corticosteroids (glucocorticoids) for greater than one day within 28 days prior to the BMA. However, if a patient has an IV contrast allergy for CT, steroids should be used according to the institutional guidelines for contrast dye allergy.
- Known diagnosis of human immunodeficiency virus (HIV) or active viral hepatitis, testing is not required.
- Breast feeding females or pregnant females as documented by a serum beta human chorionic gonadotropin (β-hCG) pregnancy test consistent with pregnancy, obtained within 72 hours of BMA. Refer to section 5.4 for further detail.
- Unwilling or unable to comply with the protocol (e.g., scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions)
- Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the Investigator's opinion, could affect the safety of the subject.
About this study
Official title: A Pilot Study to Assess the Feasibility of Expanding Marrow Infiltrating Lymphocytes (MILs™) From Bone Marrow in Non-Small Cell Lung Cancer (NSCLC) and Small Cell Lung Cancer (SCLC) and Subsequently the Efficacy and Safety of MILs™ in Combination With Pembrolizumab in Patients With NSCLC and SCLC
Marrow infiltrating lymphocytes (MILs™) are a novel method of adoptive cell therapy that provide an activated, polyclonal population of autologous tumor-specific T cells derived from the bone marrow. MILs™ in this study will be used to treat small cell lung cancer (SCLC) that has become resistant to chemotherapy and radiation.
Read the detailed description
Small cell lung cancer (SCLC) is generally treated with surgery or chemotherapy, with or without radiation therapy, depending on staging. The problem with current available treatments is that SCLC almost always becomes resistant to chemotherapy and radiation. Marrow infiltrating lymphocytes (MILs™) are a novel method of adoptive cell therapy that provide an activated, polyclonal population of autologous tumor-specific T cells derived from bone marrow. Prior to treatment of MILs™ patients will receive non-myeloablative lymphodepletion with cyclophosphamide and fludarabine to increase the efficacy of adoptive T cell therapy. Bone marrow aspirate (BMA) will be collected from the patient to manufacture the MILs™. Upon progression and after the bone marrow is collected, a subject may receive bridging treatment of pembrolizumab until the MILs™ are received, after which treatment of the MILs™ and pembrolizumab will begin.
- Being tested
- MILs™ in Combination with Pembrolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MILs™ in Combination with PembrolizumabCombination product
Efficacy and Safety of MILs™ in Combination with Pembrolizumab in Patients with NSCLC and SCLC
| Study group | Role | What they receive |
|---|---|---|
| MILs™ in Combination with Pembrolizumab | Experimental | Each patient will have their bone marrow collected, MILs produced, and the patient will be dosed with all of the MILs produced for that individual patient. The minimum requirement for treatment is 2 x 108 cells. The MILs™ must be administered via a central catheter which could either be a PICC line, port or central line.
Subjects will be treated with MILs™ and pembrolizumab (200 mg Q3W) combination. MILs™ will be administered on Day 0 and pembrolizumab administered on Day 1. Pembrolizumab will be administered as a 30 minute IV infusion with a window of -5 minutes and +10 minutes is permitted. Receives: Combination Product: MILs™ in Combination with Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the safety of infusion of MILs™ by Adverse Events per
To assess the safety and tolerability of MILs™ in patients with NSCLC and SCLC
Measured: 2 years
Secondary outcomes (2)
Progression free survival (PFS) in patients as the length of time from the day of MILs™ administration to progression of the disease
To determine the efficacy per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 of MILs™ + pembrolizumab administration in patients with NSCLC and SCLC
Measured: 2 years
Overall response rate (ORR) as the portion of patients with a tumor size reduction from the time of MILs™ administration to the time first response is seen in patients, whether it is partial response (PR) or complete response (CR
To determine the efficacy per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 of MILs™ + pembrolizumab administration in patients with NSCLC and SCLC
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study startOct 2021 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionOct 2024 (estimated)
Why it stopped: Grantor shifted focus in disease, funding was stopped
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCLCStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prior to treatment of MILs™ patients will receive non-myeloablative lymphodepletion with cyclophosphamide and fludarabine to increase the efficacy of adoptive T cell therapy. Bone marrow aspirate (BMA) will be collected from the patient to manufacture the MILs™. Upon progression and after the bone marrow is collected, a subject may receive bridging treatment of pembrolizumab until the MILs™ are received, after which treatment of the MILs™ and pembrolizumab will begin.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- WindMIL Therapeutics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677361
- Sponsor's protocol ID
- TH-161
- Other IDs
- 20-1031
- Status last verified
- Oct 2021
- First submitted
- 17 Dec 2020
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Feasibility of Expanding Marrow Infiltrating Lymphocytes (MILs™) From Bone Marrow in Non-Small Cell Lung Cancer (NSCLC) and Small Cell Lung Cancer (SCLC) and Subsequently the Efficacy and Safety of MILs™ in Combination With Pembrolizumab in Patients With NSCLC and SCLC
- ClinicalTrials.gov ID
- NCT04677361
- Acronym / sponsor ID
- TH-161
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Grantor shifted focus in disease, funding was stopped
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- WindMIL Therapeutics
- Study start
- Oct 2021 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 21 Dec 2020 (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.
Marrow infiltrating lymphocytes (MILs™) are a novel method of adoptive cell therapy that provide an activated, polyclonal population of autologous tumor-specific T cells derived from the bone marrow. MILs™ in this study will be used to treat small cell lung cancer (SCLC) that has become resistant to chemotherapy and radiation.
Detailed description
Small cell lung cancer (SCLC) is generally treated with surgery or chemotherapy, with or without radiation therapy, depending on staging. The problem with current available treatments is that SCLC almost always becomes resistant to chemotherapy and radiation. Marrow infiltrating lymphocytes (MILs™) are a novel method of adoptive cell therapy that provide an activated, polyclonal population of autologous tumor-specific T cells derived from bone marrow. Prior to treatment of MILs™ patients will receive non-myeloablative lymphodepletion with cyclophosphamide and fludarabine to increase the efficacy of adoptive T cell therapy. Bone marrow aspirate (BMA) will be collected from the patient to manufacture the MILs™. Upon progression and after the bone marrow is collected, a subject may receive bridging treatment of pembrolizumab until the MILs™ are received, after which treatment of the MILs™ and pembrolizumab will begin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prior to treatment of MILs™ patients will receive non-myeloablative lymphodepletion with cyclophosphamide and fludarabine to increase the efficacy of adoptive T cell therapy. Bone marrow aspirate (BMA) will be collected from the patient to manufacture the MILs™. Upon progression and after the bone marrow is collected, a subject may receive bridging treatment of pembrolizumab until the MILs™ are received, after which treatment of the MILs™ and pembrolizumab will begin.
| Arm | Type | Receives |
|---|---|---|
| MILs™ in Combination with Pembrolizumab | Experimental | Combination Product: MILs™ in Combination with PembrolizumabEach patient will have their bone marrow collected, MILs produced, and the patient will be dosed with all of the MILs produced for that individual patient. The minimum requirement for treatment is 2 x 108 cells. The MILs™ must be administered via a central catheter which could either be a PICC line, port or central line. Subjects will be treated with MILs™ and pembrolizumab (200 mg Q3W) combination. MILs™ will be administered on Day 0 and pembrolizumab administered on Day 1. Pembrolizumab will be administered as a 30 minute IV infusion with a window of -5 minutes and +10 minutes is permitted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age > 18 years.
- Patients must have histologically or cytologically confirmed SCLC or NSCLC.
- Patients who have undergone chemotherapy must have had last dose ≥21 days prior to BMA; subjects who are currently being treated, bone marrow may be collected between cycles (prior to Day 1 of the next cycle).
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 prior to BMA collection.
- Willingness to complete a BMA.
Key exclusion criteria (13 listed)
- Prior hematopoietic stem cell transplantation.
- History of another primary malignancy that has been diagnosed or required therapy within the past 2 years prior to BMA collection (except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast).
- Infection requiring treatment with antibiotics, antifungal, or antiviral agents within 7 days before the BMA.
- Presence of an autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosis) requiring active systemic treatment. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are not excluded.
- Clinically significant, uncontrolled cardiovascular disease, including congestive heart failure Grade III or IV according to the New York Heart Association classification, myocardial infarction, or unstable angina within the previous 6 months prior to BMA collection.
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 |
|---|---|---|
| MILs™ in Combination with PembrolizumabEfficacy and Safety of MILs™ in Combination with Pembrolizumab in Patients with NSCLC and SCLC | Combination product | MILs™ in Combination with Pembrolizumab |
Primary outcome
Assess the safety of infusion of MILs™ by Adverse Events per
Time frame: 2 years
To assess the safety and tolerability of MILs™ in patients with NSCLC and SCLC
2 secondary outcomes
Progression free survival (PFS) in patients as the length of time from the day of MILs™ administration to progression of the disease
Time frame: 2 years
Overall response rate (ORR) as the portion of patients with a tumor size reduction from the time of MILs™ administration to the time first response is seen in patients, whether it is partial response (PR) or complete response (CR
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing MILs™ in Combination with Pembrolizumab in people with SCLC and NSCLC, run by Fox Chase Cancer Center.
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: withdrawn, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 withdrawn before enrolling participants, so there are no results.
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?
Assess the safety of infusion of MILs™ by Adverse Events per (time frame: 2 years). 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 8 Oct 2021.