Malignant Epithelial NeoplasmsPhase 1NCT04520711
Hotspot TCR-T: A Phase I/Ib Study of Adoptively Transferred T-cell Receptor Gene-engineered T Cells (TCR-T)
A Phase 1 study testing TCR-transduced T cells, CDX-1140 and Pembrolizumab in people with Malignant Epithelial Neoplasms, run by Providence Health & Services at 1 site in United States.
Trial summary
This is a phase I/Ib study of adoptively transferred T-cell receptor gene-engineered T cells (TCR-T) targeting tumor-specific antigens, with in vivo CD40 activation and PD-1 blockade, for patients with incurable cancers. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malignant Epithelial Neoplasms
- What is being tested?
- TCR-transduced T cells, CDX-1140 and Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2022to Feb 2027
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients 18 years and older with metastatic or locoregionally advanced epithelial cancers, that are considered incurable.
- Confirmation by Tran Laboratory of neoantigen-reactive TCR(s) suitable for TCR-gene therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
- Laboratory values:
- WBC ≥ 2000/uL
- Neutrophils ≥ 1000/uL
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- Hgb > 8.0 g/dl (patients may be transfused to reach this level)
- Platelets > 100,000 cells/mm3
- Creatinine ≤ 2.0 mg/dL
- AST \& ALT ≤ 2.5 × ULN
- Alkaline phosphatase ≤ 2.5 × ULN
- Total bilirubin ≤ 2 × ULN (except patients with Gilbert's syndrome, who must have a total bilirubin ≤ 3.0 mg/dL). If total bilirubin is >1.5, conjugated bilirubin must be ≤ ULN (conjugated bilirubin only needs to be tested if total bilirubin exceeds ULN). If there is no institutional ULN, then conjugated bilirubin must be < 40% of total bilirubin.
- Patients positive for hepatitis B core antibody (anti-HBc, total), are eligible only if HBV DNA is non- detectable by qPCR.
- Patients positive for hepatitis C virus (HCV) antibody are eligible only if HCV RNA is non-detectable by qPCR.
- Patients known positive for HIV 1/2 antibodies, are eligible if ARV treatment compliant with documented stable absolute CD4 count > 300 cells/mm3 for at least 6 months and undetectable viral load.
- Women of childbearing potential must have negative serum bHCG pregnancy test ≤ 24 hours prior to start of study treatment.
- Ability to give informed consent and comply with the protocol.
- Anticipated lifespan greater than 12 weeks.
- Men and women of childbearing potential must agree to take appropriate pregnancy precautions during treatment and through 180 days after last dose of study treatment. Patients and/or partners who are surgically sterile or postmenopausal (defined by 12 or more consecutive months with no menstruation, or surgically sterile) are exempt from this requirement. Males must agree not to donate sperm for at least 90 days after discontinuing study treatment.
Who cannot join
- Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
- Receipt of any investigational anticancer therapy during the last 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study treatment. Receipt of any prior anti-CD40 therapy.
- Any concurrent chemotherapy, biologic, or hormonal therapy for cancer treatment, within 21 days (6 weeks for nitrosoureas) or at least 5 half-lives (whichever is longer) prior to the first dose of study treatment. Concurrent use of 4. hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
- 5. Local treatment of isolated lesions for palliative intent is acceptable (e.g., local surgery or radiotherapy), excluding target lesions, Palliative radiation therapy cannot be administered less than 1 week prior to the first dose of study treatment.
- 6. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug. Participants must have recovered (to a grade 1 or lower) from all radiation-related toxicities, not require corticosteroids for this purpose and not have had radiation pneumonitis.
- 7. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of study treatment. Note: Local surgery of isolated lesions for palliative intent is acceptable.
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- 8. History of organ transplant, including allogeneic stem cell transplantation. 9. History of (non-infectious) pneumonitis/interstitial lung disease or current pneumonitis/interstitial lung disease, including grade 1 pneumonitis (asymptomatic; clinical or diagnostic observation only; intervention not indicated).
- 10. Uncontrolled intercurrent illness as deemed by the investigator, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, unstable cardiac arrhythmia, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
- 11. History of another primary malignancy except for:
- Malignancy treated with curative intent and with no known active disease ≥1 year before the first dose of investigational product and of low potential risk for recurrence.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease (per investigator discretion).
- Adequately treated carcinoma in situ without evidence of disease (per investigator discretion) 12. History of leptomeningeal carcinomatosis 13. Has untreated central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients whose brain metastases have been treated may participate provided they show radiographic stability (imaging at least four weeks apart showing no evidence of intracranial progression). In addition, any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have resolved or be stable either, without the use of steroids, or are stable on a steroid dose of ≤ 10mg/day of prednisone or its equivalent and anti-seizure medications for at least 14 days prior to the start of treatment. Patients on a stable dose of seizure medicines for epilepsy unrelated to cancer are eligible for the trial.
- 14. History of active primary immunodeficiency. 15. Active tuberculosis infection (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice).
- 16. Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (> 10 mg/day of prednisone or equivalent).:
- Autoimmune disease that is not active (in remission), but in the judgment of the investigator could risk substantial morbidity in the event of relapse, may be grounds for exclusion. This can include a prior history of pneumonitis or other autoimmune sequelae of prior immunotherapy.
- Physiologic corticosteroid replacement therapy at doses > 10 mg/day of prednisone or equivalent for adrenal or pituitary insufficiency and in the absence of active autoimmune disease is permitted.
- Participants with asthma that requires intermittent use of bronchodilators, inhaled steroids, or local steroid injections may participate.
- Participants using topical, ocular, intra-articular, or intranasal steroids (with minimal systemic absorption, per investigator discretion) may participate.
- 17. Brief courses of corticosteroids for prophylaxis (e.g., contrast dye allergy) or study treatment-related standard premedication are permitted.
- 18. Receipt of live attenuated vaccine within 28 days prior to the first dose of study treatment. Note: patients should not receive live vaccine during study treatment and up to 30 days after the last dose of study treatment.
- 19. Known allergy or hypersensitivity to study drug(s) or compounds of similar biologic composition to the study drug(s), or any of the study drug excipients.
- 20. Any unresolved NCI CTCAE Grade ≥2 toxicities from prior anti-cancer therapy (see above for radiotherapy consideration) with the exception of vitiligo or alopecia, and per investigator discretion for laboratory values not defined in the inclusion criteria.
- 21. Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Principal Investigator or one of the Co-Principal Investigators.
- 22. Patients with irreversible toxicity not reasonably expected to be exacerbated by study treatment may be included only after consultation with the Principal Investigator or one of the Co-Principal Investigators.
- 23. Immune-related toxicity during prior checkpoint inhibitor therapy for which permanent discontinuation of therapy is recommended (per product label or consensus guidelines) OR any immune-related toxicity requiring intensive or prolonged immunosuppression to manage (with the exception of endocrinopathy that is well controlled on replacement hormones).
- 24. Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension or arrhythmia, congestive heart failure (NYHA Class III or IV) related to primary cardiac disease, uncontrolled ischemic or severe valvular heart disease. Patients with a history of myocardial infarction, cerebral vascular accident, thrombosis or pulmonary embolus within 12 months prior to the first dose of study treatment are excluded from this study.
- 25. Any other acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with trial participation or trial drug administration or could interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into the trial.
- 26. Women who are pregnant, lactating or expecting to conceive, or men who father children within the projected duration of the study.
- 27. Unable or unwilling to comply with study requirements, including follow-up visits.
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence Portland Medical Center
Portland, Oregon, 97213
About this study
Official title: Hotspot TCR-T: A Phase I/Ib Study of Adoptively Transferred T-cell Receptor Gene-engineered T Cells (TCR-T) Targeting Tumor-Specific Neoantigens, With in Vivo CD40 Activation and PD-1 Blockade, for Patients With Incurable Cancers (2020000584)
This is a phase I/Ib study of adoptively transferred T-cell receptor gene-engineered T cells (TCR-T) targeting tumor-specific antigens, with in vivo CD40 activation and PD-1 blockade, for patients with incurable cancers. The study design is a safety lead-in TCR-T with CD40/PD-1 (3+3), followed by Simon's Two-Stage expansion design, 80% power and 5% one-sided alpha: stage-one futility assessment at n = 10; stage-two assessment at n = 22, (accrual up to 24 to allow for potential study drop-out).
Read the detailed description
Patients will be infused with T cells engineered to express TCRs targeting one to five tumor-specific antigens expressed by their autologous tumor. The number of T cells infused will range from 1e9 to 1e11. Monoclonal antibodies targeting PD-1 (pembrolizumab) and CD40 (CDX-1140, Celldex Therapeutics)43 will be administered, in that order, starting within 24 hours of cell infusion and re-administered at approximately 3 week intervals. Clinic visits will include longitudinal evaluation of toxicities and monitoring of immunological parameters. The presence or absence of replication competent retrovirus (RCR) will be evaluated for the first year following adoptive cell transfer, or longer, if there is evidence of RCR.
Tumor Response assessment by RECIST 1.1 is performed every 9-12 weeks. Study treatment continues until progression. Option repeat TCR-T infusion is allowed and in addition may incorporate preconditioning chemotherapy using a de-intensified non-myeloablative (NMA) regimen consisting of a single dose of gemcitabine and a single dose of either cyclophosphamide or epirubicin, designed to elicit immunogenic cell death and transient lymphopenia.
The primary objective of this study is to determine the safety of the adoptive transfer of TCR-gene engineered T cells targeting TSA in combination with CD40 and PD-1 immunotherapy. The secondary objective is to determine whether this therapy can mediate objective clinical responses as determined by objective criteria (e.g. RECIST 1.1). The study will also characterize the differentiation and functional state of the TCR-gene modified T cells before and after cell therapy and monitor their persistence in the patient after treatment. Up to 24 patients will be enrolled in this study. Based on published trials treating patients with TCR-transduced T cells, adverse events such as fever, chills, dyspnea, hypotension, fatigue, edema, rash, and rarely acute cytokine release syndrome, may occur.
Clinical and immunological data will be analyzed which will determine whether this therapy is safe and effective, and whether there are biomarkers or immunological signatures that correlate to efficacy and/or lack of efficacy. This data will determine whether additional studies are warranted.
- Conditions
- Malignant Epithelial Neoplasms
- Being tested
- TCR-transduced T cells, CDX-1140, Pembrolizumab
- Medical subject headings
- Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCR-transduced T cellsBiological
TSA-reactive TCR-engineered T cells
CDX-1140Drug
Recombinant fully human IgG2κ monoclonal antibody
PembrolizumabDrug
Humanized immunoglobulin G4 (IgG4) monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| CDX-1140 + TCR-T + Pembro | Experimental | Patients will receive CDX-1440, TCR-T, and pembrolizumab. Receives: Biological: TCR-transduced T cells; Drug: CDX-1140; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety, tolerability and DLTs of combinatorial adoptively transferred T-cell receptor gene-engineered T cells (TCR-T) with in vivo CD40 activation and PD-1 blockade, for patients with incurable cancers
Analysis of adverse events
Measured: 2 years
Secondary outcomes (4)
Objective response rate
percentage of subjects having CR or PR
Measured: 2 years
Duration of response
the time from the earliest date of disease response (CR or PR) until earliest date of disease progression or death due to any cause
Measured: 2 years
Clinical benefit rate
percentage of subjects having CR, PR, or SD (with minimum duration > 4 months)
Measured: 2 years
Overall survival
determined by survival follow-up
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 posted20 Aug 2020
- Study start8 Feb 2022
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Epithelial NeoplasmsStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rom Leidner, MD, Principal investigator, Providence Health & ServicesEric Tran, PhD, Principal investigator, Providence Health & Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04520711
- Sponsor's protocol ID
- 2020000584
- Status last verified
- Apr 2026
- First submitted
- 15 Aug 2020
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hotspot TCR-T: A Phase I/Ib Study of Adoptively Transferred T-cell Receptor Gene-engineered T Cells (TCR-T) Targeting Tumor-Specific Neoantigens, With in Vivo CD40 Activation and PD-1 Blockade, for Patients With Incurable Cancers (2020000584)
- ClinicalTrials.gov ID
- NCT04520711
- Acronym / sponsor ID
- 2020000584
- Conditions
- Malignant Epithelial Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 20 Aug 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.
This is a phase I/Ib study of adoptively transferred T-cell receptor gene-engineered T cells (TCR-T) targeting tumor-specific antigens, with in vivo CD40 activation and PD-1 blockade, for patients with incurable cancers. The study design is a safety lead-in TCR-T with CD40/PD-1 (3+3), followed by Simon's Two-Stage expansion design, 80% power and 5% one-sided alpha: stage-one futility assessment at n = 10; stage-two assessment at n = 22, (accrual up to 24 to allow for potential study drop-out).
Detailed description
Patients will be infused with T cells engineered to express TCRs targeting one to five tumor-specific antigens expressed by their autologous tumor. The number of T cells infused will range from 1e9 to 1e11. Monoclonal antibodies targeting PD-1 (pembrolizumab) and CD40 (CDX-1140, Celldex Therapeutics)43 will be administered, in that order, starting within 24 hours of cell infusion and re-administered at approximately 3 week intervals. Clinic visits will include longitudinal evaluation of toxicities and monitoring of immunological parameters. The presence or absence of replication competent retrovirus (RCR) will be evaluated for the first year following adoptive cell transfer, or longer, if there is evidence of RCR.
Tumor Response assessment by RECIST 1.1 is performed every 9-12 weeks. Study treatment continues until progression. Option repeat TCR-T infusion is allowed and in addition may incorporate preconditioning chemotherapy using a de-intensified non-myeloablative (NMA) regimen consisting of a single dose of gemcitabine and a single dose of either cyclophosphamide or epirubicin, designed to elicit immunogenic cell death and transient lymphopenia.
The primary objective of this study is to determine the safety of the adoptive transfer of TCR-gene engineered T cells targeting TSA in combination with CD40 and PD-1 immunotherapy. The secondary objective is to determine whether this therapy can mediate objective clinical responses as determined by objective criteria (e.g. RECIST 1.1). The study will also characterize the differentiation and functional state of the TCR-gene modified T cells before and after cell therapy and monitor their persistence in the patient after treatment. Up to 24 patients will be enrolled in this study. Based on published trials treating patients with TCR-transduced T cells, adverse events such as fever, chills, dyspnea, hypotension, fatigue, edema, rash, and rarely acute cytokine release syndrome, may occur.
Clinical and immunological data will be analyzed which will determine whether this therapy is safe and effective, and whether there are biomarkers or immunological signatures that correlate to efficacy and/or lack of efficacy. This data will determine whether additional studies are warranted.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CDX-1140 + TCR-T + Pembro | Experimental | Biological: TCR-transduced T cells, Drug: CDX-1140, Drug: PembrolizumabPatients will receive CDX-1440, TCR-T, and pembrolizumab. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- Patients 18 years and older with metastatic or locoregionally advanced epithelial cancers, that are considered incurable.
- Confirmation by Tran Laboratory of neoantigen-reactive TCR(s) suitable for TCR-gene therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
- Laboratory values:
- Patients positive for hepatitis B core antibody (anti-HBc, total), are eligible only if HBV DNA is non- detectable by qPCR.
Key exclusion criteria (29 listed)
- Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
- Receipt of any investigational anticancer therapy during the last 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study treatment. Receipt of any prior anti-CD40 therapy.
- Any concurrent chemotherapy, biologic, or hormonal therapy for cancer treatment, within 21 days (6 weeks for nitrosoureas) or at least 5 half-lives (whichever is longer) prior to the first dose of study treatment. Concurrent use of 4. hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
- 5. Local treatment of isolated lesions for palliative intent is acceptable (e.g., local surgery or radiotherapy), excluding target lesions, Palliative radiation therapy cannot be administered less than 1 week prior to the first dose of study treatment.
- 6. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug. Participants must have recovered (to a grade 1 or lower) from all radiation-related toxicities, not require corticosteroids for this purpose and not have had radiation pneumonitis.
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 |
|---|---|---|
| TCR-transduced T cellsTSA-reactive TCR-engineered T cells | Biological | CDX-1140 + TCR-T + Pembro |
| CDX-1140Recombinant fully human IgG2κ monoclonal antibody | Drug | CDX-1140 + TCR-T + Pembro |
| PembrolizumabHumanized immunoglobulin G4 (IgG4) monoclonal antibody | Drug | CDX-1140 + TCR-T + Pembro |
Primary outcome
Evaluate the safety, tolerability and DLTs of combinatorial adoptively transferred T-cell receptor gene-engineered T cells (TCR-T) with in vivo CD40 activation and PD-1 blockade, for patients with incurable cancers
Time frame: 2 years
Analysis of adverse events
4 secondary outcomes
Objective response rate
Time frame: 2 years
Duration of response
Time frame: 2 years
Clinical benefit rate
Time frame: 2 years
Overall survival
Time frame: 2 years
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 13 Apr 2026.
- 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.
Rom Leidner, MD principal investigator
Providence Health & Services
Eric Tran, PhD principal investigator
Providence Health & Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TCR-transduced T cells, CDX-1140 and Pembrolizumab in people with Malignant Epithelial Neoplasms, run by Providence Health & Services at 1 site 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 19 inclusion and 29 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Evaluate the safety, tolerability and DLTs of combinatorial adoptively transferred T-cell receptor gene-engineered T cells (TCR-T) with in vivo CD40 activation and PD-1 blockade, for patients with incurable cancers (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 13 Apr 2026.