LymphomaPhase 1/2NCT03983668
CMP-001 for Relapsed and Refractory Lymphoma
A Phase 1/2 study testing CMP-001 and Pembrolizumab in people with Lymphoma, run by Umar Farooq at 1 site in United States.
Trial summary
This study is a single-arm, open-label, phase I/II trial designed to find a CMP-001 dose that, in combination with pembrolizumab, has optimal clinical efficacy and acceptable toxicity for patients with relapsed and refractory lymphomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- CMP-001 and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2020to 8 Apr 2025
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically or cytologically confirmed diagnosis of relapsed or refractory Hodgkin Lymphoma or Non-Hodgkin Lymphoma (B and T cells).
- Male participants: A male participant must agree to use a contraception as detailed in Appendix C of this protocol during the treatment period and for at least five months after the final CMP-001 and pembrolizumab dose and refrain from donating sperm during this period.
- Female participants: A female participant is eligible to participate if she is not pregnant (see Appendix C), not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) as defined in Appendix C OR
- A WOCBP who agrees to follow the contraceptive guidance in Appendix C during the treatment period and for at least 5 months after the last dose of study treatment.
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- The participant (or legally acceptable representative if applicable) provides written informed consent for the trial prior to the initiation of any study procedures. The participant must be capable of understanding and complying with protocol requirements.
- Have measurable disease based on Cheson 2007 (Cheson, et al 2007). Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- Subjects must have at least one tumor lesion with a longest diameter of ≥ 1 cm that can be easily palpated or detected by ultrasound to facilitate intratumoral injection of CMP-001 (eg, tumor in skin, muscle, subcutaneous tissue or accessible lymph node).
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the date of allocation/randomization.
- Patients previously treated with anti B cell directed therapy, such as anti-B cell antibody therapy within the past year or a history of CAR T therapy at any time, will be evaluated for the presence of B cells by flow cytometry on peripheral blood. Patients with > 100 benign B cells will be considered eligible. Those with < 100 benign B cells may still be enrolled at the investigator's discretion but will only proceed to the therapeutic phase of the study if they have been shown to generate an anti-Qbeta antibody response, as demonstrated by ELISA assay, in response to the priming dose of vidutolimod
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to first dose of study drug. (see Appendix C). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137) within 4 weeks of enrollment into this trial.
- Has received prior systemic anti-cancer therapy including investigational agents within 2 weeks or 5 half-lives whichever is shorter, prior to first dose of study drug.
- Note: Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Participants with </= Grade 2 neuropathy may be eligible.
- Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
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- Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (</= 2 weeks of radiotherapy) to non-CNS disease.
- Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks or within 5 half-lives whichever is shorter, prior to the first dose of study treatment.
- Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 2 weeks or within 5 half-lives whichever is shorter, after the last dose of the previous investigational agent.
- Has a diagnosis of primary immunodeficiency disorder or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
- Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
- Has severe hypersensitivity (>/= Grade 3) to pembrolizumab and/or any of its excipients.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has an active infection requiring systemic therapy.
- Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required unless mandated by local health authority.
- Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Patients with allotransplant in past 5 years or those with evidence of graft vs. host disease (GVHD) will be excluded.
- Have inadequate organ function as defined in the following table (Table 3). Specimens must be collected within 10 days prior to the start of study treatment.
- Hematological: Absolute neutrophil count (ANC) ≥1000/µL;Platelets ≥75 000/µL; Hemoglobin ≥8.0 g/dLa;
- Renal: Creatinine OR Measured or calculatedb creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN;
- Hepatic: Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN; AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases);
- Coagulation: International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants;
- ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal.
- a Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks.
- b Creatinine clearance (CrCl) should be calculated per institutional standard. Note: This table includes eligibility-defining laboratory value requirements for treatment; laboratory value requirements should be adapted according to local regulations and guidelines for the administration of specific chemotherapies.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
Official title: Phase I/II Study of Pembrolizumab and In-situ Injection of CMP-001 in Patients With Relapsed and Refractory Lymphomas
This study is a single-arm, open-label, phase I/II trial designed to find a CMP-001 dose that, in combination with pembrolizumab, has optimal clinical efficacy and acceptable toxicity for patients with relapsed and refractory lymphomas.
Read the detailed description
This is a single center, open-label, combined Phase I/II clinical study of intratumoral administration of CMP-001 and intravenous administration of pembrolizumab in selected participants with lymphoma. The key study objective is to find a CMP-001 dose that in combination with pembrolizumab has optimal clinical efficacy and acceptable toxicity. Dose-finding will be performed with an adaptive clinical trial design. Secondary study objectives include characterization of safety, pharmacodynamics, and assessment of anti-lymphoma activity.
- Conditions
- Lymphoma
- Being tested
- CMP-001, Pembrolizumab
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMP-001Drug
Also called CYT003; QbG10; IND # 18627
Immunostimulatory therapeutic agent
PembrolizumabDrug
Also called Keytruda
Humanized antibody used in cancer immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| CMP-001 plus pembrolizumab: Phase I, 5mg dose cohort | Experimental | Intratumoral administration of CMP-001 and intravenous administration of pembrolizumab Receives: Drug: CMP-001; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose Limiting Toxicities Using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v4.0
To examine the toxicity related to the therapy by measuring the number of treatment related adverse events in patients
Measured: From the start of treatment up to two years
Objective Response Rate (ORR)
Objective response rate (ORR) will be assessed by CT or PET-CT scans (with calipers for superficial cutaneous tumors) at Screening and at scheduled follow-up visits. The same imaging modality used at baseline will be used throughout the study when possible. Antitumor activity will be evaluated according to Cheson 2007 criteria.
ORR defined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Progression is defined using RECIST v1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Measured: From the start of treatment up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start31 Jan 2020
- Primary completion23 Aug 2024
- Study completion8 Apr 2025
Why it stopped: Manufacturing issue with investigational drug
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umar Farooq
- Sponsor type
- University, hospital or other
- Collaborators
- Checkmate Pharmaceuticals, Merck Sharp & Dohme LLC, University of Iowa
- Responsible party
- Sponsor-investigator, Umar Farooq, University of Iowa
- Investigators
- Umar Farooq, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03983668
- Sponsor's protocol ID
- 201902747
- Status last verified
- Sep 2025
- First submitted
- 10 Jun 2019
- Last updated
- 30 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thall PF, Cook JD. Dose-finding based on efficacy-toxicity trade-offs. Biometrics. 2004 Sep;60(3):684-93. doi: 10.1111/j.0006-341X.2004.00218.x.
PubMed 15339291Thall PF, Herrick RC, Nguyen HQ, Venier JJ, Norris JC. Effective sample size for computing prior hyperparameters in Bayesian phase I-II dose-finding. Clin Trials. 2014 Dec;11(6):657-66. doi: 10.1177/1740774514547397. Epub 2014 Sep 1.
PubMed 25179541
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Pembrolizumab and In-situ Injection of CMP-001 in Patients With Relapsed and Refractory Lymphomas
- ClinicalTrials.gov ID
- NCT03983668
- Acronym / sponsor ID
- 201902747
- Conditions
- Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Manufacturing issue with investigational drug
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Umar FarooqUniversity, hospital or other
- Collaborators
- Checkmate Pharmaceuticals, Merck Sharp & Dohme LLC, University of Iowa
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 23 Aug 2024 (actual)
- Study completion
- 8 Apr 2025 (actual)
- First posted
- 12 Jun 2019 (actual)
- Results
- Posted 30 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single-arm, open-label, phase I/II trial designed to find a CMP-001 dose that, in combination with pembrolizumab, has optimal clinical efficacy and acceptable toxicity for patients with relapsed and refractory lymphomas.
Detailed description
This is a single center, open-label, combined Phase I/II clinical study of intratumoral administration of CMP-001 and intravenous administration of pembrolizumab in selected participants with lymphoma. The key study objective is to find a CMP-001 dose that in combination with pembrolizumab has optimal clinical efficacy and acceptable toxicity. Dose-finding will be performed with an adaptive clinical trial design. Secondary study objectives include characterization of safety, pharmacodynamics, and assessment of anti-lymphoma activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CMP-001 plus pembrolizumab: Phase I, 5mg dose cohort | Experimental | Drug: CMP-001, Drug: PembrolizumabIntratumoral administration of CMP-001 and intravenous administration of pembrolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically or cytologically confirmed diagnosis of relapsed or refractory Hodgkin Lymphoma or Non-Hodgkin Lymphoma (B and T cells).
- Male participants: A male participant must agree to use a contraception as detailed in Appendix C of this protocol during the treatment period and for at least five months after the final CMP-001 and pembrolizumab dose and refrain from donating sperm during this period.
- Female participants: A female participant is eligible to participate if she is not pregnant (see Appendix C), not breastfeeding, and at least one of the following conditions applies:
- The participant (or legally acceptable representative if applicable) provides written informed consent for the trial prior to the initiation of any study procedures. The participant must be capable of understanding and complying with protocol requirements.
Key exclusion criteria (30 listed)
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to first dose of study drug. (see Appendix C). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137) within 4 weeks of enrollment into this trial.
- Has received prior systemic anti-cancer therapy including investigational agents within 2 weeks or 5 half-lives whichever is shorter, prior to first dose of study drug.
- Note: Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Participants with </= Grade 2 neuropathy may be eligible.
- Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMP-001Also: CYT003; QbG10; IND # 18627Immunostimulatory therapeutic agent | Drug | CMP-001 plus pembrolizumab: Phase I, 5mg dose cohort |
| PembrolizumabAlso: KeytrudaHumanized antibody used in cancer immunotherapy | Drug | CMP-001 plus pembrolizumab: Phase I, 5mg dose cohort |
Primary outcome
Number of Participants With Dose Limiting Toxicities Using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time frame: From the start of treatment up to two years
To examine the toxicity related to the therapy by measuring the number of treatment related adverse events in patients
Objective Response Rate (ORR)
Time frame: From the start of treatment up to two years
Objective response rate (ORR) will be assessed by CT or PET-CT scans (with calipers for superficial cutaneous tumors) at Screening and at scheduled follow-up visits. The same imaging modality used at baseline will be used throughout the study when possible. Antitumor activity will be evaluated according to Cheson 2007 criteria. ORR defined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Progression is defined using RECIST v1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15339291Thall PF, Cook JD. Dose-finding based on efficacy-toxicity trade-offs. Biometrics. 2004 Sep;60(3):684-93. doi: 10.1111/j.0006-341X.2004.00218.x.
- Background: PubMed 25179541Thall PF, Herrick RC, Nguyen HQ, Venier JJ, Norris JC. Effective sample size for computing prior hyperparameters in Bayesian phase I-II dose-finding. Clin Trials. 2014 Dec;11(6):657-66. doi: 10.1177/1740774514547397. Epub 2014 Sep 1.
- 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.
Umar Farooq, MD principal investigator
University of Iowa
1 site 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 CMP-001 and Pembrolizumab in people with Lymphoma, run by Umar Farooq 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 11 inclusion and 30 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 30 Mar 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 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?
Yes. Results are posted in the registry (first posted 30 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Dose Limiting Toxicities Using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v4.0 (time frame: From the start of treatment up to two years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03983668, which also lists 2 linked publications.
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 30 Mar 2026.