CMP-001 for Relapsed and Refractory Lymphoma

NCT03983668 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: 201902747
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (2)

• 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

  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

  From the start of treatment up to two years

Study Arms (1)

CMP-001 plus pembrolizumab: Phase I, 5mg dose cohort

EXPERIMENTAL

Intratumoral administration of CMP-001 and intravenous administration of pembrolizumab

Drug: CMP-001; Drug: Pembrolizumab

Interventions

CMP-001 DRUG

Immunostimulatory therapeutic agent

Also known as: CYT003; QbG10; IND # 18627

CMP-001 plus pembrolizumab: Phase I, 5mg dose cohort

Pembrolizumab DRUG

Humanized antibody used in cancer immunotherapy

Also known as: Keytruda

CMP-001 plus pembrolizumab: Phase I, 5mg dose cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Umar Farooq: lead
• Checkmate Pharmaceuticals: collaborator
• Merck Sharp & Dohme LLC: collaborator
• University of Iowa: collaborator

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (2)

• 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.

  PMID: 15339291 BACKGROUND

• Thall 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.

  PMID: 25179541 BACKGROUND

MeSH Terms

Conditions

Lymphoma

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Limitations and Caveats

Study terminated early, prior to initiation of Phase II portion, due to manufacturing issue related to study drug.

Results Point of Contact

• Title: Umar Farooq, MD
• Organization: University of Iowa

umar-farooq@uiowa.edu

319-384-8044

Study Officials

• Umar Farooq, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: June 12, 2019
• Study Start: January 31, 2020
• Primary Completion: August 23, 2024
• Study Completion: April 8, 2025
• Last Updated: March 30, 2026
• Results First Posted: March 30, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)