Non-Hodgkin Lymphoma, AdultPhase 1APOLLONCT05798897
Safety and Preliminary Efficacy of MT-601 in Patients With Relapsed/Refractory Lymphoma
A Phase 1 study testing MT-601 in people with Non-Hodgkin Lymphoma, Adult and Non-Hodgkin Lymphoma, Refractory, run by Marker Therapeutics, Inc. at 7 sites in United States.
Trial summary
This study is a Phase 1 multicenter study with a Dose Escalation and Dose Expansion evaluating safety and efficacy of MT-601 administration to patients with Relapsed or Refractory Lymphoma. The starting dose administered is 200 x 10^6 cells (flat dosing). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Non-Hodgkin Lymphoma, Adult, Non-Hodgkin Lymphoma, Refractory, Non-Hodgkin Lymphoma, Relapsed
- What is being tested?
- MT-601
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 7 sitesUnited States
- Study dates
- 2 Jan 2023to 28 Feb 2028
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All applicable inclusion and exclusion criteria must be met at Screening and at Baseline (re-assessment of eligibility within 14 days prior to group assignment).
- Participants are eligible to be included in the study only if all of the following criteria apply and the participant, in the judgement of the Investigator, is an appropriate candidate for experimental therapy:
- General:
- Participant must be ≥ 18 years of age and capable of giving signed informed consent (ICF), which includes compliance with the requirements and restrictions listed in the ICF and in the protocol, at the time of signing the ICF.
- Disease Specific:
- Cytologically or histologically confirmed diagnosis of NHL, HL or CLL based on the 2022 World Health Organization (WHO) criteria for hematolymphoid neoplasms
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- Enrollment of the following subtypes will be eligible:
- LBCL including diffuse large B cell lymphoma, primary mediastinal B cell lymphoma (PMBCL), high grade B cell lymphoma (HGBL), T cell rich B cell lymphoma and transformed indolent lymphoma (transformed iNHL)
- FL
- MCL
- MZL
- HL
- The following additional subtypes may be enrolled in disease specific cohorts during Dose Expansion (upon approval by Sponsor)
- CLL/SLL
- CNS lymphoma
- CAR T cell refractory
- Must have measurable disease as per 2014 Lugano criteria or 2018 iwCLL criteria. Participants with splenic MZL must have measurable splenomegaly on imaging or evidence of bone marrow involvement.
- Prior Treatments
- Participants who are R/R, are intolerant to, or are considered ineligible for systemic standard of care anticancer treatments, including at least 2 prior therapies. Participants who refuse standard of care treatments may also be considered if documentation is provided that he/she has been made aware of all therapeutic options.
- For participants with LBCL, FL, and MCL: Have received CD19-directed CAR T cell therapy and relapsed ≥ 30 days or attained an incomplete response as the best response within 1 year after CAR T cell administration. Participants who refuse or are ineligible for CAR T cell therapy are eligible for this study. Note: during Dose Expansion, a specific cohort may be enrolled to evaluate participants who were refractory to CD19-directed CAR T cell therapy.
- Health Status
- Karnofsky score of ≥70 or performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
- Life expectancy ≥12 weeks
- Adequate blood, liver, renal and cardiac function:
- Hematology: Hemoglobin ≥ 7.0 g/dL (can be transfused), absolute lymphocyte count (ALC) ≥ 300/μL, (prior to apheresis only), absolute neutrophil count (ANC) ≥ 750/μL and platelet count ≥ 50,000/μL (prior to the conditioning regimen only)
- Liver: Bilirubin ≤ 1.5X upper limit of normal (ULN) (exception of bilirubin elevation due to Gilbert's syndrome 3X); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3X ULN
- Renal: Serum creatinine ≤ 1.5X ULN or measured or calculated creatinine clearance ≥ 50 mL/min (prior to the conditioning regimen)
- Cardiac: left ventricular ejection fraction ≥ 45% (prior to the leukapheresis) Sex
- Female: Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective (i.e., with a failure rate of < 1% per year), preferably with low user dependency during the intervention period and for at least 6 months after the last infusion of MT-601 and agrees not to donate eggs (i.e., ova and oocytes) for the purpose of reproduction during this period
- Male participants are eligible to participate if they agree to the following during the intervention period and for at least 6 months after the last infusion of MT-601:
- Refrain from donating sperm
- PLUS either:
- Be abstinent from intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR Must agree to use a male condom AND should also be advised of the benefit for a nonpregnant female partner to use a highly effective method of contraception as a condom may break or leak
Who cannot join
- Patients are excluded from the study if any of the following criteria apply:
- Disease-related
- Evidence of bulky disease at the time of the conditioning regimen (≥ 10 cm in diameter for LBCL or HL and > 6 cm for other subtypes)
- Untreated or ongoing treatment for CNS lymphoma or completed treatment within 2 weeks of apheresis (Note: May be allowed in Dose Expansion if disease specific cohort for CNS lymphoma is opened)
- Refractory to CAR T therapy defined as a best response of stable disease or disease progression (Note: May be allowed in Dose Expansion if disease specific cohort for CAR T cell therapy refractory is opened)
- Requirement for urgent therapy due to tumor mass effects such as bowel obstruction or blood vessel compression Medical Conditions
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- Primary immunodeficiency
- Severe or uncontrolled autoimmune disorder
- History or presence of clinically relevant CNS pathology such as epilepsy, seizure, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
- Unresolved immune effector cell-associated neurotoxicity syndrome (ICANS) from prior CAR T cell administration. Consideration for Grade 1 may be made after discussion with the Medical Monitor
- History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g., cervix, bladder, breast, and/or prostate) unless disease free for at least 3 years
- Cardiac conditions:
- Medically uncontrolled hypertension (≥ 160 mmHg systolic blood pressure or ≥ 100 mmHg diastolic blood pressure)
- Congestive heart failure Class ≥ II as defined by the New York Heart Association
- Acute coronary syndrome (including unstable angina, coronary artery stenting, or angioplasty, bypass grafting within prior 6 months)
- History or evidence of current, uncontrolled, clinically significant, unstable arrhythmias
- Oxygen saturation at room air < 92%
- Participant has known human immunodeficiency virus (HIV) infection, or active hepatitis B virus (HBV)/hepatitis C virus (HCV) infection
- Acute bacterial, viral, fungal infection requiring systemic therapy (uncomplicated urinary tract infection and bacterial pharyngitis are permitted if responding to therapy)
- History of severe allergic reactions to any of the study intervention components including conditioning regimen, dimethyl sulfoxide (DMSO) or to tocilizumab
- Clinically significant reversible toxicities from prior cancer therapy that have not recovered to Grade 1 or baseline
- Participants with Grade 2 neuropathies due to prior treatment will be allowed on study.
- Participants with clinical nonsignificant toxicities, such as alopecia, will be allowed on study.
- Prior/Concomitant Therapy
- Prior to Apheresis:
- Receipt of allogeneic hematopoietic cell transplant (HCT) within 12 months; on immunosuppression or with evidence of donor/mixed chimera
- Receipt of autologous HCT within 3 months
- Treatment with CD19-directed CAR T cell therapy within 3 months
- Treatment with bispecific antibody within 1 month
- Treatment with antibody drug conjugates (ADC's) or PD-1/PD-L1 within 21 days
- Treatment with monoclonal antibodies impacting T cell function within 14 days
- Treatment with systemic immunosuppression including systemic corticosteroids (unless ≤5 mg/day oral prednisone or steroid equivalent) within 14 days
- Treatment with chemotherapy within 7 days
- Prior to the conditioning regimen:
- Treatment with a live, attenuated vaccine within 4 weeks
- Treatment with antibody drug conjugates (ADC's) or PD-1/PD-L1 within 21 days
- Treatment with chemotherapy or biologics/monoclonal antibodies within 14 days
- Treatment with radiation therapy within 7 days
- Treatment with a tyrosine kinase inhibitor (TKI) within 7 days or 5 half-lives (whichever is longer) before conditioning regimen
- Hematopoietic growth factors <2 days
- At either time:
- Treatment with experimental CAR T cell product unless approved by Medical Monitor
- Treatment with other cancer therapy including investigational agents that do not fit in the above categories within 14 days
- Major surgery within 14 days
- Other
- Pregnant or lactating
- Any other issue which, in the opinion of the treating physician, would make the participant ineligible for the study
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
University of Colorado
Aurora, Colorado, 80045
Manali Kamdar, MD, 720-848-0752, manali.kamdar@canschutz.edu
Celeste Canel, 303-724-2692, celeste.canel@canshutz.edu
- Recruiting
Sarah Cannon Research Institute at St. David's South Austin
Austin, Texas, 78704
Aravind Ramakrishnan, MD, 512-816-8600, Aravind.Ramakrishnan@hcahealthcare.com
Eliza Harbert, 512-816-5643, eliza.harbert@sarahcannon.com
- Recruiting
Colorado Blood Cancer Institute (Sarah Cannon)
Denver, Colorado, 80218
Luke Mountjoy, DO, 720-754-4800, Luke.Mountjoy@HealthONECares.com
Mallori Buresh, mallori.buresh@sarahcannon.com
- Recruiting
City of Hope
Duarte, California, 91010
Geoffrey Shouse, DO, PhD, 626-218-2405, gshouse@coh.org
Elizabeth Nguyen, (626) 218-2807, elinguyen@coh.org
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Cari Stockard, 913-588-0512, cstockard@kumc.edu
Haitham Abdelhakim, MD
- Recruiting
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
Mariah Endres, 608-262-7657
Priyanka Pophali, MD
- Recruiting
Cornell
New York, New York, 10065
Nicole Santos, nis7058@med.cornell.edu
Caitlin Gribbin, MD
About this study
Official title: A Phase 1 Study of Patient-Derived Multi-Tumor-Associated Antigen-Specific T Cells (MT-601) Administered to Patients With Relapsed or Refractory Non-Hodgkin and Hodgkin Lymphoma (APOLLO)
This study is a Phase 1 multicenter study with a Dose Escalation and Dose Expansion evaluating safety and efficacy of MT-601 administration to patients with Relapsed or Refractory Lymphoma. The starting dose administered is 200 x 10^6 cells (flat dosing).
Read the detailed description
This study is a Phase 1, multicenter, open-label study designed to evaluate the safety and efficacy of MT-601 in participants with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HL) who either relapsed or had incomplete response after cluster of differentiation (CD) 19-directed chimeric antigen receptor (CAR) T cell therapy or are CAR T cell therapy naïve (ineligible or refused CD19-directed CAR T cell therapy or for whom CAR T cell therapy is not available). The study will consist of two portions or phases: 1) Dose Escalation with allowance for backfilling cohorts (up to 50 participants) followed by 2) Dose Expansion at the preliminary RP2DS in 1-2 disease specific cohorts of up to 29 participants each. The Dose Expansion portion of this study will begin after completion of the Dose Escalation portion. The purpose of the Dose Expansion portion of the study is to evaluate the clinical efficacy of MT-601 at the dose determined to be safe in the Dose Escalation portion.
- Conditions
- Non-Hodgkin Lymphoma, Adult, Non-Hodgkin Lymphoma, Refractory, Non-Hodgkin Lymphoma, Relapsed, Non Hodgkin Lymphoma, Hodgkin Lymphoma, Hodgkin Lymphoma, Adult
- Being tested
- MT-601
- Keywords
- NHL, Lymphoma
- Medical subject headings
- Lymphoma, Non-Hodgkin, Recurrence, Hodgkin Disease, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-601Drug
Multi-antigen specific CD4+ andCD8+ T cells
| Study group | Role | What they receive |
|---|---|---|
| Single Arm Study | Experimental | Single arm study evaluating MT-601 investigational product at 200 million cells and 400 million cells per dose Receives: Drug: MT-601 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation
To assess safety and tolerability of escalating doses of MT-601 by the number of participants with MT-601 Dose Limiting Toxicities (DLTs) and Safety events (including but not limited to): treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), deaths, and clinical laboratory abnormalities per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
Measured: After 3 or 6 patients in each dose cohort have been treated with MT-601 and have had the opportunity to be followed for 28 days.
Dose Expansion (ORR)
To assess anti-tumor activity of MT-601 based on Lugano Classification by the following endpoints:
- Objective response rate (ORR) defined as the proportion of treated patients who achieve a best response of complete remission (CR) or partial response (PR) per Lugano Classification.
- The Clopper-Pearson method will be used to estimate the two-sided exact 95% confidence interval for ORR.
Measured: 12 months after the last patient treated in the Dose Expansion portion of the study receiving the first dose of MT-601.
Dose Expansion (DOR)
To assess anti-tumor activity of MT-601 based on Lugano Classification by the following endpoints:
- Duration of response (DOR) defined for patients who attain a best response of CR or PR and is the time between the date of first documented CR or PR and the date of the first observed progression per Lugano Classification.
- DOR will be estimated using the Kaplan-Meier (KM) product limit method. The median DOR and corresponding 95% confidence intervals (CI) will be estimated.
Measured: 12 months after the last patient treated in the Dose Expansion portion of the study receiving the first dose of MT-601.
Dose Expansion (CR)
To assess anti-tumor activity of MT-601 based on Lugano Classification by the following endpoints:
- Complete remission (CR) rate defined as the proportion of treated patients who achieve a best response of CR per Lugano Classification.
- The Clopper-Pearson method will be used to estimate the two-sided exact 95% confidence interval for CR rate estimates.
Measured: 12 months after the last patient treated in the Dose Expansion portion of the study receiving the first dose of MT-601.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start2 Jan 2023
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin Lymphoma, AdultStudies 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
- 79 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marker Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05798897
- Sponsor's protocol ID
- MRKR-22-601-01
- Acronym
- APOLLO
- Status last verified
- Sep 2026
- First submitted
- 14 Mar 2023
- Last updated
- 15 Sep 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 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Patient-Derived Multi-Tumor-Associated Antigen-Specific T Cells (MT-601) Administered to Patients With Relapsed or Refractory Non-Hodgkin and Hodgkin Lymphoma (APOLLO)
- ClinicalTrials.gov ID
- NCT05798897
- Acronym / sponsor ID
- APOLLO / MRKR-22-601-01
- Conditions
- Non-Hodgkin Lymphoma, Adult, Non-Hodgkin Lymphoma, Refractory, Non-Hodgkin Lymphoma, Relapsed, Non Hodgkin Lymphoma, Hodgkin Lymphoma, Hodgkin Lymphoma, Adult
- Keywords
- NHL, Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 79 participants (estimated)
- Lead sponsor
- Marker Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 5 Apr 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 study is a Phase 1 multicenter study with a Dose Escalation and Dose Expansion evaluating safety and efficacy of MT-601 administration to patients with Relapsed or Refractory Lymphoma. The starting dose administered is 200 x 10^6 cells (flat dosing).
Detailed description
This study is a Phase 1, multicenter, open-label study designed to evaluate the safety and efficacy of MT-601 in participants with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HL) who either relapsed or had incomplete response after cluster of differentiation (CD) 19-directed chimeric antigen receptor (CAR) T cell therapy or are CAR T cell therapy naïve (ineligible or refused CD19-directed CAR T cell therapy or for whom CAR T cell therapy is not available). The study will consist of two portions or phases: 1) Dose Escalation with allowance for backfilling cohorts (up to 50 participants) followed by 2) Dose Expansion at the preliminary RP2DS in 1-2 disease specific cohorts of up to 29 participants each. The Dose Expansion portion of this study will begin after completion of the Dose Escalation portion. The purpose of the Dose Expansion portion of the study is to evaluate the clinical efficacy of MT-601 at the dose determined to be safe in the Dose Escalation portion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm Study | Experimental | Drug: MT-601Single arm study evaluating MT-601 investigational product at 200 million cells and 400 million cells per dose |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- All applicable inclusion and exclusion criteria must be met at Screening and at Baseline (re-assessment of eligibility within 14 days prior to group assignment).
- Participants are eligible to be included in the study only if all of the following criteria apply and the participant, in the judgement of the Investigator, is an appropriate candidate for experimental therapy:
- Participant must be ≥ 18 years of age and capable of giving signed informed consent (ICF), which includes compliance with the requirements and restrictions listed in the ICF and in the protocol, at the time of signing the ICF.
- Cytologically or histologically confirmed diagnosis of NHL, HL or CLL based on the 2022 World Health Organization (WHO) criteria for hematolymphoid neoplasms
- Enrollment of the following subtypes will be eligible:
Key exclusion criteria (47 listed)
- Patients are excluded from the study if any of the following criteria apply:
- Disease-related
- Evidence of bulky disease at the time of the conditioning regimen (≥ 10 cm in diameter for LBCL or HL and > 6 cm for other subtypes)
- Untreated or ongoing treatment for CNS lymphoma or completed treatment within 2 weeks of apheresis (Note: May be allowed in Dose Expansion if disease specific cohort for CNS lymphoma is opened)
- Refractory to CAR T therapy defined as a best response of stable disease or disease progression (Note: May be allowed in Dose Expansion if disease specific cohort for CAR T cell therapy refractory is opened)
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 |
|---|---|---|
| MT-601Multi-antigen specific CD4+ andCD8+ T cells | Drug | Single Arm Study |
Primary outcome
Dose Escalation
Time frame: After 3 or 6 patients in each dose cohort have been treated with MT-601 and have had the opportunity to be followed for 28 days.
To assess safety and tolerability of escalating doses of MT-601 by the number of participants with MT-601 Dose Limiting Toxicities (DLTs) and Safety events (including but not limited to): treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), deaths, and clinical laboratory abnormalities per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
Dose Expansion (ORR)
Time frame: 12 months after the last patient treated in the Dose Expansion portion of the study receiving the first dose of MT-601.
To assess anti-tumor activity of MT-601 based on Lugano Classification by the following endpoints: * Objective response rate (ORR) defined as the proportion of treated patients who achieve a best response of complete remission (CR) or partial response (PR) per Lugano Classification. * The Clopper-Pearson method will be used to estimate the two-sided exact 95% confidence interval for ORR.
Dose Expansion (DOR)
Time frame: 12 months after the last patient treated in the Dose Expansion portion of the study receiving the first dose of MT-601.
To assess anti-tumor activity of MT-601 based on Lugano Classification by the following endpoints: * Duration of response (DOR) defined for patients who attain a best response of CR or PR and is the time between the date of first documented CR or PR and the date of the first observed progression per Lugano Classification. * DOR will be estimated using the Kaplan-Meier (KM) product limit method. The median DOR and corresponding 95% confidence intervals (CI) will be estimated.
Dose Expansion (CR)
Time frame: 12 months after the last patient treated in the Dose Expansion portion of the study receiving the first dose of MT-601.
To assess anti-tumor activity of MT-601 based on Lugano Classification by the following endpoints: * Complete remission (CR) rate defined as the proportion of treated patients who achieve a best response of CR per Lugano Classification. * The Clopper-Pearson method will be used to estimate the two-sided exact 95% confidence interval for CR rate estimates.
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 15 Sep 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.
7 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 MT-601 in people with Non-Hodgkin Lymphoma, Adult and Non-Hodgkin Lymphoma, Refractory, run by Marker Therapeutics, Inc. at 7 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 33 inclusion and 47 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 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 Juan Vera, MD (1 (713) 591-8100, jvera@markertherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Escalation (time frame: After 3 or 6 patients in each dose cohort have been treated with MT-601 and have had the opportunity to be followed for 28 days.). The study lists 4 primary outcomes in all. 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 15 Sep 2026.