Lymphoma, T-Cell, PeripheralPhase 1/2IMAGINENCT05138458
A Study of MT-101 in Subjects With CD5+ Relapsed/Refractory TCL
A Phase 1/2 study testing MT-101 and MT-101 + Conditioning (Lymphodepleting) Chemotherapy in people with Lymphoma, T-Cell, Peripheral and Lymphoma, T-Cell, Cutaneous, run by Myeloid Therapeutics at 6 sites in United States.
Trial summary
This is a Phase 1/2 study to test the safety, tolerability, and efficacy of the investigational agent MT-101 in patients with T cell Lymphoma. MT-101 is made with myeloid cells collected from the patient's blood. The myeloid cells are modified and later infused back into their veins. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, T-Cell, Peripheral, Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides
- What is being tested?
- MT-101 and MT-101 + Conditioning (Lymphodepleting) Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 6 sitesUnited States
- Study dates
- 15 Dec 2021to Oct 2025
- Phase
- Phase 1/2
- 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
- Adults age > or equal to18 at the time the Informed Consent is signed
- Refractory or relapsed pathologically confirmed T Cell Lymphoma (TCL): Peripheral T cell Lymphoma not otherwise specified (PTCL-NOS) , Angioimmunoblastic T cell Lymphoma (AITL), ALK-negative anaplastic large cell lymphoma (ALCL), ALK-positive ALCL, or Mycosis Fungoides (MF) stage IIB-IV including large cell transformation
- CD5-expressing tumor by IHC or flow cytometry of tumor biopsy within 3 months of Screening or at Screening
- Eastern Cooperative Oncology Group performance status < 2
- Adequate organ function as defined in the protocol.
Who cannot join
- B1 and B2 disease (as defined in protocol for subjects with MF)
- Known central nervous system involvement by PTCL
- History of allogeneic transplant
- History of intolerance to leukapheresis, plasmapheresis, or blood donation
- Pregnant or nursing women
- Any acute illness including fever (> 100.4°F or > 38°C), except fever related to tumor
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- Active systemic bacterial, fungal, or viral infection
- Active chronic infection
- Other primary malignancies, except adequately treated malignancies or complete remission
- Active autoimmune disease that has required systemic therapy in the last 2 years
- History of hemophagocytic lymphohistiocytosis
- History of severe, immediate hypersensitivity reaction attributed to penicillin
- Any other condition that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the study requirements.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Dana-Farber/Mass General Brigham Cancer Care
Boston, Massachusetts, 02215
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, 22908
Colorado Blood Cancer Institute
Denver, Colorado, 80218
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Phase 1/2, Open-Label, First-in-human, Multiple Ascending Dose Multicenter Study of MT-101 in Subjects With CD5+ Relapsed/Refractory T Cell Lymphoma
This is a Phase 1/2 study to test the safety, tolerability, and efficacy of the investigational agent MT-101 in patients with T cell Lymphoma. MT-101 is made with myeloid cells collected from the patient's blood. The myeloid cells are modified and later infused back into their veins. The modified myeloid cells recognize the tumor cells and are designed to target and kill them.
Read the detailed description
The research study is divided into two parts. The first part will be to determine the safety and tolerability of the study drug product. During this part of the study, there will be 4 groups of study patients. The first group of patients will receive a low dose of cells, the second group will receive the low dose of cells and lymphodepleting chemotherapy to reduce the number of T cells in the blood, the third group will receive a higher dose of cells, and the fourth group will receive the higher dose of cells and lymphodepleting chemotherapy to reduce the number of T cells in the blood. In the second part of the study, cells with or without chemotherapy will be administered based on results of Part 1 and the safety, tolerability, and efficacy of MT-101 will be assessed. All patient groups will receive 6 doses of drug product over 3 weeks.
- Conditions
- Lymphoma, T-Cell, Peripheral, Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Adoptive Cellular Immunotherapy, Cell Therapy
- Being tested
- MT-101, MT-101 + Conditioning (Lymphodepleting) Chemotherapy
- Keywords
- T Cell Lymphoma, PTCL, CTCL, MF, MT-101, CD5 chimeric antigen receptor, Myeloid cells, Monocytes, Chimeric Antigen Receptor, CAR Monocyte Therapy
- Medical subject headings
- Lymphoma, T-Cell, Peripheral, Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Lymphoma, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-101Biological
CD5 ATAK cells
MT-101 + Conditioning (Lymphodepleting) ChemotherapyOther
IV administration of fludarabine and cyclophosphamide
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 and Cohort 3 | Experimental | MT-101 Receives: Biological: MT-101 |
| Cohort 2 and Cohort 4 | Experimental | MT-101 preceded by conditioning (lymphodepleting) chemotherapy Receives: Other: MT-101 + Conditioning (Lymphodepleting) Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of MT-101
Safety and tolerability of the drug will be determined based on observed adverse events (AEs), including all potential dose limiting toxicities.
Measured: 4 weeks
Secondary outcomes (2)
MT-101 cell kinetics in blood
The quantity of MT-101 RNA in the blood.
Measured: 4 weeks
The objective response rate
The ORR is defined as the number (%) of subjects achieving a best overall response of complete response (CR) or partial response (PR)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start15 Dec 2021
- Primary completionNov 2024 (estimated)
- Study completionOct 2025 (estimated)
Why it stopped: Temporary operational pause; no safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, T-Cell, PeripheralStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Multi-ascending dose escalation
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Myeloid Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michele Gerber, MD, MPH, Study director, Myeloid Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138458
- Sponsor's protocol ID
- MTX-TCL-101
- Acronym
- IMAGINE
- Status last verified
- Nov 2023
- First submitted
- 16 Nov 2021
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open-Label, First-in-human, Multiple Ascending Dose Multicenter Study of MT-101 in Subjects With CD5+ Relapsed/Refractory T Cell Lymphoma
- ClinicalTrials.gov ID
- NCT05138458
- Acronym / sponsor ID
- IMAGINE / MTX-TCL-101
- Conditions
- Lymphoma, T-Cell, Peripheral, Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Adoptive Cellular Immunotherapy, Cell Therapy
- Keywords
- T Cell Lymphoma, PTCL, CTCL, MF, MT-101, CD5 chimeric antigen receptor, Myeloid cells, Monocytes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Temporary operational pause; no safety concerns.
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Myeloid TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 1 Dec 2021 (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 1/2 study to test the safety, tolerability, and efficacy of the investigational agent MT-101 in patients with T cell Lymphoma. MT-101 is made with myeloid cells collected from the patient's blood. The myeloid cells are modified and later infused back into their veins. The modified myeloid cells recognize the tumor cells and are designed to target and kill them.
Detailed description
The research study is divided into two parts. The first part will be to determine the safety and tolerability of the study drug product. During this part of the study, there will be 4 groups of study patients. The first group of patients will receive a low dose of cells, the second group will receive the low dose of cells and lymphodepleting chemotherapy to reduce the number of T cells in the blood, the third group will receive a higher dose of cells, and the fourth group will receive the higher dose of cells and lymphodepleting chemotherapy to reduce the number of T cells in the blood. In the second part of the study, cells with or without chemotherapy will be administered based on results of Part 1 and the safety, tolerability, and efficacy of MT-101 will be assessed. All patient groups will receive 6 doses of drug product over 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multi-ascending dose escalation
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 and Cohort 3 | Experimental | Biological: MT-101MT-101 |
| Cohort 2 and Cohort 4 | Experimental | Other: MT-101 + Conditioning (Lymphodepleting) ChemotherapyMT-101 preceded by conditioning (lymphodepleting) chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults age > or equal to18 at the time the Informed Consent is signed
- Refractory or relapsed pathologically confirmed T Cell Lymphoma (TCL): Peripheral T cell Lymphoma not otherwise specified (PTCL-NOS) , Angioimmunoblastic T cell Lymphoma (AITL), ALK-negative anaplastic large cell lymphoma (ALCL), ALK-positive ALCL, or Mycosis Fungoides (MF) stage IIB-IV including large cell transformation
- CD5-expressing tumor by IHC or flow cytometry of tumor biopsy within 3 months of Screening or at Screening
- Eastern Cooperative Oncology Group performance status < 2
- Adequate organ function as defined in the protocol.
Key exclusion criteria (13 listed)
- B1 and B2 disease (as defined in protocol for subjects with MF)
- Known central nervous system involvement by PTCL
- History of allogeneic transplant
- History of intolerance to leukapheresis, plasmapheresis, or blood donation
- Pregnant or nursing women
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-101CD5 ATAK cells | Biological | Cohort 1 and Cohort 3 |
| MT-101 + Conditioning (Lymphodepleting) ChemotherapyIV administration of fludarabine and cyclophosphamide | Other | Cohort 2 and Cohort 4 |
Primary outcome
Safety and Tolerability of MT-101
Time frame: 4 weeks
Safety and tolerability of the drug will be determined based on observed adverse events (AEs), including all potential dose limiting toxicities.
2 secondary outcomes
MT-101 cell kinetics in blood
Time frame: 4 weeks
The objective response rate
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
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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.
Michele Gerber, MD, MPH study director
Myeloid Therapeutics
6 sites 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 MT-101 and MT-101 + Conditioning (Lymphodepleting) Chemotherapy in people with Lymphoma, T-Cell, Peripheral and Lymphoma, T-Cell, Cutaneous, run by Myeloid Therapeutics at 6 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 5 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: paused, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 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?
Results are not available in the source record.
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?
Safety and Tolerability of MT-101 (time frame: 4 weeks). 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 Nov 2023.