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New treatment option for Phase 1
Official title Phase 1 Dose Escalation and Expansion Study of PRAME T Cell Receptor (TCR) Engineered NK Cells in Participants With Recurrent and/or Refractory Melanoma (PRAMETIME-Mel)
ClinicalTrials.gov ID: NCT06660420
What this study is testing
What is Cyclophosphamide?
Cyclophosphamide is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for phase 1.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To find the highest tolerable dose and recommended dose of PRAME-TCR-NK cells that can be given to participants with recurrent and/or refractory melanoma. The safety and tolerability of PRAME-TCR-NK cells will also be studied.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must be 18 years or older.
- Participants must be willing and able to provide informed consent.
- Participants must have HLA A\ 02:01.
- Participants must have histologically documented locally advanced, unrespectable, or metastatic melanoma that is relapsed and/or refractory to immune...
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
You likely can't join if
- Pregnant, breastfeeding, or expecting to conceive within the projected duration of the study, starting with the screening visit through 6 months post...
- Has received systemic anticancer therapy within 2 weeks or 5 half-lives, whichever is shorter, before the start of lymphodepleting chemotherapy. For...
- Participants must have recovered from all AEs due to previous therapies to . Grade 1 or baseline. Participants with Grade 2 neuropathy, alopecia, or...
- Has received prior radiotherapy within 2 weeks of the start of lymphodepleting chemotherapy. Participants must have recovered from all...
- Has received a live vaccine within 6 weeks prior to PRAME-TCR-NK infusion. Examples of live vaccines include but are not limited to, the following...
- Has a diagnosis of immunodeficiency or receiving chronic systemic steroid therapy (in doses exceeding10 mg daily of prednisone equivalent).
See the full eligibility criteria
Who can join
- Participants must be 18 years or older.
- Participants must be willing and able to provide informed consent.
- Participants must have HLA A\ 02:01.
- Participants must have histologically documented locally advanced, unrespectable, or metastatic melanoma that is relapsed and/or refractory to immune checkpoint inhibitor (ICI) therapy including either anti-PD-1 either...
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy 3 months.
- Participants who received one or more prior systemic therapy are allowed for enrollment
- A female participant is eligible to participate if at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidelines in during...
- Male participants must agree to follow the contraceptive guidelines during the study treatment period and for 6 months post PRAME-TCR-NK cell infusion. Male participants who father a child or suspect that they have...
- WOCBP must have a negative urine pregnancy test within 72 hours before the start of lymphodepleting chemotherapy. If a WOCBP has a urine pregnancy test that cannot be confirmed as negative, a serum (beta-human chorionic...
- Participants must have measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST).
- Participants must have adequate organ function as defined below within 10 days before the start of lymphodepleting chemotherapy:
- Left ventricular ejection fraction \>50%.
- Adequate respiratory reserve defined as dyspnea Grade 0 or 1 and baseline oxygen saturation \>92% in room air.
- Willing to undergo mandatory blood collection and biopsies as required by the study.
- Participants must agree not to receive a live vaccine for at least 24 months post-infusion.
- Willing to sign consent for long-term follow-up on protocol PA17-0483 which will be signed at the same time with the clinical trial enrollment consent form.
What rules you out
- Pregnant, breastfeeding, or expecting to conceive within the projected duration of the study, starting with the screening visit through 6 months post PRAME-TCR-NK cell infusion.
- Has received systemic anticancer therapy within 2 weeks or 5 half-lives, whichever is shorter, before the start of lymphodepleting chemotherapy. For participants treated with monoclonal antibodies, at least 3 weeks must...
- Participants must have recovered from all AEs due to previous therapies to . Grade 1 or baseline. Participants with Grade 2 neuropathy, alopecia, or other non-relevant AEs may be deemed eligible at the discretion of the...
- Has received prior radiotherapy within 2 weeks of the start of lymphodepleting chemotherapy. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had...
- Has received a live vaccine within 6 weeks prior to PRAME-TCR-NK infusion. Examples of live vaccines include but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever...
- Has a diagnosis of immunodeficiency or receiving chronic systemic steroid therapy (in doses exceeding10 mg daily of prednisone equivalent).
- History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. The time requirement does not apply to participants who underwent successful...
- Known active CNS metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate if they completed radiation therapy, are clinically stable, and without the requirement of...
- Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine...
- Need for systemic immunosuppressive therapy or other physiological replacement of corticosteroids.
- Interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity.
- Active infection (e.g., COVID-19, influenza, severe acute respiratory syndrome [SARS], recent sepsis). For participants recovered from infections, lymphodepletion may start after full recovery.
- Known human immunodeficiency virus (HIV) infection, active or chronic hepatitis B or hepatitis C virus infection.
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participants participation for the full duration of the study, or is not...
- Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
- Has had an allogeneic tissue/solid organ transplant.
- Clinically significant cardiovascular disease within 12 months before the start of lymphodepleting chemotherapy, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial...
- Prolongation of corrected QT interval using Fridericia's formula to \>480 milliseconds.
- Participants with bleeding or thrombotic disorders or at risk for severe hemorrhage. Participants with a known history of deep vein thrombosis/pulmonary embolism who are on appropriate anti-coagulation treatment are...
- Participants with LDH \> 2.5-fold ULN. The evaluation should be conducted at screening. \-
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.