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New treatment option for Refractory Non-Hodgkin Lymphoma
Official title Study of SIRPant-M in Participants With Relapsed or Refractory Non-Hodgkin's Lymphoma
ClinicalTrials.gov ID: NCT05967416
What this study is testing
What is SIRPant-M?
SIRPant-M is an investigational medicine, given as an once-weekly injectable medicine, being studied as a potential treatment for refractory non-hodgkin lymphoma.
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
- The goal of this study is to test SIRPant-M (RB-1355) , an autologous cell therapy, alone or in combination with focal external-beam radiotherapy in participants with relapsed or refractory non-Hodgkin's lymphoma (NHL). Two dose levels of SIRPant-M are being tested.
- 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
- Adult, defined as age ≥ 18 (at screening), who are willing and able to provide informed consent
- Must have relapsed/refractory lymphoma, received at least 2 lines of systemic therapy, be ineligible or inappropriate for other treatment regimens...
- Histologically or cytologically confirmed diagnosis of NHL, any one of the below:
- Eligible for SIRPant-M monotherapy or SIRPant-M plus focal XRT combination therapy: Diffuse large B-cell lymphoma and cutaneous T-cell lymphoma...
- Eligible for SIRPant-M monotherapy only: Cutaneous B-cell lymphoma, including primary cutaneous follicle center lymphoma and primary cutaneous...
You likely can't join if
- Must not have received prior ITI therapy
- Must not have received ASCT or treatment with cellular therapy including CAR-T within the prior 1 month; must not have received allogeneic stem cell...
- Must not have received prior systemic anti-cancer therapy within the past 14 days before start of study cell therapy
- Must not have received IL-2 therapy within the last 6 months
- Must not have acquired immune defects such as human immunodeficiency virus (HIV)
- Must not have uncontrolled hypertension (systolic \>180 mmHg, diastolic \>100 mmHg)
See the full eligibility criteria
Who can join
- Adult, defined as age ≥ 18 (at screening), who are willing and able to provide informed consent
- Must have relapsed/refractory lymphoma, received at least 2 lines of systemic therapy, be ineligible or inappropriate for other treatment regimens known to have curative potential, and must have recovered from the acute...
- Histologically or cytologically confirmed diagnosis of NHL, any one of the below:
- Eligible for SIRPant-M monotherapy or SIRPant-M plus focal XRT combination therapy: Diffuse large B-cell lymphoma and cutaneous T-cell lymphoma (CTCL), including mycosis fungoides (MF), Sezary Syndrome, anaplastic large...
- Eligible for SIRPant-M monotherapy only: Cutaneous B-cell lymphoma, including primary cutaneous follicle center lymphoma and primary cutaneous marginal zone B-cell, leg type; follicular center lymphoma; chronic...
- Must have at least one accessible lymph node or cutaneous or subcutaneous lesion of 1.5 to 5 cm in one dimension as measured by computed tomography (CT) or positron emission tomography/computed tomography (PET/CT) or...
- Must have a life expectancy \> 3 months; must also be confirmed within 7 days prior to Day 1 of SIRPant-M ITI treatment
- Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2; must also be confirmed within 7 days prior to Day 1 of SIRPant-M ITI treatment
- Must have hematologic values as follows: hemoglobin (Hgb) \> 8 g/dL, ANC \> 500 /mm3, monocyte counts ≥ 200/μL, and platelets \> 50,000/µL; must also be confirmed within 7 days prior to Day 1 of SIRPant-M ITI treatment
- Must have adequate renal and hepatic function as follows:
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<3× the upper limit of normal (ULN) (unless attributed to leukemic involvement or required concomitant medication)
- Calculated creatinine clearance ≥60 milliliter per minute (mL/min) calculated with Cockcroft-Gault formula
- Bilirubin ≤1.5×ULN, unless secondary to Gilbert's Syndrome. Must also be confirmed within 7 days prior to Day 1 of SIRPant-M ITI treatment.
- Cardiac function: Must be American Heart Association (AHA) class 1 without significant limitation of physical activity; must also be confirmed within 7 days prior to Day 1 of SIRPant-M ITI treatment.
- Must not be pregnant or planning to become pregnant. A negative urine or serum pregnancy test result is required for persons of reproductive potential within 72 hours prior to start of study treatment administration.
- All persons of reproductive potential must agree to use an effective contraceptive method during study participation and for a minimum of 90 days after study treatment.
- Biologically female: is premenarcheal, surgically sterile (post hysterectomy, bilateral salpingectomy, or bilateral oophorectomy), postmenopausal (\>12 months of amenorrhea without alternative medical causes), or, if of...
- Biologically male: is vasectomized and has received medical assessment of surgical success, has undergone bilateral orchidectomy, or agrees to use an approved method of contraception (true abstinence of heterosexual...
- In the opinion of the Investigator, must be willing and able to comply with the protocol for the duration of the study including undergoing treatment, the required tumor tissue biopsy procedures, scheduled visits and...
What rules you out
- Must not have received prior ITI therapy
- Must not have received ASCT or treatment with cellular therapy including CAR-T within the prior 1 month; must not have received allogeneic stem cell transplantation within prior 6 months and must have no active...
- Must not have received prior systemic anti-cancer therapy within the past 14 days before start of study cell therapy
- Must not have received IL-2 therapy within the last 6 months
- Must not have acquired immune defects such as human immunodeficiency virus (HIV)
- Must not have uncontrolled hypertension (systolic \>180 mmHg, diastolic \>100 mmHg)
- Must not have diagnosis of unclassifiable B cell lymphoma
- Must not have bleeding diathesis or abnormal values for prothrombin time (PT) or activated partial thromboplastin time (aPTT), international normalized ratio (INR) \> 1.5× ULN
- Must not be receiving anti-platelet drugs that may present a risk for intratumor injections
- Must not have pulmonary disease which, in the opinion of the Investigator, might impair the patient's respiratory tolerance to moderate pulmonary fluid overload (eg, interstitial lung disease, severe chronic obstructive...
- Must not have known alcohol or drug abuse
- Must not have received an investigational agent within the past 30 days before start of study cell therapy
- Must not require a chronic therapy with prednisone at a dose of or exceeding 10 mg/day or equivalent or any other form of immunosuppressive therapy
- Must not have active central nervous system tumors or metastases
- Must not be ineligible to receive 2.5 Gy ×3 focal external-beam radiation therapy as determined by the Radiation Oncologist and Principal Investigator (Cohort 1/Group 2, Cohort 2/Group 4, and Cohort -1/Group 4 only)
- Must not have uncontrolled active viral hepatitis-B, -C, and/or -D infection
- Must not have received a live vaccine within 4 weeks of the baseline/screening visit
- Must not have active, uncontrolled autoimmune disease and/or history of autoimmune diseases at high risk for relapse
- Must not have another malignancy or uncontrolled intercurrent illness, condition, serious medical or psychiatric illness, or circumstance that, in the opinion of the Investigator, could interfere with adherence to the...
- No active systemic infection; must also be confirmed on Day 1 prior to initiation of ITI
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Hackensack, New Jersey, United States
- 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 Duarte, California, United States; Hackensack, New Jersey, United States; 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.