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Non-hodgkin Lymphoma,B CellPhase 2NCT03488251

PK,PD,Safety and Tolerability of Multiple Dose Regimens of MT-3724 With Gemcitabine and Oxaliplatin for the Treatment of Patients With Relapsed/Refractory Diffuse Large B Cell Non-Hodgkin's Lymphoma

A Phase 2 study testing MT-3724, Gemcitabine and Oxaliplatin in people with Non-hodgkin Lymphoma,B Cell and Refractory Diffuse Large B-Cell Lymphoma, run by Molecular Templates, Inc. at 9 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and tolerability of MT-3724 in combination with gemcitabine and oxaliplatin (GEMOX) in participants with relapsed or refractory B-Cell NHL. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MT-3724, Gemcitabine and Oxaliplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
9 sitesUnited States
Study dates
20 Aug 2018to 12 Mar 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Be adequately informed about the study and fully consent to participation as demonstrated by signing the written informed consent form before any screening procedure.
  • Be aged ≥18 years on the date of signing the informed consent form.
  • Have relapsed or refractory B-cell NHL that, in the investigator's opinion, could benefit from MT-3724+GEMOX therapy. At least one histologically documented relapse of NHL, by:
  • Bone marrow biopsy (FNA is not acceptable) or
  • Excisional lymph node biopsy or
  • Core biopsy of any involved organ (FNA not acceptable)
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  • CD20-positive histology must have been confirmed at any time during NHL disease course and documented in the medical history
  • If no histology is available after any relapse the investigator can consult the medical monitor to discuss if the patient can be included
  • All subtypes of B-cell NHL may be considered for Part 1 (MT-3724 dose escalation). Only histologically documented DLBCL (including mixed histology) may be considered for Part 2 (expansion cohort).
  • Have received all approved therapies for NHL that are applicable for the patient in the opinion of the treating physician.
  • Patients refractory to treatment are eligible.
  • Patient who have progressed following CAR T-cell therapy are also eligible.
  • Have measurable disease by Lugano Classification for NHL
  • >1.5 cm longest diameter (LDi) for lymph nodes
  • >1 cm LDi for extranodal disease
  • Have ECOG performance score of ≤2.
  • Have adequate bone marrow function, as determined by:
  • Absolute neutrophil count (ANC) ≥1,000/mm3 and
  • Platelet count ≥50,000 mm³
  • Have adequate kidney function, assessed by thecreatinine clearance (CLcr) to be ≥ 50 mL/min either measured or estimated using the Cockcroft-Gault formula. .
  • At the investigator's discretion,calculated estimated CLcr of < 50mL/min may be verified eGFR based on the 24-hour urine collection. Subjects with GFR ≥50 mL/min will be eligible irrespective of the estimated CLcr result.
  • Have adequate hepatic function, as determined by:
  • Total bilirubin ≤1.5 x ULN, or ≤3 x ULN for subjects with Gilbert's Syndrome and
  • Aspartate aminotransferase (AST) ≤3 x ULN (or ≤ 5.0 x ULN if liver involvement) and
  • Alanine aminotransferase (ALT) ≤3 x ULN (or ≤ 5.0 x ULN if liver involvement).
  • Have adequate coagulation, as determined by:
  • INR or PT ≤1.5 x ULN
  • aPTT ≤1.5 x ULN
  • Have adequate serum albumin, as determined by:
  • Albumin ≥ 3.0 g/dL
  • Women of reproductive potential must have a negative pregnancy test during the screening period within 72 hours before the start of treatment. Women not of reproductive potential are female subjects who are postmenopausal or permanently sterilized (e.g., tubal occlusion, hysterectomy,bilateral salpingectomy).
  • Subjects of reproductive potential and their partners must agree to either to abstain continuously from heterosexual intercourse or to use a reliable birth control method between signing the informed consent until 6 months following the last dose of MT-3724 or GEMOX . The investigator or a designated associate should advise the subject how to achieve adequate contraception. The following birth control methods may be considered as adequate
  • Condoms (male or female) with or without a spermicidal agent;
  • Diaphragm or cervical cap with spermicide;
  • Intrauterine device;
  • Hormone-based contraception: Established use of oral, injected, or implanted hormonal methods of contraception;
  • True abstinence;
  • Vasectomy is an acceptable method for a male subject or male partner of a female subject.

Who cannot join

  • History or current evidence of neoplastic disease that is histologically distinct from NHL except cervical carcinoma in situ, superficial noninvasive bladder tumors, curatively treated Stage I-II non-melanoma skin cancer, or any other previous cancer curatively treated >2 years before the start of treatment.
  • Current evidence of new or growing brain or spinal metastases during screening.
  • History of allogeneic hematopoietic stem cell transplant within 180 days before the start of treatment.
  • Current evidence of acute or chronic Graft versus Host Disease.
  • Current evidence of CTCAE Grade >1 toxicity (except for hair loss, and those toxicities
  • Current evidence of incomplete recovery from surgery before the start of treatment, or planned surgery at any time during the study until the EoT Visit, except minor elective interventions deemed acceptable by the investigator.
Show all 23Show fewer
  • History or current evidence of significant (CTCAE Grade ≥2) infection or wound within 4 weeks before the start of treatment.
  • Patients with uncontrolled or severe cardiovascular disease, including myocardial infarct or unstable angina within 6 months prior to start of study treatment, New York Heart Association (NYHA) Class II or greater congestive heart failure, serious arrhythmias requiring medication for treatment, clinically significant pericardial disease, or cardiac amyloidosis may not be enrolled.
  • Patients with a known history of drug abuse or any chronic neurologic, psychiatric, endocrine, metabolic, immunologic, hepatic or renal disease (including a history of hemolytic uremic syndrome) that in the opinion of the Investigator would adversely affect study participation.
  • Patients with known active Hepatitis C, HIV or a present history of Hepatitis B
  • Women who are pregnant or breastfeeding
  • History or current evidence of hypersensitivity to any study drugs, or current evidence of hypersensitivity requiring systemic steroid doses ≥20 mg/day Prednisone equivalent
  • Received any amount of anti-CD20 MAb therapy within the following periods before the start of treatment
  • Rituximab (Rituxan®): 84 days; if a subject had received rituximab within 37 Weeks before the start of treatment, then a serum rituximab level must be negative (<500 ng/mL) at the screening period
  • Obinutuzumab (Gazyva®): 184 days
  • Ofatumumab (Arzerra®): 88 days
  • Received therapy for NHL (except anti-CD20 Mab listed above) within 4 weeks before the start of treatment
  • Any investigational drug treatment from 4 weeks or 5 half-lives of the agent before the start of treatment, whichever is longer, until the EoT Visit
  • Received radiotherapy to tumor lesions that would be chosen as target lesions (measurable disease) within 4 weeks before the start of treatment, unless the lesion exhibited objective progression between the radiotherapy and the screening according to the Lugano Classification for NHL.
  • Palliative radiotherapy to non-target lesions is allowed at the investigator's discretion after consultation with the Medical Monitor and sponsor.
  • Received any vaccines within 28 days of the start of treatment, or likely to require vaccines at any time from the start of treatment until 28 days after the last dose of MT-3724. Injectable flu vaccine (inactivated or recombinant) is permitted at the investigator's discretion
  • Received systemic immune modulators within 2 weeks before the start of treatment including but not limited to systemic corticosteroids >20 mg/day of prednisone equivalent, cyclosporine and tacrolimus. Corticosteroids for pre-medication and NSAIDs are permitted.
  • Received any investigational drug treatment within 4 weeks or within 5 half-lives of the therapeutic agent before the start of treatment, whichever is longer, until EoT Visit

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • University of Maryland Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201

  • Rush University

    Chicago, Illinois, 60612

  • Good Samaritan Hospital

    Cincinnati, Ohio, 45220

  • UT Southwestern Medical Center Clinical Research

    Dallas, Texas, 75390

  • Duke Cancer Center

    Durham, North Carolina, 27710

  • Indiana Blood and Marrow Transplantation

    Indianapolis, Indiana, 46237

  • UC Irvine Health / Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • Sarcoma Oncology

    Santa Monica, California, 90403

  • Innovative Clinical Research Institute

    Whittier, California, 90603

Other trials in United States

About this study

Official title: Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Dose Regimens of MT-3724 With Gemcitabine and Oxaliplatin for the Treatment of Subjects With Relapsed or Refractory B Cell Non-Hodgkin's Lymphoma

The purpose of this study is to evaluate the safety and tolerability of MT-3724 in combination with gemcitabine and oxaliplatin (GEMOX) in participants with relapsed or refractory B-Cell NHL.

Read the detailed description

This is a multi-center, open-label two-part study evaluating the safety and tolerability of MT-3724 in combination with GEMOX in relapsed or refractory B-cell Lymphoma patients.

Part 1: (MT-3724 Dose Escalation) Define the maximum tolerated dose (MTD) of MT-3724 in combination with standard treatment of GEMOX

Part 2: (MTD Expansion Cohort) Confirm the safety and tolerability of the MTD of MT-3724 from Part 1 in the MTD Expansion Cohort, where MT-3724 will be given at the MTD in combination with GEMOX. In addition, the PK, PD, immunogenicity and tumor response at the MTD of MT-3724 in combination with GEMOX will be more thoroughly evaluated in Part 2.

In original protocol and amendment 2, participants will be administered intravenous (IV) MT-3724 over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants will also be administered Gemcitabine 1000 milligrams per meter square (mg/m^2) as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants will be administered MT-3724 on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 will be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin will be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).

Continued Treatment with MT-3724 in combination with GEMOX will continue for four cycles of until death, disease progression, unacceptable toxicity, withdrawal of consent or another reason for withdrawal.

After four cycles, the participants who experience clinical benefit can continue MT-3724 treatment with additional cycles of 28 days each (either alone or in combination with GEMOX) if supported by the investigator's assessment of the benefit-risk ratio, after consultation with sponsor and Medical Monitor

Being tested
MT-3724, Gemcitabine, Oxaliplatin
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MT-3724Drug

    MT-3724 will be administered.

  • GemcitabineDrug

    Gemcitabine will be administered.

  • OxaliplatinDrug

    Oxaliplatin will be administered.

Study groups in NCT03488251
Study groupRoleWhat they receive
Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OXExperimentalIn original protocol and amendment 2, participants will be administered intravenous (IV) MT-3724 10 micrograms per kilograms (mcg/kg) over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants will also be administered Gemcitabine 1000 milligrams per meter square (mg/m^2) as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants will be administered MT-3724 10 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 10 mcg/kg will be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin will be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).
Receives: Drug: MT-3724; Drug: Gemcitabine; Drug: Oxaliplatin
Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OXExperimentalIn original protocol and amendment 2, participants will be planned to administer IV MT-3724 25 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants will also be planned to administer Gemcitabine 1000 mg/m^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants will be planned to administer MT-3724 25 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 25 mcg/kg will be planned to administer weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin will be planned to administer on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).
Receives: Drug: MT-3724; Drug: Gemcitabine; Drug: Oxaliplatin
Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OXExperimentalIn original protocol and amendment 2, participants will be planned to administer IV MT-3724 50 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants will also be planned to administer Gemcitabine 1000 mg/m^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants will be planned to administer MT-3724 50 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 50 mcg/kg will be planned to administer weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin will be planned to administer on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).
Receives: Drug: MT-3724; Drug: Gemcitabine; Drug: Oxaliplatin
Part 2: MT-3724/ GEM/ OXExperimentalParticipants will be planned to administer Maximum tolerated dose (MTD) of MT-3724 in combination with Gemcitabine and Oxaliplatin (GEMOX).
Receives: Drug: MT-3724; Drug: Gemcitabine; Drug: Oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs)

    A DLT is any treatment-emergent adverse event (TEAE) that occurred after the start of infusion in cycle 1 of Part 1 and the TEAE is at least possibly related to the study drug, as determined by the sponsor after consultation with the investigator(s).

    Measured: Up to 168 Days

  2. Part 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    An AE is as any untoward medical occurrence in a participant or clinical investigation in a participant administered a pharmaceutical product(s) and which does not necessarily have to have a causal relationship with this experimental intervention(s). A SAE is any AE that is fatal or life-threatening, permanently disabling (incapacitating or interfering with the ability to resume usual life patterns), results in unplanned in-subject hospitalization or prolongation of an existing hospitalization, results in a congenital abnormality or birth defect, or any other situation that require medical or scientific judgement. Number of participants with common >=0 percent (%) TEAEs and SAEs are presented.

    Measured: Up to 168 Days

Secondary outcomes (10)

  1. Part 1 and 2: Maximum Concentration (Cmax) Following Administration of MT-3724

    Blood samples were planned to be collected at indicated time points for pharmacokinetic (PK) analysis of MT-3724. PK Population consisted of all participants who received at least one dose of MT-3724 and have at least one post-Baseline PK value.

    Measured: Cycle(C)1:Day1:Predose,10 minutes(min) before end of treatment(EOT),5,30 min,1,2,3,4 hours after EOT,Days5,12:Predose,10 min before EOT,5min,2hours after EOT;C2,C3,C4:Day1:Predose,10min before EOT,5 min after EOT(C1 is 42-days;C2,C3,C4 are 28-days cycles)

  2. Part 1 and 2: Area Under the Plasma Concentration Time Curve (AUC) Following Administration of MT-3724

    Blood samples were planned to be collected at indicated time points for PK analysis of MT-3724.

    Measured: Cycle(C)1:Day1:Predose,10 minutes(min) before end of treatment(EOT),5,30 min,1,2,3,4 hours after EOT,Days5,12:Predose,10 min before EOT,5min,2hours after EOT;C2,C3,C4:Day1:Predose,10min before EOT,5 min after EOT(C1 is 42-days;C2,C3,C4 are 28-days cycles)

  3. Part 1 and 2: Time to Maximum Plasma Concentration (Tmax) Following Administration of MT-3724

    Blood samples were planned to be collected at indicated time points for PK analysis of MT-3724.

    Measured: Cycle(C)1:Day1:Predose,10 minutes(min) before end of treatment(EOT),5,30 min,1,2,3,4 hours after EOT,Days5,12:Predose,10 min before EOT,5min,2hours after EOT;C2,C3,C4:Day1:Predose,10min before EOT,5 min after EOT(C1 is 42-days;C2,C3,C4 are 28-days cycles)

  4. Part 1 and 2: Number of Participants With Immunophenotyping Data Outside the Reference Range

    Blood samples were planned to be collected at indicated time points for analysis of immunophenotyping parameters which included cluster of differentiation (CD)3 (Percentage [%] and absolute), CD4 (% and absolute), CD8 (% and absolute), CD4:CD8 ratio, CD19 (% and absolute), Natural Killer (NK) cells (% and absolute), naïve B cells (% and absolute), non-switched memory B cells (% and absolute), class-switched memory B cells, Immunoglobulin (Ig)M only memory B cells (% and absolute), and total memory B cells (% and absolute).

    Measured: Up to 168 Days

  5. Part 1 and 2: Number of Participants With Anti-drug Antibody Titer

    Blood samples were planned to be collected at indicated time points for analysis of anti-drug antibody titer.

    Measured: Up to 168 Days

  6. Part 1 and 2: Number of Participants With Positive Neutralizing Antibodies

    Blood samples were planned to be collected at indicated time points for analysis of positive neutralizing antibodies.

    Measured: Up to 168 Days

  7. Part 1 and 2: Objective Response Rate

    Objective response rate is defined as the participants with a reduction in tumor size (Partial Response [PR] or Complete Response [CR]) using the Lugano Classification for Lymphoma, adjusted according to Lymphoma response to immunomodulatory therapy criteria (LYRIC).

    Measured: Up to 168 Days

  8. Part 1 and 2: Disease Control Rate

    Disease Control rate is defined as participants with objective response of CR, PR or stable disease (SD) defined as SD for 3 months or longer from the Baseline scan.

    Measured: Up to 168 Days

  9. Part 1 and 2: Duration of Response

    Duration of Response is defined as the time from first documented stable disease to the actual date of disease progression or death, for participants who met the criteria of having stable disease for at least 3 months from Baseline. Data was not collected due to early termination of the trial.

    Measured: Up to 168 Days

  10. Part 1 and 2: Progression-free Survival

    Progression-Free Survival is defined as the time from the start of treatment with MT-3724 on Cycle 1 Day 1 to the date of disease progression or death from any cause. Data was not collected due to early termination of the trial.

    Measured: Up to 168 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2018
  2. Study start20 Aug 2018
  3. Primary completion12 Mar 2021
  4. Study completion12 Mar 2021

Why it stopped: Sponsor decision

Resources

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03488251
Sponsor's protocol ID
MT-3724_NHL_002
Status last verified
Jul 2022
First submitted
12 Mar 2018
Last updated
16 Aug 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MT-3724, Gemcitabine and Oxaliplatin in people with Non-hodgkin Lymphoma,B Cell and Refractory Diffuse Large B-Cell Lymphoma, run by Molecular Templates, Inc. at 9 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 38 inclusion and 23 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: stopped early, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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 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?

Yes. Results are posted in the registry (first posted 16 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Part 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs) (time frame: Up to 168 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03488251.

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 16 Aug 2022.

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