PSB202 for MALT Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Memorial Sloan-Kettering Cancer Center, New York, NY
MALT Lymphoma+13 More
PSB202 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

PSB202 in Patients With Previously Treated-, Relapsed-, Indolent B-Cell Malignancies

See full description

Eligible Conditions

  • MALT Lymphoma
  • Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
  • Mantle Cell Lymphoma (MCL)
  • Indolent Lymphoma
  • Marginal Zone Lymphoma (MZL)
  • Refractory B-Cell Lymphoma
  • Waldenstrom Macroglobulinemia
  • Follicular Lymphoma ( FL)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for MALT Lymphoma

Study Objectives

This trial is evaluating whether PSB202 will improve 2 primary outcomes and 4 secondary outcomes in patients with MALT Lymphoma. Measurement will happen over the course of 3 weeks.

2 months
Area under the Plasma Concentration versus Time Curve (AUC)
Change in CD20+ cell counts
Peak Plasma Concentration (Cmax)
3 weeks
Dose Limiting Toxicity (DLT)
Week 27
Adverse Events
Up to 27 weeks
Number of Patients with measurable Anti-Lymphoma Response

Trial Safety

Safety Progress

1 of 3

Other trials for MALT Lymphoma

Trial Design

1 Treatment Group

Single-arm, escalating dose levels
1 of 1
Experimental Treatment

This trial requires 110 total participants across 1 different treatment group

This trial involves a single treatment. PSB202 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Single-arm, escalating dose levels
Drug
3 + 3 Phase 1 dose escalation design; sequential ascending dose levels.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 months for reporting.

Closest Location

Memorial Sloan-Kettering Cancer Center - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 2 prior treatments for MALT Lymphoma or one of the other 13 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Histologically confirmed CD20+ expressing indolent NHL (defined below), CLL or WM, failed or intolerant to standard of care therapies;
Relapsed/refractory following at least 2 prior lines of standard of care treatment. Prior treatments received must be documented on the enrollment request form. For FL, prior treatment must have included at least 1 rituximab containing regimen.
First three dose levels: in the opinion of the investigator, able to tolerate potentially subtherapeutic doses of PSB202 for the duration of a 28-day DLT observation window.
Histologically confirmed CD20+ expression. For CD37+, if unavailable from the chart at screening, CD37+ expression may be documented from a new or archived blood specimen after enrollment.
Relapsed indolent NHL: histologies that may be included are CLL/SLL, MZL, MALT-lymphoma, follicular NHL, MCL or WM failed, relapsed/refractory or intolerant to at least 2 standard of care therapies. (APPENDIX B). For FL, prior treatment must have included rituximab. MCL must have received a prior alkylating agent.
Patients must have documented disease progression after at least two prior standard-of-care regimens.
Patients must have measurable disease.
Signed Informed Consent;
Eastern Cooperative Oncology Group (ECOG) 0-2
Last dose of any anti-CD20 antibody therapy must have been >4 weeks before the first dose of PSB202

Patient Q&A Section

Can follicular lymphoma ( fl) be cured?

"Despite the high-level of response demonstrated by most patients on traditional chemotherapy regimens, fl demonstrates a very significant risk of relapse and disease progression that makes traditional chemotherapy regimens unworkable. As with other types of high-grade B-cell lymphomas, a multicenter clinical trial aimed at improving outcomes for fl patients is needed to help define the appropriate treatment regimen of patients with fl." - Anonymous Online Contributor

Unverified Answer

What causes follicular lymphoma ( fl)?

"This [study illustrates the various genetic alterations that may occur in follicular lymphoma ( fl) and their relation to the development of fl(https://jamanetwork.com/journals/jamadermatology/article/654726)([19]). An important implication of this study is that the different fl(fl) phenotypes do not necessarily represent the same disease(s)." - Anonymous Online Contributor

Unverified Answer

What are the signs of follicular lymphoma ( fl)?

"Many symptoms can be attributable to the underlying disease. In particular, the presence of B cell neoplasms in the bone marrow is often associated with low-grade symptoms such as fatigue, unexplained weight loss, fever, itchiness and night sweats. The presence of high-grade symptoms such as weight loss, swollen lymph nodes or, more rarely, DLBCL-like symptoms such as anemia, thrombocytopenia, and fevers can cause an increased suspicion for a worse prognosis disease such as fl. High-grade symptoms are associated with increased rates of progression, shortening of progression-free survival and overall survival." - Anonymous Online Contributor

Unverified Answer

How many people get follicular lymphoma ( fl) a year in the United States?

"Follicular lymphoma was diagnosed in over 10,000 US adults per year. This accounts for 0.2% of all US diagnoses made in the year 2000. The incidence appears to be increasing steadily over this time period of analysis. No increase in overall mortality was noted, however, possibly because of earlier recognition of the disease, earlier reporting of diagnosis and initiation of treatment by pathologists." - Anonymous Online Contributor

Unverified Answer

What are common treatments for follicular lymphoma ( fl)?

"The preferred initial treatment for advanced-stage follicular lymphoma ( fl) is R-chop plus rituximab, which is followed by R-CHOP as maintenance therapy. Treatment is then dependent on the extent of disease. Treatment with rituximab is also used in the first-line setting in selected patients. Flu-treated patients can be treated with low-dose chemotherapy. When recurrent follicular lymphoma ( fl) occurs, the R-CHOP regimen with rituximab achieves significant and durable remissions that can persist for more than 15 years in most patients. Appropriate follow-up and supportive care measures are also crucial." - Anonymous Online Contributor

Unverified Answer

What is follicular lymphoma ( fl)?

"Follicular lymphoma ( fl) is now the most common form of lymphoma in England, with more than half of all cases diagnosed in men under 50 years. fl is predominantly a disease of older men, with a peak age of incidence at 65 years, typically presents with symptoms of enlargement of the prostate gland and/or difficulty in passing urine. fl can present with a number of lymphocyte-driven subtypes to which the term "fl "refers, but these can also be of nonlymphoid origin. fl is the most common (60%) histological subcategory of the WHO/ENBW classification for lymphoma. fl is relatively radiosensitive, and local treatment with radiotherapy is the standard therapy for many patients." - Anonymous Online Contributor

Unverified Answer

Is psb202 safe for people?

"A review of the published data in relation to intravenous psb202 and follicular lymphoma show that low doses of psb202 are both well tolerated and confer benefits in patients with follicular lymphoma. It is possible that a higher dose will be useful, as we are still considering the optimal dose for use in follicular lymphoma." - Anonymous Online Contributor

Unverified Answer

How serious can follicular lymphoma ( fl) be?

"In general, most patients with fl are able to overcome their disease. However, about half of patients who develop fl die of it or need allogeneic bone marrow transplantation, and 30 to 40 percent suffer other serious consequences of the disease, including kidney or heart failure or severe neurologic symptoms, such as nerve damage or a stroke. Even patients in the best of circumstances can have fl’s relapse. On the other hand, about 10 percent of patients can experience a sustained remission. To find more up-to-date clinical trials using Power, visit http://www.withpower.com/clinical-trials/ fl." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in psb202 for therapeutic use?

"The most important conclusion of this study is that the psb202 gene represents a potent candidate for the development of protein therapeutics for treating MCL and the most promising molecular target for evaluating its impact on B-CLL." - Anonymous Online Contributor

Unverified Answer

What is psb202?

"Data from a recent study presented here clearly show that psb202 shares structural commonalities with psbO (a well-characterized ribosomal protein), and it belongs to the R-plastid gene family in prokaryotes. Interestingly, psb202-like genes can be found in eukaryotes that are unrelated to a conserved ribosomal protein. Therefore, we suggest that this gene probably fulfills multiple roles in prokaryotes and eukaryotes." - Anonymous Online Contributor

Unverified Answer

Is psb202 typically used in combination with any other treatments?

"It appears that a single or a few therapies of some sort are used to treat a large majority of relapsed and/or relapsed/refractory fFL patients. The use of TAC therapy is a common adjuvant therapy when it is used in combination with other standard and novel agents." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets follicular lymphoma ( fl)?

"[The average age is 65 years]\n\n[fl and [follicular lymphoma](https://www.withpower.com/clinical-trials/follicular-lymphoma) (fl) are the two most common forms of non-Hodgkin's lymphoma (NHL)]\n\n- Mayo Clinic homepage\n- NCI homepage"

"Glyptoperigea\n\nGlyptoperigea is a genus of moths in the family Cecidosidae. The genus was erected by Jacob Hübner in 1820." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for MALT Lymphoma by sharing your contact details with the study coordinator.