CLINICAL TRIAL

TT-01488 for B Cell Malignancies

Waitlist Available · 18+ · All Sexes · Houston, TX

Study to Evaluate the Safety and Tolerability of TT-01488 in Patients With B-Cell Malignancies

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About the trial for B Cell Malignancies

Eligible Conditions
B Cell Malignancies · Neoplasms

Treatment Groups

This trial involves 2 different treatments. TT-01488 is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
TT-01488
DRUG
Experimental Group 2
TT-01488
DRUG

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Men and women ≥ 18 years of age with histologically or cytologically confirmed R/R B-NHL, including but not limited to chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL), Waldenström macroglobulinemia (WM), follicular lymphoma (FL), marginal zone lymphoma (MZL), diffuse large-b-cell lymphomas (DLBCL), and transformed lymphoma who failed or are intolerant to ≥ 1 prior standard of care regimens.
Patients with CLL must have disease requiring treatment as specified in 2018 IWCLL Guidelines (Appendix 5)
Patients with B-cell NHL must have measurable disease per 2014 Lugano Classification (Appendix 6). show original
Body weight ≥ 40 kg
ANC > 750/ul, unless due to bone marrow involvement due to disease. show original
Platelets ≥ 50,000/ul without transfusion within 7 days. show original
You have previously received treatment with BTK inhibitors. show original
You have a minimum IgM level of ≥ 2 times the ULN. show original
You have a performance status of ≤ 2. show original
Hemoglobin ≥ 80 mg/dl without transfusion within 7 days. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 1 - 1.5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 1 - 1.5 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether TT-01488 will improve 3 primary outcomes and 13 secondary outcomes in patients with B Cell Malignancies. Measurement will happen over the course of Up to 28 days after first dose.

Dose-Limiting Toxicity (DLT) of TT-01488
UP TO 28 DAYS AFTER FIRST DOSE
Safety and tolerability of TT-01488 as a single agent
Maximum Tolerated Dose (MTD), if reached, of TT-01488
UP TO 28 DAYS AFTER FIRST DOSE
Safety and tolerability of TT-01488 as a single agent
Objective Response Rate (ORR)
1 - 1.5 YEARS
Preliminary efficacy profile of TT-01488 as a single agent
Half-life (T1/2)
1 - 1.5 YEARS
Pharmacokinetic (PK) profile of TT-01488 as a single agent
Number of participants with treatment-related adverse events (AEs)
1 - 1.5 YEARS
Safety and tolerability of TT-01488 as a single agent. AEs will be assessed per CTCAE v5.0 and may include, but is not limited to, clinically abnormal laboratory tests, physical exams, vital signs, electrocardiograms, and ECOG performance status.
Volume of Distribution (Vd)
1 - 1.5 YEARS
Pharmacokinetic (PK) profile of TT-01488 as a single agent
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is cancer?

Cancer or disease is an umbrella name that describes a change in characteristics over time. It is a process involving the abnormal growth of cells that are able to invade other tissues or organs. Cancer is a disease of cells and the body and has many different kinds. For example, cancers of the skin, lung, prostate, breast, colon, bladder, kidney, brain, or other organs of the body can all be cancer as defined by the World Health Organization. The most common cancers are cervical, nasopharyngeal, prostate, lung, stomach and colon.

Anonymous Patient Answer

How many people get cancer a year in the United States?

With the high (and rising) rates of [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer) and lung cancer and the decline in testis cancer in males over this period, a high number of individuals were diagnosed (nearly 300,000) with some form of cancer. The number of tumors from which a cancer can develop (the “modifiable” number) seems to have increased dramatically (nearly 5-fold) among nonsmoking males and females, respectively, between 1970–1989. The number of Americans diagnosed with cancer seems to be rising.

Anonymous Patient Answer

Can cancer be cured?

We find the answer to be no. There are some possible cures for metastatic [liver cancer](https://www.withpower.com/clinical-trials/liver-cancer). We also find cures in metastatic esophageal cancer that can be performed with limited mortality. But we cannot find cures for other types of cancer.

Anonymous Patient Answer

What causes cancer?

The exact cause of cancer remains unknown, but there is some evidence that some infections and genetic factors increase the chances of developing the disease. The most prominent factors that increase the chances of developing cancer is smoking, excess alcohol consumption, obesity, family history, poor diet and physical inactivity.\n

Anonymous Patient Answer

What are the signs of cancer?

Cancer may manifest in a variety of ways. Painful and swelling joints may be the only first sign. It is therefore important to discuss patients' concerns and symptoms with a GP. Patients may also display signs of malnutrition, such as fatigue, weight loss and anaemia.

Anonymous Patient Answer

What are common treatments for cancer?

The standard treatments for cancer are surgery, radiotherapy, chemotherapy, targeted therapies, and palliative care. The role of alternative medicine, including dietary, herbal, and dietary supplements, is often underrecognized and debated.

Anonymous Patient Answer

What are the common side effects of tt-01488?

Tt-01488 shows no significant toxicity to blood cells or to the bone marrow, and tolerability seems higher than expected with this drug. There is no cross reactivity of tt-01488 with human cell substrates, but some immunogenicity. It causes thrombocytopenia with an unknown mechanism (i. e.

Anonymous Patient Answer

Is tt-01488 typically used in combination with any other treatments?

There was no evidence that the addition of tt-01488 to the standard of care treatments of metastatic renal cell carcinoma led to improved outcomes. Tt-01488 is, however, one of the few that appears to have therapeutic activity in an mRCC model, although further randomized phase III studies are needed to validate this effect. The antitumour action of tt-01488, and its ability to augment the activity of other standard-of-care treatments, warrants further investigation.

Anonymous Patient Answer

What is the average age someone gets cancer?

A baby born in 1990 was approximately 12 years old at the age of cancer appeared for the first time. The same happened with lung cancer. This shows that cancer does not appear at the same age in different parts of the world, but instead there is a global increase in age at cancer onset. [http://www.bmj.sk.nl/content/early/2014/05/03/bmj-vol-35-no-6.3.pdf?sid=17574476-24#.

Anonymous Patient Answer

Have there been any new discoveries for treating cancer?

No new drug is likely to make the practice of oncology less efficient. However, we are still in the early days of the study of the causes and mechanisms of most malignancies. In the new millennium that could change radically. It is more likely that we will utilize the most advanced therapies that will be perfected in the near future. What are the advantages of modern therapy over the old treatments? answer: Advances in cancer therapy have dramatically reduced the mortality rates of many solid tumor malignancies. In general, those that are curable are more successfully treated than those that are not curable.

Anonymous Patient Answer

Does tt-01488 improve quality of life for those with cancer?

Tt-01946 showed no superiority to comparator groups, and did not demonstrate superiority to placebo in these trials. The most meaningful change from baseline was seen in the QoL assessments. The change in the QoL of patients treated with Tt-01946 was not significant enough to conclude a meaningful difference in clinical benefit. While Tt-01946 has shown an impact on the patients' perceptions of pain and satisfaction, the effect is small and insufficient to justify its use in clinical practice. Clinical Trial Number: NCT00975307.

Anonymous Patient Answer

How does tt-01488 work?

We found that TT-01488 was an effective drug candidate to treat TNBC cell lines (SKBR-3 and XRCC1-/-) and in vivo xenograft models when delivered into tumors by the intratumoral injection. TTP-01488 deserves further preclinical study as an effective treatment for TNBC patients.

Anonymous Patient Answer
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