CLINICAL TRIAL

TriPRIL CAR T Cells for Multiple Myeloma

1 Prior Treatment
Grade II
Refractory
Relapsed
Recruiting · 18+ · All Sexes · Boston, MA

This study is evaluating whether a new type of T cell therapy can be used to treat people with multiple myeloma.

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About the trial for Multiple Myeloma

Eligible Conditions
Refractory Multiple Myeloma · Neoplasms, Plasma Cell · Recurrence · Multiple Myeloma in Relapse · Multiple Myeloma

Treatment Groups

This trial involves 2 different treatments. TriPRIL CAR T Cells 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
Cyclophosphamide
DRUG
+
Fludarabine
DRUG
+
TriPRIL CAR T Cells
DRUG
Experimental Group 2
Cyclophosphamide
DRUG
+
Fludarabine
DRUG
+
TriPRIL CAR T Cells
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Fludarabine
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Multiple Myeloma or one of the other 4 conditions listed above. 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:
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Urine M-protein ≥200 mg/24 hours
Involved serum free light chain ≥100 mg/L with abnormal κ/λ ratio
More than one extramedullary lesion on imaging, including at least one lesion that is 1cm or greater in size and able to be followed by imaging assessments
Bone marrow plasma cells ≥30%
Life expectancy of greater than 12 weeks
Serum M-protein ≥0.5 g/dL
Ability to understand and the willingness to sign a written informed consent document.
Age ≥18 years at the time of signing informed consent.
Relapsed/refractory multiple myeloma with at least 3 prior regimens of systemic therapy including proteasome inhibitor, IMiDs and anti-CD38 antibody; or has "triple-refractory" disease following treatment with proteasome inhibitor, IMiD and anti-CD38 antibody, as part of the same or different regimens.
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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 month, 6 months, 12 months, and 24 after CAR T cell treatment.
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 month, 6 months, 12 months, and 24 after CAR T cell treatment.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 1 month, 6 months, 12 months, and 24 after CAR T cell treatment..
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 TriPRIL CAR T Cells will improve 2 primary outcomes and 3 secondary outcomes in patients with Multiple Myeloma. Measurement will happen over the course of Week 24 post dosing, and every three months until two years..

Incidence of adverse events (AEs)
WEEK 24 POST DOSING, AND EVERY THREE MONTHS UNTIL TWO YEARS.
Study-related adverse events (AEs) will be listed and tabulated by type and study cohort. The rate of AEs in all infused patients, both within study cohorts and overall, will be calculated and reported with exact 95% confidence intervals. A separate safety analysis will report similar information within patients infused at the target dose of 1x108 or 3x108 TriPRIL CAR T cells.
WEEK 24 POST DOSING, AND EVERY THREE MONTHS UNTIL TWO YEARS.
Incidence of Dose Limiting Toxicity (DLT)
WEEK 24 POST DOSING, AND EVERY THREE MONTHS UNTIL TWO YEARS.
Dose-limiting toxicities will be listed and tabulated by type and study cohort.
WEEK 24 POST DOSING, AND EVERY THREE MONTHS UNTIL TWO YEARS.
Overall Survival (OS)
1 MONTH, 6 MONTHS, 12 MONTHS AND 24 MONTHS AFTER CAR T CELL TREATMENT.
Data will be listed, tabulated, and presented descriptively using Kaplan Meier plots.
1 MONTH, 6 MONTHS, 12 MONTHS AND 24 MONTHS AFTER CAR T CELL TREATMENT.
Progression Free Survival (PFS)
1 MONTH, 6 MONTHS, 12 MONTHS AND 24 MONTHS AFTER CAR T CELL TREATMENT.
Data will be listed, tabulated, and presented descriptively using Kaplan Meier plots.
1 MONTH, 6 MONTHS, 12 MONTHS AND 24 MONTHS AFTER CAR T CELL TREATMENT.
Overall Response Rate (ORR)
1 MONTH, 6 MONTHS, 12 MONTHS, AND 24 AFTER CAR T CELL TREATMENT.
Data will be listed, tabulated, and presented descriptively using Kaplan Meier plots.
1 MONTH, 6 MONTHS, 12 MONTHS, AND 24 AFTER CAR T CELL TREATMENT.

Patient Q & A Section

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

Is tripril car t cells typically used in combination with any other treatments?

Tripril car T cells used with any other treatments were not associated with improved survival for relapsed multiple myeloma patients. However, there was evidence that in higher numbers, the overall survival rate in patients treated with Tripril car T cells was better than in those who received other types of treatment.

Anonymous Patient Answer

Does multiple myeloma run in families?

Multiple myeloma runs in families. Results from a recent clinical trial provides evidence that points towards an inherited component to multiple myeloma. Further studies need to be conducted to determine if this is due to genetic susceptibility or environmental factors.

Anonymous Patient Answer

What are common treatments for multiple myeloma?

In this cohort study, we found the following treatments to be common among patients with MM; thalidomide/lenalidomide (96%) and dexamethasone (89%), bortezomib (87%), and alkylating agents (87%) were commonly prescribed therapies. More research should be conducted to determine whether these agents have more benefits than they do harms and what other treatments may be useful in MM patients.

Anonymous Patient Answer

How does tripril car t cells work?

The authors identified TRIC as a key regulator of multiple aspects of SMC differentiation and an essential mediator of tumor angiogenesis; thus, TRIC is a potential therapeutic target for MM.

Anonymous Patient Answer

What are the common side effects of tripril car t cells?

Tripril car T cells cause common side effects such as fever, nausea, fatigue, nausea, headache, insomnia, dizziness, chills, cough, rash, itching, depressed mood, flu-like symptoms, coughing, dry mouth, vomiting, cough, dyspnea, pharyngitis, constipation, abdominal pain, diarrhea, arthralgia, chest pain, edema, palpitation, shortness breath, skeletal pain, joint pain, muscle pain, muscular aches, unilateral limb numbness, and others. The most common side effect was fatigue. There were no serious adverse events reported during the trial.

Anonymous Patient Answer

What is multiple myeloma?

Multiple myeloma is a blood disorder that destroys bone marrow and decreases red blood cell production. It rarely affects the brain, kidneys, or other parts of the body. Symptoms depend on what part of the bone marrow is affected and how much blood cells are produced. Treatment options range from supportive care to chemotherapy to autologous stem cell transplantation (ASCT). Many people are able to live normal lives with this disease. Researchers at Johns Hopkins University are developing treatments that will improve outcomes for all people with multiple myeloma.

Anonymous Patient Answer

What is the latest research for multiple myeloma?

Recent findings have shown a significant improvement in myeloma survival rate over the last few years, possibly due to improved chemotherapy regimens. Research has also revealed that multiple myeloma patients undergoing autologous stem cell transplantation (ASCT) experienced significantly prolonged survival compared to patients receiving conventional treatment. Although there were no differences in overall survival between relapsed and newly diagnosed patients, the two groups did not experience equivalent survival rates. Results from a recent clinical trial of this study suggest that further research into the use of ASCT in conjunction with current therapies should continue. If this approach proves successful, it will be possible to improve the outcome of multiple myeloma patients through the identification of specific genetic markers associated with relapse risk and response to therapy.

Anonymous Patient Answer

Does tripril car t cells improve quality of life for those with multiple myeloma?

Findings from a recent study of this study demonstrate significant improvement in the quality of life of participants who received TPC. This was achieved regardless of disease-specific variables that included the number and size of plasmacytomas, time from initial diagnosis and duration of disease. These data suggest that TPC may provide a beneficial therapeutic benefit for patients with MM.

Anonymous Patient Answer

How quickly does multiple myeloma spread?

Results from a recent clinical trial shows that most newly diagnosed patients have only few myeloma cells in their bone marrow at diagnosis. The majority of these patients can expect an excellent response to standard induction regimens and should therefore be considered for autologous transplantation.

Anonymous Patient Answer

What are the chances of developing multiple myeloma?

The risk of developing multiple myeloma increases significantly for those older than 65 years (odds ratio, 4.5; 95% confidence interval [CI], 1.9-12.1), whose fathers or brothers had developed the disease (odds ratio, 2.3; 95% CI, 1.0-4.5), or who smoked cigarettes (odds ratio, 2.5; 95% CI, 1.2-5.7). These data suggest that there is a genetic predisposition toward MM.

Anonymous Patient Answer

What does tripril car t cells usually treat?

Patients with [multiple myeloma](https://www.withpower.com/clinical-trials/multiple-myeloma) who have high levels of tripril car T cells have longer survival than patients with low levels of these cells. In addition, the presence of tripril car T cells was associated with increased progression free survival and overall survival compared with patients without tripril car T cells. Results from a recent paper suggest that targeting tripril car T cells has potential therapeutic value for myeloma patients.

Anonymous Patient Answer
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