CART-TnMUC1 for Multiple Myeloma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Sarah Cannon Research Institute, Nashville, TN
Multiple Myeloma+8 More
CART-TnMUC1 - Biological
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether genetically modified white blood cells may help treat cancer.

See full description

Eligible Conditions

  • Multiple Myeloma
  • Pancreatic Adenocarcinoma (Ductal Adenocarcinoma)
  • Breast Cancer (Triple Negative Breast Cancer (TNBC))
  • Non-Small Cell Lung Carcinoma (NSCLC)
  • Ovarian Cancer
  • Fallopian Tubes Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Multiple Myeloma

Study Objectives

This trial is evaluating whether CART-TnMUC1 will improve 2 primary outcomes and 12 secondary outcomes in patients with Multiple Myeloma. Measurement will happen over the course of Up to 2 years.

Up to 15 years
Peripheral expansion and persistence of CART-TnMUC1 cells in solid tumors and multiple myeloma
Up to 2 years
Cohort Expansion: Objective Response in solid tumors
Dose Escalation: Dose Identification of CART-TnMUC1
Feasibility of CART-TnMUC1 in solid tumors and multiple myeloma
Preliminary anti-tumor efficacy of CART as assessed by Clinical Benefit Rate in solid tumors
Preliminary anti-tumor efficacy of CART as assessed by Duration of Response (DOR) in solid tumors and multiple myeloma
Preliminary anti-tumor efficacy of CART as assessed by Minimal Residual Disease (MRD) in multiple myeloma
Preliminary anti-tumor efficacy of CART as assessed by Objective Response Rate (ORR) in solid tumors and multiple myeloma
Preliminary anti-tumor efficacy of CART as assessed by Overall Survival (OS) in solid tumors and multiple myeloma
Preliminary anti-tumor efficacy of CART as assessed by Progression Free Survival (PFS) in solid tumors
Preliminary anti-tumor efficacy of CART as assessed by Time to Progression (TTP) in multiple myeloma
Preliminary anti-tumor efficacy of CART as assessed by Time to Response (TTR) in solid tumors and multiple myeloma
Safety of CART-TnMUC1 in solid tumors and multiple myeloma
Tolerability of CART-TnMUC1 in solid tumors and multiple myeloma

Trial Safety

Safety Progress

1 of 3

Other trials for Multiple Myeloma

Trial Design

2 Treatment Groups

Dose Escalation Arm1: Solid Tumors
1 of 2
Dose Escalation Arm 2: Multiple Myeloma
1 of 2
Experimental Treatment

This trial requires 112 total participants across 2 different treatment groups

This trial involves 2 different treatments. CART-TnMUC1 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.

Dose Escalation Arm1: Solid TumorsIntravenous CART-TnMUC1 cells for patients with TnMUC1+ treatment-resistant ovarian cancer (including cancers of the fallopian tube), pancreatic ductal adenocarcinoma, hormone receptor (HR)-negative and human epidermal growth factor receptor 2 (HER2)-negative (triple negative) breast cancer and non-small cell lung cancer
Dose Escalation Arm 2: Multiple MyelomaIntravenous CART-TnMUC1 cells for patients with TnMUC1+ relapsed/refractory multiple myeloma
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
FDA approved
Cyclophosphamide
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 15 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 15 years for reporting.

Closest Location

Sarah Cannon Research Institute - Nashville, TN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 2 prior treatments for Multiple Myeloma or one of the other 8 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:
Confirmed diagnosis of metastatic treatment-resistant ovarian cancer (including cancers of the fallopian tube), pancreatic adenocarcinoma, hormone receptor (HR)-negative and HER2-negative (triple negative) breast cancer (TNBC) or non-small cell lung cancer (NSCLC), or relapsed/refractory multiple myeloma
Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
Multiple myeloma: relapsed or refractory disease previously treated with or intolerant to at least three different lines of therapy that contained at least one of the following drug classes: proteasome inhibitor, an immune modulatory drug, alkylators, CD38 monoclonal antibody and glucocorticoids. Patients must be at least 90 days since autologous stem cell transplant
NSCLC: i.) Patients without driver mutations must have received standard therapy, including both checkpoint inhibition and platinum-based chemotherapy or be intolerant of these standard therapies ii.) Patients with driver mutations must have received or be intolerant to prior targeted therapy directed at the specific identified mutations in addition to the standard chemotherapy classes
Pancreatic adenocarcinoma: disease progression following at least one standard of care systemic chemotherapy for metastatic or unresectable disease or be intolerant of these standard therapies
TNBC: ER and/or PR < or =10%, HER2 negative and experienced disease progression following at least one prior systemic anti-cancer therapy regimen as part of their treatment for management of metastatic breast cancer or be intolerant to these standard therapies
Ovarian: platinum-resistant (progression of disease by either CA-125, clinical or radiographic assessment within 6 months of last platinum-based chemotherapy ) and must have received at least two prior lines of therapy for metastatic ovarian cancer, including at least one prior line of therapy including a platinum-containing regimen or be intolerant of these standard therapies
Evaluable disease as defined by tumor type
TnMUC1+ disease, determined by centrally tested TnMUC1 expression in a prior or archival tumor biopsy
Toxicities from any previous therapy must have recovered to Grade 1 or baseline

Patient Q&A Section

What are common treatments for multiple myeloma?

"A multidisciplinary approach to multiple myeloma treatment can result in improved patient outcomes and improved quality of life for patients with the disease and their family members." - Anonymous Online Contributor

Unverified Answer

What is multiple myeloma?

"Multiple myeloma can affect any bone or muscle in the body, and can be deadly. The risk of multiple myeloma increases with age, smoking, and family history of multiple myeloma.\n" - Anonymous Online Contributor

Unverified Answer

What causes multiple myeloma?

"A number of inherited, environmental and biological factors may be involved in multiple myeloma. Genetic risk factors include the presence of certain inherited genes and chromosome translocations and deletions ("see" Multiple myeloma in the context of cancer genetics, section Multiple myeloma). The risk of developing multiple myeloma is also increased by exposure to ionizing radiation and certain agents, smoking, occupational exposure to benzene, asbestos and other occupational chemical toxins, and occupational exposures involving exposures to a mixture of carcinogens.\n" - Anonymous Online Contributor

Unverified Answer

What are the signs of multiple myeloma?

"Significant weight loss and pain are common symptoms of MM. In the presence of severe disease, anemia and bone lesions, there is high suspicion for MM rather than other causes of weight loss or pain. Other signs of MM should be considered only after confirmation of clinical suspicion." - Anonymous Online Contributor

Unverified Answer

How many people get multiple myeloma a year in the United States?

"2,700 of the 4,050 patients with multiple myeloma in the United States will develop or will die within five years of diagnosis. The median survival for multiple myeloma in the United States is seven years, and about 60% of patients live for more than five years. Most patients with multiple myeloma develop the disease before age 65, although 4% will develop age 85 or older." - Anonymous Online Contributor

Unverified Answer

Can multiple myeloma be cured?

"At diagnosis, patients with MM had a median lifespan similar to that of the general population. This result has implications for the design of trials that compare high-intensity therapies to treatment with standard-intensity therapy. Nevertheless, patients with MM may benefit from more intense therapy, even in the form of high-dose therapy." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating multiple myeloma?

"There have not been any new discoveries for treating multiple myeloma in the last five years. New research for treating multiple myeloma is usually focused on drug discovery. There are several types of drugs that are tested as treatments for multiple myeloma. These include bortezomib, lenalidomide, thalidomide, and immunomodulatory drugs." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for multiple myeloma?

"In the event of clinical trial enrollment, we believe that patients with myeloma who are eligible to participate in any of the currently available trials should be enrolled if the clinical trial does not involve intensive therapy or a drug that is not already approved. No other subset of patients should be excluded from clinical trials based on previous treatment." - Anonymous Online Contributor

Unverified Answer

How does cart-tnmuc1 work?

"Cart-tnmuc1 was expressed on MM cells and its expression and secretion increased when cells were treated with CCL13, a chemokine important for MM cell survival. CCL13 decreased the viability of MM cells and induced apoptosis through the activation of caspases caspase 3, caspase 7 and caspase 8. These data suggest that cart-tnmuc1 may play a role in MM cell proliferation, survival and development, and the CCL13/cart-tnmuc1 axis may be a potential therapeutic target." - Anonymous Online Contributor

Unverified Answer

Does cart-tnmuc1 improve quality of life for those with multiple myeloma?

"Cart-TM improves physical and mental functioning by increasing functioning levels in MM patients. It will help MM patients return to normal life roles and may improve quality of life by decreasing physical and emotional burden, leading to enhanced QOL in daily medical management." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving cart-tnmuc1?

"The present study did not find a negative impact of carbetacin in patients with advanced MM, but it does show a strong antitumor effect in patients with RRMM. The potential of carbetacin deserves to be further investigated." - Anonymous Online Contributor

Unverified Answer

How serious can multiple myeloma be?

"Survival from MM was consistently worse in our institution than reported in the literature or for most other solid tumors. Patients were typically treated with relatively new agents and were treated after most patients with MM had succumbed to their disease. The reasons for the poor survival are likely multifactorial; patient, tumor, treatment, and institutional factors all contribute." - 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.
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