Your session is about to expire
← Back to Search
CAR T-cell Therapy
TNB-383B for Multiple Myeloma
Phase 1 & 2
Waitlist Available
Research Sponsored by Teneobio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has confirmed evidence of relapse/progression from the immediately prior MM therapy, or participant is relapsed/refractory to the immediately prior MM therapy.
Must have an estimated glomerular filtration rate >= 30 mL/min as estimated by the Modification of Diet in Renal Disease formula.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is studying a new drug for people with relapsed or refractory multiple myeloma who have had 3 or more lines of prior therapy. The study will look at the safety, how the body processes the drug, and how well the drug works. The study has 4 parts, and will enroll up to 170 participants total.
Who is the study for?
This trial is for people with Multiple Myeloma who've tried at least three previous treatments, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody. They need to have certain levels of M-protein or free light chains in their blood and good kidney function. People can't join if they've had other cancers (with some exceptions), major heart issues, severe nerve damage, recent cancer treatment or surgery, or active infections.Check my eligibility
What is being tested?
TNB-383B is being tested on patients with relapsed/refractory Multiple Myeloma. The study has four parts: testing different doses every three weeks (Arm A), expanding the dose group once the best dose is found (Arm B), and then further testing this dose every four weeks (Arm E) and every three weeks (Arm F).See study design
What are the potential side effects?
As TNB-383B is still in early testing phases, specific side effects are not fully known but may include typical reactions related to immune system activation such as fever, fatigue, infusion-related reactions and potential impact on normal blood cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My multiple myeloma has worsened or not responded to my last treatment.
Select...
My kidney function is good enough, based on a specific test.
Select...
I've had 3+ treatments including PI, IMiD, and anti-CD38.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUClast)
Clearance (CL) of TNB-383B
Maximum Observed Plasma Concentration of TNB-383B (Cmax)
+6 moreSecondary outcome measures
Duration of Objective Response (DOR)
Objective Response Rate (ORR)
Percentage of Participants with Overall Survival (OS)
+3 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: Arm F: Monotherapy Dose CExperimental Treatment1 Intervention
An expansion cohort will be enrolled at the recommended phase 2 Dose C.
Group II: Arm E: Monotherapy Once Every 4 Weeks (Q4W)Experimental Treatment1 Intervention
An expansion cohort will be enrolled at the recommended phase 2 Dose A.
Group III: Arm B: Dose Expansion Dose BExperimental Treatment1 Intervention
An expansion cohort will be enrolled at the recommended phase 2 Dose B.
Group IV: Arm B: Dose Expansion Dose AExperimental Treatment1 Intervention
An expansion cohort will be enrolled at the recommended phase 2 Dose A.
Group V: Arm A: Dose EscalationExperimental Treatment1 Intervention
Up to 15 cohorts of participants receiving sequentially ascending doses of TNB-383B are planned until maximum tolerated dose is reached or recommended phase 2 dose is identified.
Find a Location
Who is running the clinical trial?
Teneobio, Inc.Lead Sponsor
3 Previous Clinical Trials
216 Total Patients Enrolled
1 Trials studying Multiple Myeloma
AbbVieIndustry Sponsor
954 Previous Clinical Trials
500,824 Total Patients Enrolled
34 Trials studying Multiple Myeloma
5,171 Patients Enrolled for Multiple Myeloma
TeneoOne Inc.Lead Sponsor
3 Previous Clinical Trials
390 Total Patients Enrolled
3 Trials studying Multiple Myeloma
390 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a high level of M-protein in your blood.I have a history of specific blood, nerve, organ, hormone, protein, or skin conditions.I have severe nerve damage in my hands or feet.Your blood test shows high levels of a specific protein called free light chain and an abnormal ratio of this protein in your blood.I am currently being treated for a serious infection.My multiple myeloma has worsened or not responded to my last treatment.Your total bilirubin level must be within a certain range, unless you have a condition called Gilbert's syndrome, in which case there's a different range.Your blood calcium level is within the normal range.You have too much M-protein in your urine over a 24-hour period.My kidney function is good enough, based on a specific test.I have received BCMA-targeted therapy before.I haven't had cancer treatment or major surgery in the last 21 days or within 5 half-lives of a cancer drug.My bone marrow is functioning well.You have a disease that can be measured by specific criteria.My myeloma has affected my brain or spinal cord.I haven't had cancer, except for certain skin cancers or low-risk prostate cancer, in the last 3 years.I had a stem cell transplant recently.I have a history of serious heart problems.I've had 3+ treatments including PI, IMiD, and anti-CD38.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B: Dose Expansion Dose B
- Group 2: Arm F: Monotherapy Dose C
- Group 3: Arm A: Dose Escalation
- Group 4: Arm B: Dose Expansion Dose A
- Group 5: Arm E: Monotherapy Once Every 4 Weeks (Q4W)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What primary goals does this medical research endeavor aim to achieve?
"This 12 week clinical trial will evaluate the number of subjects with dose-limiting toxicities (DLT) as its main endpoint. The secondary endpoints are the incidence of Anti-drug Antibody (ADA),Anti-Myeloma Activity by Objective Response Rate (ORR), and Clinical Benefit Rate (CBR). ORR is defined as a confirmed partial or complete response to treatment, while CBR combines CR, PR,and MR results."
Answered by AI
Are there still vacancies in the clinical trial for individuals?
"Yes, based on the information hosted by clinicaltrials.gov this study is actively recruiting participants. This research was first made available to potential volunteers on June 24th 2019 and has been recently updated as of August 22nd 2022."
Answered by AI
What is the current quota for participants in this experiment?
"In order to execute this trial, the sponsor TeneoOne Inc. is needing 214 qualified individuals. Two sites are currently operating in Orlando, Florida (AdventHealth Cancer Institute - Orlando /ID# 242315) and Louisville Kentucky (Norton Cancer Institute - St Matthews /ID# 242368)."
Answered by AI
Which locations can participants access this research?
"The research team is enrolling patients from the AdventHealth Cancer Institute - Orlando /ID# 242315 in Orlando, Florida, Norton Cancer Institute - St Matthews /ID# 242368 in Louisville, Kentucky and Mayo Clinic - Rochester /ID# 238683 in Rochester, Minnesota as well as 21 other locations."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger