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CAR T-cell Therapy
TEG002 for Multiple Myeloma
Phase 1
Waitlist Available
Research Sponsored by Gadeta B.V.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Toxicities from prior/ongoing therapies recovered to ≤ Grade 2 or subject's baseline
Adequate vital organ function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until year 2
Awards & highlights
Study Summary
This trial is testing a new treatment for multiple myeloma that uses the patient's own T cells that have been modified to express a γδTCR. The study will assess the safety and efficacy of this treatment in a small group of patients.
Who is the study for?
This trial is for adults with relapsed or refractory Multiple Myeloma who have a life expectancy of at least 3 months and are in relatively good health (ECOG status 0 or 1). Participants must be able to use contraception and have recovered from previous therapies. Those with amyloidosis, uncontrolled infections, recent other cancers, severe heart/kidney issues, active CNS disease, or certain blood clots can't join.Check my eligibility
What is being tested?
The study tests TEG002 cells in patients whose Multiple Myeloma has returned after treatment. It's an open-label phase I trial that includes cell collection from the patient (leukapheresis), chemotherapy preparation, followed by TEG002 administration. Patients will be monitored for safety and effectiveness for one year post-treatment.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as fever and fatigue; organ inflammation; infusion-related reactions; bone marrow suppression leading to low blood counts; increased risk of infection due to weakened immune defenses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My side effects from previous treatments are mild or gone.
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My vital organs are functioning well.
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I am fully active or can carry out light work.
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My multiple myeloma has returned or is not responding to treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ until year 2
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until year 2
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety determined by incidence of (S)AEs by type and grade, including the occurrence of dose-limiting toxicities (DLTs)
Safety: For the expansion segment: Confirmation of safety determined by the incidence of (S)AEs by type and grade
Secondary outcome measures
Feasibility of TEG002 generation in r/r MM patients as measured by the number of TEG002 products successfully generated in r/r MM patients
TEG002 efficacy by looking at Duration of response
TEG002 efficacy by looking at Objective response rate
+8 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Single Arm, Open labelExperimental Treatment1 Intervention
This is a single arm, open-label, multicenter phase I study with a dose escalation and an expansion segment.
For the Dose escalation segment, 3-9 patients per dose cohort will receive:
Dose level 1: Low
Dose level 2: Medium
Dose level 3: High
For the expansion segment, additional patients may be enrolled until a maximum of 20 patients have received the recommended dose
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Who is running the clinical trial?
Gadeta B.V.Lead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a stem cell transplant from a donor.My bone marrow is working well.I have been diagnosed with amyloidosis.I do not have any infections that are not responding to treatment.My side effects from previous treatments are mild or gone.You are expected to live for at least 3 more months.I am 18 years old or older.My vital organs are functioning well.I rely on dialysis for kidney function.I am fully active or can carry out light work.I have had a blood clot in my lung or deep veins.I have another cancer that has been in remission for over a year or doesn't need treatment beyond regular check-ups.I am willing to use birth control during the study.I have an autoimmune disease that is active or requires medication to suppress my immune system.I have an active brain or spinal cord disease.My multiple myeloma has returned or is not responding to treatment.I haven't had any experimental or systemic therapy in the last 14 days.I have heart problems that affect my daily activities.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm, Open label
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.
Has TEG002 been granted official clearance by the Food and Drug Administration?
"Although there is not much data to back it, TEG002 has been evaluated as relatively safe; the team at Power assigned this drug a score of 1 on their scale of safety."
Answered by AI
Are there opportunities for people to join this investigation?
"Allegedly, per clinicaltrials.gov this investigation is not recruiting at present - it was first published on May 13th 2021 and last updated on September 7th 2022. Fortunately for those seeking to take part in a study, there are currently 807 other trials actively enrolling participants."
Answered by AI
What are the anticipated results of this investigation?
"According to Gadeta B.V., the primary outcome of this trial will be safety, assessed 28 days after infusion. Additionally, secondary outcomes such as efficacy in terms objective response rate and time to response, as well as pharmacokinetic measurements of TEG002 persistence in bone marrow over time will also be monitored during this study."
Answered by AI
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