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CAR T-cell Therapy

TAA-Specific Cytotoxic T-Lymphocytes for Multiple Myeloma (TACTAM Trial)

Phase 1
Recruiting
Led By Premal Lulla, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Any patient, ≥ 18 yrs old regardless of sex with a diagnosis of high risk MGUS (defined as have 2 of the following: 1. Non IgG MGUS, 2. M protein ≥ 1.5 g/dl, 3. Abnormal free light chain ratio (<0.26 for lambda restricted disease or >1.65 for kappa restricted disease) or a diagnosis of smoldering myeloma
Any patient, at least 18 yrs old regardless of sex, with a diagnosis of high risk MGUS/smoldering myeloma or patients with a diagnosis of Multiple myeloma after receiving at least one treatment regimen
Must not have
Patients with severe active infection
Patients receiving systemic corticosteroid within 48 hours of CTL infusion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is for patients with Multiple Myeloma, monoclonal gammopathy of undetermined significance (MGUS), or smoldering myeloma (SM). The goal is to find the largest safe dose of TAA-specific CTLs (a new experimental therapy), and to see whether it might help patients by targeting proteins that are expressed by cancer cells.

Who is the study for?
This trial is for adults over 18 with Multiple Myeloma, high-risk MGUS, or smoldering myeloma. Participants must have had at least one prior treatment if they have Multiple Myeloma and should expect to live more than six weeks. They need a certain level of blood oxygen, liver function, and kidney function to join. Pregnant women can't participate; others must use effective birth control.
What is being tested?
The study tests TAA-specific CTLs (immune cells) against five cancer cell proteins in patients with multiple myeloma or related conditions. The goal is to find the highest safe dose of these cells, understand side effects, and see if this therapy helps prevent disease progression.
What are the potential side effects?
While specific side effects are not listed here as it's an investigational product not yet approved by FDA, potential risks may include immune reactions due to infused T-cells targeting normal tissues or complications from underlying health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 or older with high risk MGUS or smoldering myeloma.
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I am 18 or older with high risk MGUS/smoldering myeloma or have multiple myeloma and received treatment.
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I am 18 or older with a high-risk MGUS or smoldering myeloma diagnosis.
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My kidney function, measured by creatinine, is within twice the normal limit for my age.
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My oxygen level is above 93% without extra oxygen, after having radiation therapy.
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My bilirubin and AST levels are within acceptable limits, and my hemoglobin is at least 7.0.
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My white blood cell count is healthy following a transplant.
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I am able to live with some level of independence.
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I haven't taken any standard cancer treatments except for certain medications in the last 48 hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently suffering from a severe infection.
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I have taken corticosteroids within 2 days before receiving a CTL infusion.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Patients with Adverse events
Secondary study objectives
Expansion of the CTLs
Persistence of the CTLs
Reduction of the Multiple Myeloma

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Group CExperimental Treatment1 Intervention
Patients with high risk MGUS or smoldering myeloma receiving a fixed dose TAA-Specific CTLs
Group II: Group BExperimental Treatment1 Intervention
Patients receiving TAA-Specific CTLs as adjunctive therapy following autologous or syngeneic transplant for myeloma
Group III: Group AExperimental Treatment1 Intervention
Patients receiving TAA-specific CTLs as therapy for Myeloma

Find a Location

Who is running the clinical trial?

Harris County Hospital DistrictOTHER_GOV
6 Previous Clinical Trials
375 Total Patients Enrolled
Baylor College of MedicineLead Sponsor
1,028 Previous Clinical Trials
6,030,126 Total Patients Enrolled
6 Trials studying Multiple Myeloma
841 Patients Enrolled for Multiple Myeloma
The Methodist Hospital Research InstituteOTHER
287 Previous Clinical Trials
81,744 Total Patients Enrolled
6 Trials studying Multiple Myeloma
154 Patients Enrolled for Multiple Myeloma
Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
112 Previous Clinical Trials
2,818 Total Patients Enrolled
5 Trials studying Multiple Myeloma
112 Patients Enrolled for Multiple Myeloma
Premal Lulla, MDPrincipal InvestigatorBaylor College of Medicine/Houston Methodist Hospital
4 Previous Clinical Trials
135 Total Patients Enrolled
1 Trials studying Multiple Myeloma
1 Patients Enrolled for Multiple Myeloma

Media Library

TAA-specific CTLs (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02291848 — Phase 1
Multiple Myeloma Research Study Groups: Group A, Group B, Group C
Multiple Myeloma Clinical Trial 2023: TAA-specific CTLs Highlights & Side Effects. Trial Name: NCT02291848 — Phase 1
TAA-specific CTLs (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02291848 — Phase 1
~0 spots leftby Dec 2024
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