← Back to Search

CAR T-cell Therapy

Anti-BCMA CAR-T Cells for Multiple Myeloma

Phase 1
Recruiting
Research Sponsored by Thomas Martin, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Adequate organ function, defined as: Hemoglobulin >8 gm/dl (transfusions allowed), Platelets >50,000/microliter (uL) (in the absence of platelet transfusion within 7 days of apheresis, but transfusion permitted prior to lymphodepleting chemotherapy), Absolute neutrophil count (ANC) > 1000/uL in the absence of growth factor support (filgrastim within 7 days or pegfilgrastim within 14 days of apheresis, but growth factor permitted prior to lymphodepleting chemotherapy), Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =< 3 x institutional upper limit of normal (ULN), Total bilirubin =< 1.5 mg/dl x institutional ULN, except with Gilbert's syndrome, Serum creatinine clearance (CrCl) >= 45 mL/min using Cockcroft-Gault formula, Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) >= 40% as assessed by echocardiogram or multiple uptake gated acquisition (MUGA), Women of childbearing potential (defined as all women physiologically capable of becoming pregnant) must have a negative serum or urine pregnancy test AND agree to use highly effective methods of contraception for 1 year after the last dose of anti-BCMA CAR-T cells, Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years
Awards & highlights

Study Summary

This trial is testing a new cancer treatment to see if it's safe for use in people with multiple myeloma.

Who is the study for?
This trial is for adults over 18 with Multiple Myeloma that's come back or hasn't responded to treatment. They must have tried at least three therapies, including proteasome inhibitors, immunomodulatory drugs, and anti-CD38 antibodies. Participants need good organ function and can't be pregnant or breastfeeding. People with active CNS issues, autoimmune diseases needing recent treatment, uncontrolled illnesses, another cancer (except certain skin cancers), or active hepatitis B/C are excluded.Check my eligibility
What is being tested?
The study tests the safety of anti-BCMA CAR-T cell therapy in those with relapsed/refractory Multiple Myeloma. It involves an open-label design where everyone gets the same experimental treatment after pre-treatment with Cyclophosphamide and Fludarabine to prepare their immune system.See study design
What are the potential side effects?
Potential side effects include reactions related to the infusion process, changes in blood counts leading to increased infection risk or bleeding problems, fatigue, fever, and possible effects on normal organ functions due to immune responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am fully active or can carry out light work.
Select...
You must have certain levels of hemoglobin, platelets, and white blood cells, as well as normal liver and kidney function. You must also have a healthy heart and use birth control during and after the study.
Select...
I have MM and it didn't respond to at least 3 treatments including a PI, an IMiD, and anti-CD38 therapy.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate (ORR)
Proportion of participants who experience a dose-limiting toxicity (DLT) (Dose Escalation)
Proportion of participants with treatment-emergent adverse events (AE) (Dose Escalation)
Secondary outcome measures
Duration of response
Overall Survival
Progression-free Survival (PFS)
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Dose Expansion: Maximum Tolerated Dose (MTD)Experimental Treatment3 Interventions
Participants will undergo apheresis with collection of autologous peripheral blood mononuclear cells that will be used to generate CAR-T cells. After successful generation of the anti-BCMA CAR-T cells, and no dose limiting toxicities were reported for the previous dose level, participants will undergo lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed by 2-5 days of rest. A single infusion of anti-BCMA CAR-T cells at the MTD will then be given on Day 1.
Group II: Dose Escalation (600 x 10^6 CAR + T cells/ infusion)Experimental Treatment3 Interventions
Participants will undergo apheresis with collection of autologous peripheral blood mononuclear cells that will be used to generate CAR-T cells. After successful generation of the anti-BCMA CAR-T cells, and no dose limiting toxicities were reported for the previous dose level, participants will undergo lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed by 2-5 days of rest. A single infusion of anti-BCMA CAR-T cells at the next highest dose of 600 x 10^6 flat dose will then be given on Day 1.
Group III: Dose Escalation (450 x 10^6 CAR + T cells/ infusion)Experimental Treatment3 Interventions
Participants will undergo apheresis with collection of autologous peripheral blood mononuclear cells that will be used to generate CAR-T cells. After successful generation of the anti-BCMA CAR-T cells, and no dose limiting toxicities were reported for the previous dose level, participants will undergo lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed by 2-5 days of rest. A single infusion of anti-BCMA CAR-T cells at the next highest dose of 450 x 10^6 flat dose will then be given on Day 1.
Group IV: Dose Escalation (150 x 10^6 CAR + T cells/ infusion)Experimental Treatment3 Interventions
Participants will undergo apheresis with collection of autologous peripheral blood mononuclear cells that will be used to generate CAR-T cells. After successful generation of the anti-BCMA CAR-T cells, participants will undergo lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed by 2-5 days of rest. A single infusion of anti-BCMA CAR-T cells at the starting dose of 150 x 10^6 flat dose will then be given on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Fludarabine
2012
Completed Phase 3
~1100

Find a Location

Who is running the clinical trial?

Thomas Martin, MDLead Sponsor
3 Previous Clinical Trials
121 Total Patients Enrolled
3 Trials studying Multiple Myeloma
121 Patients Enrolled for Multiple Myeloma
University of California, DavisOTHER
911 Previous Clinical Trials
4,709,559 Total Patients Enrolled
3 Trials studying Multiple Myeloma
4,028 Patients Enrolled for Multiple Myeloma
Eugia Pharma Specialities LimitedUNKNOWN

Media Library

Manufactured Anti-BCMA CAR-T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05577000 — Phase 1
Multiple Myeloma Research Study Groups: Dose Escalation (600 x 10^6 CAR + T cells/ infusion), Dose Escalation (150 x 10^6 CAR + T cells/ infusion), Dose Expansion: Maximum Tolerated Dose (MTD), Dose Escalation (450 x 10^6 CAR + T cells/ infusion)
Multiple Myeloma Clinical Trial 2023: Manufactured Anti-BCMA CAR-T cells Highlights & Side Effects. Trial Name: NCT05577000 — Phase 1
Manufactured Anti-BCMA CAR-T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05577000 — Phase 1

Frequently Asked Questions

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

Are there any opportunities for participation in this clinical trial currently?

"The clinical trial in question is no long actively recruiting patients, per the information hosted on clinicaltrials.gov. The study was initially posted on March 1st 2023 and last modified on October 8th 2022; however, there are still a plethora of other trials that require participants at this time - 807 to be exact!"

Answered by AI

Has the FDA approved a methodology of administering 150x10^6 CAR+ T cells in successive dosages?

"Since this is a Phase 1 investigation, the safety of Dose Escalation (150 x 10^6 CAR + T cells/ infusion) was rated as low - scoring a value of 1 on our scale. This reflects the lack of clinical data to corroborate both efficacy and safety."

Answered by AI

Could you elucidate the primary aims of this investigation?

"According to Actavis Inc., the main outcome measured in this trial will be Proportion of participants who experience a dose-limiting toxicity (DLT) across a time span beginning with initial treatment and ending 29 days following CAR-T infusion. Secondary metrics being assessed are Proportion of patients for whom BCMA CAR T-cell therapy is successfully manufactured, Treatment-emergent adverse events as graded by NCI CTCAE Version 5.0, revised cytokine release syndrome grading criteria (for CRS), ASTCT ICANS Consensus Grading for Adults (for neurotoxicity), and Overall Survival which will be calculated through Kaplan Meier"

Answered by AI

Who else is applying?

What site did they apply to?
University of California, San Francisco
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Anti-BCMA Chimeric Antigen Receptor T Cells for Relapsed or Refractory Multiple Myeloma
Thomas Martin, MD 2021. "Anti-BCMA Chimeric Antigen Receptor T Cells for Relapsed or Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05577000.
~15 spots leftby Oct 2028
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top