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CAR T-cell Therapy

Anti-BCMA CAR-T Cells for Multiple Myeloma

Phase 1

Waitlist Available

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

Must not have

Autologous transplant within 6 weeks of planned CAR-T cell infusion

Pregnant or breastfeeding women are excluded from this study because CAR-T cell therapy may be associated with the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with CAR-T cells, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study. NOTE: Women of childbearing potential must have a negative serum or urine pregnancy test

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

No Placebo-Only Group

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.

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.

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

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I am fully active or can carry out light work.

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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.

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I have MM and it didn't respond to at least 3 treatments including a PI, an IMiD, and anti-CD38 therapy.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had a stem cell transplant using my own cells less than 6 weeks ago.

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I am not pregnant or breastfeeding and have a negative pregnancy test.

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I do not have active brain conditions like seizures, stroke, or Parkinson's.

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I am experiencing symptoms that suggest a brain or nerve condition.

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I have hepatitis but my PCR test for it is negative.

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I do not have any severe illnesses that would stop me from following the study's requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Duration of response

Overall Survival

Progression-free Survival (PFS)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Group III: Dose Escalation (450 x 10^6 CAR + T cells/ infusion)Experimental Treatment3 Interventions

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

2010

Completed Phase 4

~2310

Fludarabine

2012

Completed Phase 4

~1860