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CAR T-cell Therapy

CART-ddBCMA for Multiple Myeloma

Phase 2
Recruiting
Research Sponsored by Arcellx, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate organ function defined as: Oxygen (O2) saturation ≥92% on room air, Left Ventricular Ejection Fraction (LVEF) ≥45% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan, Absolute neutrophil count (ANC) ≥1.0k/µl, platelet count (PLT) ≥50k/µl, Creatinine clearance ≥45 mL/min min (as determined by the Cockgroft-Gault equation) and not on dialysis, Aspartate transaminase (AST)/alanine transaminase (ALT) <3 x upper limits of normal (ULN), Total bilirubin <1.5 x ULN (allow 3x ULN for Gilbert's syndrome), Prothrombin time test (PTT), prothrombin time (PT)/international normalized ratio (INR) <1.5 x ULN, unless on a stable dose of anti-coagulant for a thromboembolic event (Subjects with any history of thromboembolic stroke; or history or Grade 2 (G2) or greater hemorrhage within one year are excluded), Resolution of adverse events (AEs) from any prior systemic anticancer therapy, radiotherapy, or surgery to Grade 1 or baseline (except G2 alopecia and G2 sensory neuropathy), Male and female participants of childbearing potential must agree to use highly effective methods of birth control through 12 months after the dose of study treatment, Willing to comply with and able to tolerate study procedures, including consent to participate in separate Long-term Safety Follow-up lasting up to 15 years per FDA guidance, Subject's leukapheresis product from non-mobilized cells is received and accepted for cell processing by manufacturing site. NOTE: Leukapheresis will be performed only after all other eligibility criteria are confirmed
Relapsed or refractory multiple myeloma treated with at least 3 prior regimens of systemic therapy including proteasome inhibitor, immunomodulatory drugs (IMiD) and anti-CD38 antibody and are refractory to the last line of therapy. For each line, 2 consecutive cycles are required unless the best response after 1 cycle was progressive disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing a new cancer treatment that uses a patient's own immune cells to target and destroy cancer cells.

Who is the study for?
Adults with relapsed or refractory multiple myeloma who have tried at least three prior treatments, including proteasome inhibitors, IMiDs, and anti-CD38 antibodies. They must show measurable disease signs, be in good physical condition (ECOG 0-1), have a life expectancy over 12 weeks, and proper organ function. Participants should not be pregnant or breastfeeding and must agree to use effective birth control for a year post-treatment.Check my eligibility
What is being tested?
The trial is testing CART-ddBCMA, which is a type of CAR-T cell therapy targeting BCMA on cancer cells. It's for patients whose multiple myeloma has returned after treatment or hasn't responded to standard therapies. The study will assess the safety and effectiveness of this new intervention.See study design
What are the potential side effects?
CAR-T cell therapies like CART-ddBCMA can cause cytokine release syndrome (flu-like symptoms such as fever and fatigue), neurological effects (confusion or difficulty speaking), low blood cell counts leading to increased infection risk, bleeding issues, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You need to have good organ function and meet specific blood test values. You must also agree to use effective birth control if you can have children. You need to be able to follow the study procedures and consent to a long-term safety follow-up.
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My multiple myeloma has not responded to 3 types of treatments including a proteasome inhibitor, IMiD, and anti-CD38 antibody.
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I am fully active or can carry out light work.
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I am 18 or older and can understand and agree to the study's details.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months 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)
Secondary outcome measures
Anti-CART-ddBCMA Antibodies
Duration of Response (DoR)
Health Related Quality of Life (HRQoL)
+10 more

Awards & Highlights

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: CART-ddBCMAExperimental Treatment1 Intervention
Single dose of 115±10 x 10e-6 CAR+ CART-ddBCMA cells infused intravenously

Find a Location

Who is running the clinical trial?

Multiple Myeloma Research FoundationOTHER
10 Previous Clinical Trials
3,467 Total Patients Enrolled
10 Trials studying Multiple Myeloma
3,467 Patients Enrolled for Multiple Myeloma
Kite, A Gilead CompanyIndustry Sponsor
42 Previous Clinical Trials
3,476 Total Patients Enrolled
2 Trials studying Multiple Myeloma
33 Patients Enrolled for Multiple Myeloma
Arcellx, Inc.Lead Sponsor
2 Previous Clinical Trials
89 Total Patients Enrolled
1 Trials studying Multiple Myeloma
65 Patients Enrolled for Multiple Myeloma

Media Library

CART-ddBCMA (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05396885 — Phase 2
Multiple Myeloma Research Study Groups: CART-ddBCMA
Multiple Myeloma Clinical Trial 2023: CART-ddBCMA Highlights & Side Effects. Trial Name: NCT05396885 — Phase 2
CART-ddBCMA (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05396885 — Phase 2

Frequently Asked Questions

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

What are the risks associated with CART-ddBCMA treatment?

"CART-ddBCMA falls into the category of a Phase 2 trial, which means that while there is some evidence supporting its safety, none exists for its efficacy. Therefore, it received a score of 2."

Answered by AI

Are individuals with the relevant medical condition able to enroll in this trial at this time?

"According to the latest update on clinicaltrials.gov, this study is not currently looking for new participants. This trial was first posted on July 15th, 2022 and was last updated on July 7th, 2022. 827 other trials are actively recruiting patients right now."

Answered by AI
~16 spots leftby May 2024