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CAR T-cell Therapy

Anti-BCMA CAR T Cell Therapy for Multiple Myeloma

Phase 1 & 2
Waitlist Available
Research Sponsored by Allogene Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Documented diagnosis of relapsed/refractory multiple myeloma (MM)
Subjects must have received ≥3 prior MM lines of therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months of study follow-up
Awards & highlights

Study Summary

This trial is testing a new cancer treatment on adults with relapsed or refractory multiple myeloma.

Who is the study for?
This trial is for adults with relapsed or refractory multiple myeloma who have tried at least three other treatments and still have measurable disease. They should be relatively healthy, with a life expectancy of at least 3 months without treatment, and good heart, lung, kidney, liver, and blood function.Check my eligibility
What is being tested?
The study tests ALLO-605 CAR T cell therapy after patients receive a lymphodepletion regimen (a process to reduce white blood cells) that includes fludarabine, cyclophosphamide, and ALLO-647. The goal is to see how safe it is and how well it works against multiple myeloma.See study design
What are the potential side effects?
Possible side effects may include reactions related to the immune system attacking normal cells while targeting cancer cells (like inflammation), as well as those associated with chemotherapy such as nausea, fatigue, low blood counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My multiple myeloma has come back or didn't respond to treatment.
Select...
I have undergone 3 or more treatments for multiple myeloma.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months of study follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months of study follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1: Proportion of patients experiencing Dose Limiting Toxicities with ALLO-647 [administered in combination with fludarabine/cyclophosphamide administered prior to ALLO-605]
Phase 1: Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-605 that will determine MTD/MAD and select the recommended Phase 2 dose (RP2D) of ALLO-605.
Phase 2: To assess clinical efficacy of ALLO-605 as measured by overall response rate (ORR)

Trial Design

1Treatment groups
Experimental Treatment
Group I: ALLO-605, ALLO-647Experimental Treatment4 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Fludarabine
2012
Completed Phase 3
~1080

Find a Location

Who is running the clinical trial?

Allogene TherapeuticsLead Sponsor
5 Previous Clinical Trials
556 Total Patients Enrolled
1 Trials studying Multiple Myeloma
132 Patients Enrolled for Multiple Myeloma

Media Library

ALLO-605 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05000450 — Phase 1 & 2
ALLO-605 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05000450 — Phase 1 & 2
Multiple Myeloma Clinical Trial 2023: ALLO-605 Highlights & Side Effects. Trial Name: NCT05000450 — Phase 1 & 2
Multiple Myeloma Research Study Groups: ALLO-605, ALLO-647
~37 spots leftby Jul 2025
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