NCT05000450

Brief Summary

The purpose of the ALLO-605-201 study is to assess the safety, efficacy, and cell kinetics of ALLO605 in adults with relapsed or refractory multiple myeloma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2021

Typical duration for phase_1

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 6, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 11, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2023

Completed
Last Updated

June 28, 2024

Status Verified

June 1, 2024

Enrollment Period

2.3 years

First QC Date

August 4, 2021

Last Update Submit

June 27, 2024

Conditions

Relapsed/Refractory Multiple Myeloma

Keywords

CAR TCell TherapyAllogeneic Cell TherapyCellular Immuno-therapyAlloCAR TALLO-605ALLO-647Multiple Myeloma

Outcome Measures

Primary Outcomes (3)

  • 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.

    Dose limiting toxicity is defined as protocol-defined ALLO-605 related adverse events with onset within 28 days following infusion

    28 days

  • Phase 1: Proportion of patients experiencing Dose Limiting Toxicities with ALLO-647 [administered in combination with fludarabine/cyclophosphamide administered prior to ALLO-605]

    Dose-limiting toxicity is defined as protocol-defined ALLO-647-related adverse events with onset within 30 days following 1st infusion

    30 days

  • Phase 2: To assess clinical efficacy of ALLO-605 as measured by overall response rate (ORR)

    12 months of study follow-up

Study Arms (1)

ALLO-605, ALLO-647

EXPERIMENTAL
Genetic: ALLO-605Biological: ALLO-647Drug: FludarabineDrug: Cyclophosphamide

Interventions

ALLO-605GENETIC

ALLO-605 is an anti-BCMA, TRAC/CD52 allogeneic edited, intracellular cytokine signaling containing, CAR T cell product

ALLO-605, ALLO-647
ALLO-647BIOLOGICAL

ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen

ALLO-605, ALLO-647
FludarabineDRUG

Chemotherapy for lymphodepletion

ALLO-605, ALLO-647
CyclophosphamideDRUG

Chemotherapy for lymphodepletion

ALLO-605, ALLO-647

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented diagnosis of relapsed/refractory multiple myeloma (MM)
  • Subjects must have measurable disease
  • Subjects must have received ≥3 prior MM lines of therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate hematologic, renal, liver, pulmonary, and cardiac functions
  • Life expectancy of at least 3 months without treatment

You may not qualify if:

  • Subjects with known active or history of central nervous system (CNS) or leptomeningeal involvement of myeloma or plasma cell leukemia
  • Current or history of thyroid disorder (including hyperthyroidism), except for subjects with hypothyroidism controlled on a stable dose of hormone replacement therapy
  • Autologous stem cell transplantation within last 6 weeks prior to the start of lymphodepletion
  • Any prior allogeneic hematopoietic stem cell transplantation
  • Systemic anti-cancer therapy within 2 weeks prior to the start of lymphodepletion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Sarah Cannon/Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

Location

St. David's South Austin Medical Center

Austin, Texas, 78704, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Texas Transplant Institute

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

fludarabineCyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2021

First Posted

August 11, 2021

Study Start

June 6, 2021

Primary Completion

October 11, 2023

Study Completion

October 11, 2023

Last Updated

June 28, 2024

Record last verified: 2024-06

Locations

US(4)