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Safety and Efficacy of ALLO-605 an Anti-BCMA Allogeneic CAR T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05000450
Recruitment Status : Recruiting
First Posted : August 11, 2021
Last Update Posted : February 11, 2022
Sponsor:
Information provided by (Responsible Party):
Allogene Therapeutics

Tracking Information
First Submitted Date  ICMJE August 4, 2021
First Posted Date  ICMJE August 11, 2021
Last Update Posted Date February 11, 2022
Actual Study Start Date  ICMJE June 6, 2021
Estimated Primary Completion Date January 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2021)
  • 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. [ Time Frame: 28 days ]
    Dose limiting toxicity is defined as protocol-defined ALLO-605 related adverse events with onset within 28 days following infusion
  • Phase 1: Proportion of patients experiencing Dose Limiting Toxicities with ALLO-647 [administered in combination with fludarabine/cyclophosphamide administered prior to ALLO-605] [ Time Frame: 30 days ]
    Dose-limiting toxicity is defined as protocol-defined ALLO-647-related adverse events with onset within 30 days following 1st infusion
  • Phase 2: To assess clinical efficacy of ALLO-605 as measured by overall response rate (ORR) [ Time Frame: 12 months of study follow-up ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of ALLO-605 an Anti-BCMA Allogeneic CAR T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma
Official Title  ICMJE A Single-Arm, Open-Label, Phase 1/2 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-647 and ALLO-605, an Anti- BCMA Allogeneic CAR T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Relapsed/Refractory Multiple Myeloma
Intervention  ICMJE
  • Genetic: ALLO-605
    ALLO-605 is an anti-BCMA, TRAC/CD52 allogeneic edited, intracellular cytokine signaling containing, CAR T cell product
  • Biological: ALLO-647
    ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
  • Drug: Fludarabine
    Chemotherapy for lymphodepletion
  • Drug: Cyclophosphamide
    Chemotherapy for lymphodepletion
Study Arms  ICMJE Experimental: ALLO-605, ALLO-647
Interventions:
  • Genetic: ALLO-605
  • Biological: ALLO-647
  • Drug: Fludarabine
  • Drug: Cyclophosphamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 4, 2021)
136
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2027
Estimated Primary Completion Date January 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Allogene 415-650-0034 clinicaltrials@allogene.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05000450
Other Study ID Numbers  ICMJE ALLO-605-201
IGNITE Study ( Other Identifier: Allogene )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Allogene Therapeutics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Allogene Therapeutics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Allogene Therapeutics
Verification Date February 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP