ACTIVE_NOT_RECRUITING

Study of Anitocabtagene-autoleucel in Relapsed or Refractory Multiple Myeloma (iMMagine-1)

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A Phase II study of anitocabtagene-autoleucel (formerly CART-ddBCMA) for patients with relapsed or refractory multiple myeloma. Anitocabtagene-autoleucel is a BCMA-directed CAR-T cell therapy.

Official Title

A Phase II Study of CART-ddBCMA for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma

Quick Facts

Study Start:2022-08-09

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05396885

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age 18 years or older and has capacity to give informed consent 2. 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. 3. Documented measurable disease including at least one or more of the following criteria: 1. Serum M-protein ≥1.0 g/dL 2. Urine M-protein ≥200 mg/24 hours 3. Involved serum free light chain ≥10 mg/dL with abnormal κ/λ ratio (i.e., \>4:1 or \<1:2) 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 5. Life expectancy \>12 weeks 6. Adequate organ function defined as: 1. Oxygen (O2) saturation ≥92% on room air 2. Left Ventricular Ejection Fraction (LVEF) ≥45% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan 3. Absolute neutrophil count (ANC) ≥1.0k/µl, platelet count (PLT) 4. Creatinine clearance ≥45 mL/min min (as determined by the Cockgroft-Gault equation) and not on dialysis 5. Aspartate transaminase (AST)/alanine transaminase (ALT) \<3 x upper limits of normal (ULN) 6. Total bilirubin \<1.5 x ULN (allow 3x ULN for Gilbert's syndrome) 7. 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) 7. 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) 8. 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 9. 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 10. 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	1. Plasma cell leukemia or history of plasma cell leukemia 2. Treatment with the following therapies as specified below 1. Any prior systemic treatment for multiple myeloma within the 14 days prior to scheduled leukapheresis 2. Receiving high-dose (e.g., \>10 mg prednisone or equivalent) systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to leukapheresis 3. Prior treatment with any gene therapy or gene-modified cellular immune-therapy 4. Prior B-cell maturation antigen (BCMA) directed therapy 5. Autologous stem cell transplantation within 3 months prior to leukapheresis, or any prior allogeneic stem cell transplantation 3. Subjects with solitary plasmacytomas without evidence of other measurable disease are excluded 4. History of allergy or hypersensitivity to study drug components. Subjects with a history of severe hypersensitivity reaction to dimethyl sulphoxide (DMSO) are excluded 5. Contraindication to fludarabine or cyclophosphamide 6. Severe or uncontrolled intercurrent illness or laboratory abnormalities including 1. Active bacterial, viral, or fungal infection requiring systemic treatment (isolated fever may not constitute active infection in and of itself, (e.g., related to disease) 2. Symptomatic congestive heart failure (i.e., New York Heart Association stage III or IV) 3. Unstable angina, arrhythmia, or myocardial infarction (MI) within 6 months prior to Screening 4. Significant pulmonary dysfunction 5. Uncontrolled thromboembolic events or recent severe hemorrhage (i.e., within one year) 6. Any history of pulmonary embolism (PE) in the past 12 months or deep vein thrombosis (DVT) within three months of enrollment. Therapeutic dosing of anticoagulants (e.g., warfarin, low molecular weight heparin, Factor Xa inhibitors) is allowed for history of PE/DVT if greater than twelve and three months, respectively, from time of enrollment, and should be at a stable maintenance dose. 7. Auto-immune disease requiring immunosuppressive therapy within the last 24 months 7. Seropositive for and with evidence of active hepatitis B or C infection at time of Screening, or HIV seropositive 1. Subjects with a history of hepatitis B but have received antiviral therapy and have non-detectable viral DNA are eligible 2. Subjects seropositive because of hepatitis B virus vaccine with no signs or active infection are eligible 3. Subjects who had hepatitis C but have received antiviral therapy and show no detectable hepatitis C virus (HCV) viral RNA are eligible 8. Active central nervous system (CNS) involvement by malignancy 9. Any sign of active or prior CNS pathology including but not limited to history of epilepsy, seizure, paresis, aphasia, stroke, subarachnoid hemorrhage or CNS bleed, severe brain injury, dementia, cerebellar disease, Parkinson's disease, organic brain syndrome or psychosis 10. Active malignancy not related to myeloma that has required therapy in the last 3 years or is not in complete remission. Exceptions to this criterion include successfully treated non-metastatic basal cell or squamous cell skin carcinoma, or prostate cancer that does not require therapy. 11. Females who are pregnant or breastfeeding or females of childbearing potential not using an effective method of birth control 12. Subjects with any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in study (or full access to medical records) as written including follow up, the interpretation of data or place the subject at unacceptable risk 13. Any vaccine ≤ 6 weeks before leukapheresis and/or anticipation of the need for such a vaccine during the subject's participation in the study 14. Concurrent enrollment on another study using an investigational therapy for the treatment of RRMM

Inclusion Criteria

Exclusion Criteria

1. Age 18 years or older and has capacity to give informed consent
2. 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.
3. Documented measurable disease including at least one or more of the following criteria:
1. Serum M-protein ≥1.0 g/dL
2. Urine M-protein ≥200 mg/24 hours
3. Involved serum free light chain ≥10 mg/dL with abnormal κ/λ ratio (i.e., \>4:1 or \<1:2)
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
5. Life expectancy \>12 weeks
6. Adequate organ function defined as:
1. Oxygen (O2) saturation ≥92% on room air
2. Left Ventricular Ejection Fraction (LVEF) ≥45% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan
3. Absolute neutrophil count (ANC) ≥1.0k/µl, platelet count (PLT)
4. Creatinine clearance ≥45 mL/min min (as determined by the Cockgroft-Gault equation) and not on dialysis
5. Aspartate transaminase (AST)/alanine transaminase (ALT) \<3 x upper limits of normal (ULN)
6. Total bilirubin \<1.5 x ULN (allow 3x ULN for Gilbert's syndrome)
7. 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)
7. 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)
8. 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
9. 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
10. 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

1. Plasma cell leukemia or history of plasma cell leukemia
2. Treatment with the following therapies as specified below
1. Any prior systemic treatment for multiple myeloma within the 14 days prior to scheduled leukapheresis
2. Receiving high-dose (e.g., \>10 mg prednisone or equivalent) systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to leukapheresis
3. Prior treatment with any gene therapy or gene-modified cellular immune-therapy
4. Prior B-cell maturation antigen (BCMA) directed therapy
5. Autologous stem cell transplantation within 3 months prior to leukapheresis, or any prior allogeneic stem cell transplantation
3. Subjects with solitary plasmacytomas without evidence of other measurable disease are excluded
4. History of allergy or hypersensitivity to study drug components. Subjects with a history of severe hypersensitivity reaction to dimethyl sulphoxide (DMSO) are excluded
5. Contraindication to fludarabine or cyclophosphamide
6. Severe or uncontrolled intercurrent illness or laboratory abnormalities including
1. Active bacterial, viral, or fungal infection requiring systemic treatment (isolated fever may not constitute active infection in and of itself, (e.g., related to disease)
2. Symptomatic congestive heart failure (i.e., New York Heart Association stage III or IV)
3. Unstable angina, arrhythmia, or myocardial infarction (MI) within 6 months prior to Screening
4. Significant pulmonary dysfunction
5. Uncontrolled thromboembolic events or recent severe hemorrhage (i.e., within one year)
6. Any history of pulmonary embolism (PE) in the past 12 months or deep vein thrombosis (DVT) within three months of enrollment. Therapeutic dosing of anticoagulants (e.g., warfarin, low molecular weight heparin, Factor Xa inhibitors) is allowed for history of PE/DVT if greater than twelve and three months, respectively, from time of enrollment, and should be at a stable maintenance dose.
7. Auto-immune disease requiring immunosuppressive therapy within the last 24 months
7. Seropositive for and with evidence of active hepatitis B or C infection at time of Screening, or HIV seropositive
1. Subjects with a history of hepatitis B but have received antiviral therapy and have non-detectable viral DNA are eligible
2. Subjects seropositive because of hepatitis B virus vaccine with no signs or active infection are eligible
3. Subjects who had hepatitis C but have received antiviral therapy and show no detectable hepatitis C virus (HCV) viral RNA are eligible
8. Active central nervous system (CNS) involvement by malignancy
9. Any sign of active or prior CNS pathology including but not limited to history of epilepsy, seizure, paresis, aphasia, stroke, subarachnoid hemorrhage or CNS bleed, severe brain injury, dementia, cerebellar disease, Parkinson's disease, organic brain syndrome or psychosis
10. Active malignancy not related to myeloma that has required therapy in the last 3 years or is not in complete remission. Exceptions to this criterion include successfully treated non-metastatic basal cell or squamous cell skin carcinoma, or prostate cancer that does not require therapy.
11. Females who are pregnant or breastfeeding or females of childbearing potential not using an effective method of birth control
12. Subjects with any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in study (or full access to medical records) as written including follow up, the interpretation of data or place the subject at unacceptable risk
13. Any vaccine ≤ 6 weeks before leukapheresis and/or anticipation of the need for such a vaccine during the subject's participation in the study
14. Concurrent enrollment on another study using an investigational therapy for the treatment of RRMM

Contacts and Locations

Principal Investigator

Arcellx, Inc.

STUDY_DIRECTOR

Arcellx, Inc.

Study Locations (Sites)

HonorHealth Cancer Transplant Institute

Scottsdale, Arizona, 85258

United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205

United States

Colorado Blood Cancer Institute

Denver, Colorado, 80218

United States

Moffitt Cancer Center

Tampa, Florida, 33612

United States

Northside Hospital

Atlanta, Georgia, 30342

United States

University of Chicago Medical Center

Chicago, Illinois, 60637

United States

University of Maryland Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, 21201

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115

United States

Karmanos Cancer Institute

Detroit, Michigan, 48201

United States

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601

United States

Levine Cancer Institute

Charlotte, North Carolina, 28204

United States

Oregon Health & Science University (OHSU)

Portland, Oregon, 97239

United States

University of Texas Southwestern Medical Center

Dallas, Texas, 75390

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

United States

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, 84112

United States

University of Wisconsin Clinical Science Center

Madison, Wisconsin, 53792

United States

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Kite, A Gilead Company

Arcellx, Inc., STUDY_DIRECTOR, Arcellx, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-09

Study Completion Date2026-12

Study Record Updates

Study Start Date2022-08-09

Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

Multiple Myeloma