QUILT-3.020: A Study of ALT-801 in Patients With Relapsed or Refractory Multiple Myeloma

NCT01670994 | Terminated Phase 1 Results DMC

• 1 other identifier: CA-ALT-801-01-11
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase Ib/II, open-label, multi-center and competitive enrollment study of ALT-801 in patients who have relapsed or refractory multiple myeloma.

Conditions

Relapsed or Refractory Multiple Myeloma

Keywords

cancer; immunotherapy; immunochemotherapy; targeted; metastatic; interleukin-2; antitumor; TCR; T-cell receptor; p53; p53 gene; p53 tumor supressor protein; HLA-A2 positive; HLA-A*0201/p53 aa264-272; HLA complex; multiple myeloma; IFN-γ and TNF-α; refractory; relapsed

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Related Adverse Events

  Number of treatment related AEs that occur or worsen after the first dose of study treatment

  7 weeks

Study Arms (2)

ALT-801 0.04mg/kg

EXPERIMENTAL

Biological: ALT-801

ALT-801 0.06mg/kg

EXPERIMENTAL

Biological: ALT-801

Interventions

ALT-801 BIOLOGICAL

Intravenous infusion; 2 treatment cycles: on day 1, 3, 8, and 15 of each cycle

Also known as: c264scTCR-IL2

ALT-801 0.04mg/kg; ALT-801 0.06mg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

ENTRY CRITERIA: DISEASE CHARATERISTICS: * Confirmed diagnosis of relapsed/refractory multiple myeloma after treatment with at least two different previous regimens. * Refractory disease is defined as progressive disease while on therapy or progression within 60 days of therapy. * Progressive disease is defined by a 25% increase from the lowest response value in specified tests. * Measurable disease as defined by at least one of the following: * Serum M-protein ≥ 1g/dL (for IgG, IgM) or 0.5 g/dL (for IgA) * Urine M-protein ≥ 200mg/24hours * Serum free light chains ≥ 10 mg/dL and abnormal kappa/lambda ratio PRIOR/CONCURRENT THERAPY: * No anti-myeloma treatments within 28 days before the start of study treatment. * Must have recovered from side effects of prior treatments. PATIENT CHARACTERISTICS: Age • ≥ 18 years Performance Status • ECOG 0, 1, or 2 Bone Marrow Reserve * Absolute neutrophil count (AGC/ANC) ≥ 1,000/uL * Platelets ≥ 30,000/uL * Hemoglobin ≥ 8g/dL Renal Function • Glomerular Filtration Rate (GFR) \> 45mL/min/1.73m\^2 Hepatic Function * Total bilirubin ≤ 2.0 X ULN * AST, ALT, ALP ≤ 3.0 X ULN, or ≤ 5.0 X ULN (if liver metastases exist) Cardiovascular * No congestive heart failure \< 6 months * No unstable angina pectoris \< 6 months * No myocardial infarction \< 6 months * No history of ventricular arrhythmias * No history of supraventricular arrhythmias * No NYHA Class \> II CHF * Normal Transthoracic Echocardiogram (TTE) is required for patients with history of EKG abnormalities, CHF, coronary artery disease or other cardiac disease, or with a history of having received adriamycin or doxorubicin * Patients with a left ventricular ejection fraction (LVEF) of less than 50% will be excluded from study entry Pulmonary • Normal clinical assessment of pulmonary function Other * Negative serum pregnancy test if female and of childbearing potential * Women who are not pregnant or nursing * Subjects, both females and males, with reproductive potential must agree to use effective contraceptive measures for the duration of the study * No known autoimmune disease other than corrected hypothyroidism * No known prior organ allograft or allogeneic transplantation * Not HIV positive * No history or evidence of uncontrollable CNS disease * No psychiatric illness/social situation * No other illness that in the opinion of the investigator would exclude the subject from participating in the study * Must provide informed consent and HIPPA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations * Active systemic infection requiring parenteral antibiotic therapy. * No ongoing chronic systemic steroid therapy required.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Altor BioScience: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Iowa Hospitals

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Recurrence; Multiple Myeloma; Neoplasms; Neoplasm Metastasis

Interventions

ALT-801

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Neoplastic Processes

Results Point of Contact

• Title: Sandeep Bobby Reddy, Chief Medical Officer
• Organization: ImmunityBio

Bobby.Reddy@Immunitybio.com

855-797-9277

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: August 20, 2012
• First Posted: August 23, 2012
• Study Start: August 14, 2012
• Primary Completion: September 9, 2015
• Study Completion: September 9, 2015
• Last Updated: June 18, 2024
• Results First Posted: June 18, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)