BCMA-directed CAR-T Cell Therapy in Adult Patients With Multiple Myeloma

NCT04318327 | Terminated Phase 1 FDA Drug

• 1 other identifier: CADPT07A12101
• Study Type: interventional
• Target: 96
• Locations: 4 countries
• Sites: 9

Brief Summary

This was a first-in-human study to evaluate the feasibility, safety and preliminary antitumor efficacy of autologous T cells genetically engineered with a novel B-cell Maturation Antigen (BCMA)-specific chimeric antigen receptor (CAR) and manufactured with a new process. CAR-T cells were investigated as a single agent in multiple myeloma

Conditions

Multiple Myeloma

Keywords

Multiple myeloma; B-cell maturation antigen; BCMA; anti-BCMA; BCMA-directed; chimeric antigen receptor; CAR-T; PHE885

Outcome Measures

Primary Outcomes (3)

• Incidence of Dose limiting toxicities (DLT)

  Incidence of Dose Limiting Toxicities (DLTs) during the first 28 days after anti-BCMA CAR-T cell administration

  28 days

• Nature of Dose limiting toxicities (DLT)

  Nature of Dose Limiting Toxicities (DLTs) during the first 28 days after anti-BCMA CAR-T cell administration

  28 days

• Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

  24 months

Secondary Outcomes (16)

• Manufacture success rate (defined as number of subjects treated with planned target dose divided by total number of subjects treated)

  24 Months

• Overall Response Rate (ORR) in Part A

  24 months

• ORR in Part B

  24 months

• Response rate at 3 and 6 months in Part A

  3 months, 6 months

• Overall response rate at 3 and 6 months in Part B

  3 months, 6 months

Study Arms (2)

PHE885 (Part A)

EXPERIMENTAL

Relapsed and/or refractory multiple myeloma (r/r MM) patients will receive PHE885.

Biological: PHE885

PHE885 (Part B)

EXPERIMENTAL

Newly diagnosed multiple myeloma (NDMM) patients will receive PHE885.

Biological: PHE885

Interventions

PHE885 BIOLOGICAL

Infusion

PHE885 (Part A); PHE885 (Part B)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Part A: Subjects with MM who are relapsed and/or refractory to at least 2 prior treatment regimens, including an IMiD (e.g. lenalidomide or pomalidomide), a proteasome inhibitor (e.g. bortezomib, carfilzomib), and an approved anti-CD38 antibody (e.g. daratumumab), if available, and have documented evidence of disease progression (IMWG criteria)
• Part A: ECOG performance status that is either 0 or 1 at screening
• Part B: Subjects with newly diagnosed multiple myeloma (NDMM) who have received a minimum of 4 and up to 6 cycles of standard induction therapy with VRd, D-VRd, or D-Rd, and have achieved a response of PR or better. One cycle of CyBorDex is allowed prior to induction.
• Part B: ECOG performance status that is either 0,1 or 2 at screening
• Measurable disease as defined by the protocol
• Adequate hematological values
• Must have a leukapheresis material of non-mobilized cells accepted for manufacturing

You may not qualify if:

• Prior administration of a genetically modified cellular product including prior BCMA CAR-T therapy. Patients who have received prior BCMA-directed bi-specific antibodies or antibody-drug conjugates (ADC) are not excluded.
• Autologous HSCT within 6 weeks prior to enrollment or any prior history of allogeneic hematopoietic stem cell transplant (HSCT)
• Chemotherapy or any concomitant anti-cancer therapies (other than protocol prescribed lymphodepletion (LD) chemotherapy) within 2 weeks prior to apheresis
• Treatment with small molecule targeted antineoplastics within 2 weeks of apheresis collection or 5 half-lives whichever is shorter
• Have received antibodies or immunotherapies (other than daratumumab) within 4 weeks prior to apheresis collection. Daratumumab within 3 weeks prior to apheresis collection.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (9)

Uni of Chi Medi Ctr Hema and Onco

Chicago, Illinois, 60637, United States

Location

Beth Israel Deaconess Medical Cente

Boston, Massachusetts, 02215, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Novartis Investigative Site

Melbourne, Victoria, 3004, Australia

Location

Novartis Investigative Site

Ramat Gan, 5265601, Israel

Location

Novartis Investigative Site

Tel Aviv, 6423906, Israel

Location

Novartis Investigative Site

Singapore, 119074, Singapore

Location

Novartis Investigative Site

Singapore, 169608, Singapore

Location

Related Links

• CADPT07A12101 Clinical Trial Results

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; 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

Study Design

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

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 23, 2020
• Study Start: July 23, 2020
• Primary Completion: April 29, 2025
• Study Completion: April 29, 2025
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2); SG (2); US (4); AU (1)