A Phase 1/2 Study of a Fully Human BCMA-targeting CAR (CT103A) in Patients With Relapsed/Refractory Multiple Myeloma (FUMANBA-1)

NCT05066646 | Unknown Phase 1 DMC

• 1 other identifier: XL-LCYJ-0007
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 14

Brief Summary

This study is a single-armed, open-label, multicenter Phase 1/2 study to evaluate the efficacy and safety of CT103A in subjects with relapsed and refractory MM.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (5)

• Phase 1: Incidence and Severity of Adverse Events

  An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

  Minimum of 2 years post CT103A infusion

• Phase 1: Laboratoty tests

  Abnormal results of laboratoty tests

  Minimum of 2 years post CT103A infusion

• Phase 1: Vital signs

  Abnormal results of vital signs

  Minimum of 2 years post CT103A infusion

• Phase 1: Physical examination

  Abnormal results of physical examination

  Minimum of 2 years post CT103A infusion

• Phase 2: Overall response rate (ORR) evaluated by an Independent Review Committee (IRC)

  Percentage of subjects who achieved partial response (PR) or better according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by an IRC

  3 months post CT103A infusion

Secondary Outcomes (14)

• Overall response rate (ORR) evaluated by the investigators

  3 months post CT103A infusion

• Overall Survival (OS)

  Minimum of 2 years post CT103A infusion

• Duration of Response (DOR)

  Minimum of 2 years post CT103A infusion

• Progression-free Survival (PFS)

  Minimum of 2 years post CT103A infusion

• Time to Response (TTR)

  Minimum of 2 years post CT103A infusion

Other Outcomes (3)

• Immunogenicity

  Minimum of 2 years post CT103A infusion

• replication competent lentivirus (RCL)

  Minimum of 2 years post CT103A infusion

• the levels of CAR-T related inflammatory factors

  Minimum of 2 years post CT103A infusion

Study Arms (1)

CT103A in relapsed and refractory multiple myeloma patients

EXPERIMENTAL

CT103A autologous CAR-T cells will be infused at RP2D of 1.0 x 10\^6 CAR+ T cells after receiving lymphodepleting chemotherapy

Drug: CT103A

Interventions

CT103A DRUG

CT103A consists of autologous T lymphocytes transduced with anti-BCMA CAR lentiviral vector that containing a unique CAR structure with a fully human single-chain variable fragment (scFv).

CT103A in relapsed and refractory multiple myeloma patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must satisfy all the following criteria to be enrolled in the study:
• age 18 to 70 years old, male or female.
• Subjects with diagnosed relapsed or refractory MM according to IMWG criteria and have had at least 3 prior lines of therapy including chemotherapy based on proteasome inhibitors (PIs) and immunomodulatory agents (IMiDs). Disease progression must be documented during or within 12 months following the most recent anti-myeloma treatment.
• Evidence of cell membrane BCMA expression, as determined by a validated immunohistochemistry (IHC) or flow cytometry of tumor tissue (e.g., bone marrow biopsies, or plasmacytoma).
• The subjects should have measurable disease based on at least one of the following parameters:
• The proportion of primitive immature or monoclonal plasma cells detected by bone marrow cytology, bone marrow biopsy, or flow cytometry is ≥ 5%.
• Serum M-protein ≥ 0.5 g/dL.
• Urine M-protein ≥ 200 mg/24 hrs.
• For those whose Serum or Urine M-protein does not meet the measurable criteria but the light chain type, serum free light chain (sFLC): involved sFLC level ≥ 10 mg/dL (100 mg/L) provided serum FLC ratio is abnormal.
• ECOG performance score 0-1.
• Estimated life expectancy ≥ 12 weeks.
• Patients should have adequate organ function:
• Hematology: Absolute neutrophil count (ANC) ≥1×10\^9 /L (prior use of growth factor support is permitted, but subjects must not have received supportive treatment within 7 days prior to laboratory examination); absolute lymphocyte count (ALC) ≥0.3×10\^9 /L; platelets ≥50×10\^9 /L (subjects must not have received blood transfusion support within 7 days prior to laboratory examination); hemoglobin ≥60 g/L (subjects must not have received transfusion of red blood cells \[RBC\] within 7 days prior to laboratory examination; the use of recombinant human erythropoietin is permitted).
• Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×upper limit of normal (ULN); total serum bilirubin ≤ 1.5×ULN.
• Renal function: Creatinine clearance rate (CrCl) calculated according to Cockcroft-Gault formula ≥ 40 ml/min.

You may not qualify if:

• The presence of any of the following will exclude a subject from enrollment:
• Subjects who are known to have GVHD or need long-term immunosuppressive therapy.
• Subjects have received an autologous hematopoietic stem cell transplantation (auto-HSCT) within 12 weeks before leukapheresis or have a previous history of two times of allo-HSCT or previous history of an allogeneic hematopoietic stem cell transplantation (allo-HSCT).
• Insufficient mononuclear cells for CAR T cell production.
• Subjects have received any anti-cancer treatment as follows: targeted therapies, epigenetic therapy or invasive experimental instruments therapy within 14 days or at least 5 half-lives before leukapheresis (according to the longer time), or monoclonal antibody for treating multiple myeloma within 21 days before leukapheresis, or cytotoxic therapy or proteasome inhibitors within 14 days before leukapheresis, or immunomodulatory agents within 7 days before leukapheresis.
• Subjects who were receiving a used therapeutic dose of corticosteroid treatment (defined as prednisone or equivalent \> 20mg) within 7 days prior to screening, except for physiological alternatives, inhalation, or topical use.
• Subjects with serious heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (NYHA classification ≥III), and severe arrhythmias.
• Subjects with systemic diseases that the investigator determined to be unstable include, but are not limited to, severe liver and kidney or metabolic diseases requiring medical treatment.
• Subjects with second malignancies in addition to MM within the past 5 years before the screening, exceptions to this criterion: successfully treated cervical carcinoma in situ and non-metastatic basal or squamous cell skin carcinoma, local prostate cancer after radical surgery, and ductal carcinoma in situ of the breast after radical surgery.
• Subjects with a history of organ transplantation.
• Subjects have central nervous system (CNS) involvement (including cranial neuropathies or mass lesions and leptomeningeal disease).
• Subjects with extramedullary lesions (except for a single extramedullary lesion with a maximum transverse diameter of 3 cm).
• Subjects with plasma cell leukemia.
• Subjects have received major surgery within 2 weeks prior to leukapheresis or plan to receive surgery during the study or within 2 weeks after the study treatment (excluding local anesthesia).
• Subjects participated in another interventional clinical study 3 months before signing the informed consent (ICF);

Sponsors & Collaborators

• Nanjing IASO Biotechnology Co., Ltd.: lead

Study Sites (14)

Anhui Provincial Cancer Hospital

Hefei, Anhui, China

RECRUITING

The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital

Zhengzhou, Henan, China

RECRUITING

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

Wuhan, Hubei, China

RECRUITING

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

RECRUITING

Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

The Affiliated Hospital of Nanjing University Medical School, Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

RECRUITING

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

Beijing Boren Hospital

Beijing, China

RECRUITING

Peking University First Hospital

Beijing, China

RECRUITING

Xinqiao Hospital, Army Medical University

Chongqing, China

RECRUITING

Fudan University Zhongshan Hospital

Shanghai, China

RECRUITING

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

RECRUITING

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Tianjin, China

RECRUITING

Related Publications (2)

• Keam SJ. Equecabtagene Autoleucel: First Approval. Mol Diagn Ther. 2023 Nov;27(6):781-787. doi: 10.1007/s40291-023-00673-y. Epub 2023 Sep 2.

  PMID: 37658205 DERIVED

• Zhou L, Fu W, Wu S, Xu K, Qiu L, Xu Y, Yan X, Zhang Q, Zhang M, Wang L, Hong R, Chang AH, Yu J, Fu S, Kong D, Li L, Wang Y, Li Z, Jiang H, Huang J, Liu Z, Su N, Wei G, Hu Y, Huang H. Derivation and validation of a novel score for early prediction of severe CRS after CAR-T therapy in haematological malignancy patients: A multi-centre study. Br J Haematol. 2023 Aug;202(3):517-524. doi: 10.1111/bjh.18873. Epub 2023 May 16.

  PMID: 37192741 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

CT103A chimeric antigen receptor

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 Officials

• Lugui Qiu, MD, PhD

  Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

  PRINCIPAL INVESTIGATOR

• Chunrui Li, MD, PhD

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Songbai Cai

CONTACT

+86 025-58287610; simon@iasobio.com

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: September 22, 2021
• First Posted: October 4, 2021
• Study Start: April 1, 2020
• Primary Completion: October 1, 2022
• Study Completion: June 1, 2024
• Last Updated: November 23, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (14)