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Multiple MyelomaPhase 1/2FUMANBA-1NCT05066646

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

A Phase 1/2 study testing CT103A in people with Multiple Myeloma, run by Nanjing IASO Biotechnology Co., Ltd. at 14 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Multiple Myeloma
What is being tested?
CT103A
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
14 sitesChina
Study dates
1 Apr 2020to Jun 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%.
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  • 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.
  • Coagulation function: Fibrinogen ≥ 1.0 g/L; activated partial thromboplastin time (APTT) ≤ 1.5×ULN, prothrombin time (PT) ≤ 1.5×ULN.
  • SpO2 > 91%.
  • Left ventricular ejection fraction (LVEF) ≥ 50%.
  • The subject and his/her spouse agree to use an effective contraceptive tool or medication (excluding safety period contraception) for one year from the date of the subject's informed consent to the date of CAR T cell infusion.
  • Subject must sign the informed consent form approved by ethics board in person before starting any screening procedure.

Who cannot join

  • 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.
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  • 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);
  • Subjects with any uncontrolled active infection needed to receive systemic therapy within 7 days before leukapheresis collection (excluding < CTCAE grade 2 urogenital infection and upper respiratory infection).
  • Positive for any of the following tests:
  • Hepatitis B virus (HBV) surface antigen (HBsAg) or hepatitis B core antibody-positive and detectable HBV DNA in peripheral blood
  • Hepatitis C virus (HCV) antibody and hepatitis C virus RNA in peripheral blood
  • Human immunodeficiency virus (HIV) antibody
  • Cytomegalovirus (CMV) DNA
  • Treponema Pallidum antibody
  • Pregnant or lactating women.
  • Subjects with mental illness or consciousness disorder or disease of the central nervous system
  • Subjects who haven't recovery to Grade 1 or baseline of any toxicities due to prior treatments, excluding alopecia.
  • Other conditions that researchers consider inappropriate for inclusion.

Trial locations and contacts

14 sites in 1 country.

Songbai Cai contact

+86 025-58287610

simon@iasobio.com

14 sites in 1 country

China14 sites, 14 recruiting

  • Beijing Boren Hospital

    Beijing

    Kai Hu

    Recruiting

  • Peking University First Hospital

    Beijing

    Hanyun Ren

    Recruiting

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan

    Jing Liu

    Recruiting

  • Xinqiao Hospital, Army Medical University

    Chongqing

    Xi Zhang

    Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang

    He Huang

    Recruiting

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui

    Kaiyang Ding

    Recruiting

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

    Nanjing, Jiangsu

    Jianyong Li

    Recruiting

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

    Nanjing, Jiangsu

    Bing Chen

    Recruiting

  • Fudan University Zhongshan Hospital

    Shanghai

    Peng Liu

    Recruiting

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai

    Jianqing Mi

    Recruiting

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

    Tianjin

    Lugui Qiu

    Recruiting

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

    Wuhan, Hubei

    Chunrui Li

    Recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu

    Zhenyu Li

    Recruiting

  • The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital

    Zhengzhou, Henan

    Yongping Song

    Recruiting

Other trials in China

About this study

Official title: Phase 1/2 Clinical Study on Fully Human BCMA Chimeric Antigen Receptor Autologous T Cell Injection (CT103A) in the Treatment of Patients With Relapsed/Refractory Multiple Myeloma

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.

Read the detailed description

Leukapheresis procedure will be performed to manufacture CT103A chimeric antigen receptor (CAR) modified T cells. Bridging therapy is allowed between PBMC collection and lymphodepletion. Lymphodepletion with fludarabine and cyclophosphamide was performed for three consecutive days. After 1-day rest, subjects will receive a single dose infusion of CT103A at 1.0 x 10^6 CAR+ T cells/Kg. Subjects will be followed in the study for a minimum of 2 years after CT103A infusion. Long-term follow-up for lentiviral vector safety will be followed for up to 15 years after CT103A infusion.

Being tested
CT103A
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CT103ADrug

    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).

Study groups in NCT05066646
Study groupRoleWhat they receive
CT103A in relapsed and refractory multiple myeloma patientsExperimentalCT103A autologous CAR-T cells will be infused at RP2D of 1.0 x 10^6 CAR+ T cells after receiving lymphodepleting chemotherapy
Receives: Drug: CT103A

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Minimum of 2 years post CT103A infusion

  2. Phase 1: Laboratoty tests

    Abnormal results of laboratoty tests

    Measured: Minimum of 2 years post CT103A infusion

  3. Phase 1: Vital signs

    Abnormal results of vital signs

    Measured: Minimum of 2 years post CT103A infusion

  4. Phase 1: Physical examination

    Abnormal results of physical examination

    Measured: Minimum of 2 years post CT103A infusion

  5. 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

    Measured: 3 months post CT103A infusion

Secondary outcomes (14)

  1. Overall response rate (ORR) evaluated by the investigators

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

    Measured: 3 months post CT103A infusion

  2. Overall Survival (OS)

    Time from CT103A infusion to time of death due to any cause

    Measured: Minimum of 2 years post CT103A infusion

  3. Duration of Response (DOR)

    Time from first response evaluated by an IRC or investigators to disease progression or death from any cause

    Measured: Minimum of 2 years post CT103A infusion

  4. Progression-free Survival (PFS)

    Time from CT103A infusion to first documentation of progressive disease (PD), or death due to any cause, whichever occurs first

    Measured: Minimum of 2 years post CT103A infusion

  5. Time to Response (TTR)

    Time from CT103A infusion to first documentation of response evaluated by an IRC or investigators

    Measured: Minimum of 2 years post CT103A infusion

  6. Laboratoty tests

    Abnormal results of laboratoty tests

    Measured: Minimum of 2 years post CT103A infusion

  7. Vital signs

    Abnormal results of vital signs

    Measured: Minimum of 2 years post CT103A infusion

  8. Physical examination

    Abnormal results of physical examination

    Measured: Minimum of 2 years post CT103A infusion

  9. Minimal Residual Disease (MRD)

    Proportion of subjects who achieved MRD negative

    Measured: Minimum of 2 years post CT103A infusion

  10. Pharmacokinetics - Cmax

    The maximum transgene level at Tmax

    Measured: Minimum of 2 years post CT103A infusion

  11. Pharmacokinetics - Tmax

    Time to peak transgene level

    Measured: Minimum of 2 years post CT103A infusion

  12. Pharmacokinetics - AUC0-28days

    Area under the curve of CAR T cells from time zero to Day 28

    Measured: Minimum of 2 years post CT103A infusion

  13. Pharmacokinetics - AUC0-90days

    Area under the curve of CAR T cells from time zero to Day 90

    Measured: Minimum of 2 years post CT103A infusion

  14. soluble BCMA levels

    soluble BCMA levels in peripheral blood of subjects

    Measured: Minimum of 2 years post CT103A infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2021
  2. Study start1 Apr 2020
  3. Primary completionOct 2022 (estimated)
  4. Study completionJun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
132 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05066646
Sponsor's protocol ID
XL-LCYJ-0007
Acronym
FUMANBA-1
Status last verified
Sep 2021
First submitted
22 Sep 2021
Last updated
23 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37658205

  • 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.

    PubMed 37192741

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CT103A in people with Multiple Myeloma, run by Nanjing IASO Biotechnology Co., Ltd. at 14 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Songbai Cai (+86 025-58287610, simon@iasobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Incidence and Severity of Adverse Events (time frame: Minimum of 2 years post CT103A infusion). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05066646, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2021.

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