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B-cell LymphomaPhase 1NCT04877080

CD19 and BCMA Targeted Fast Dual CAR-T for CD19+ Refractory/Relapsed B-NHL

A Phase 1 study testing Fast Dual CAR-T Injection in people with B-cell Lymphoma, run by 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a single arm, open-label, single-center prospective study to determine the safety and efficacy of Fast Dual CAR-T cells in patients diagnosed with CD19+ refractory/relapsed B cell non-Hodgkinlymphoma (R/R B-NHL). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
B-cell Lymphoma
What is being tested?
Fast Dual CAR-T Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
5 May 2021to 31 Dec 2023
Phase
Phase 1
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed: Diffuse Large B Cell Lymphoma (DLBCL), Transformation Follicular Lymphoma (TFL), Primary Mediastinal Large B Cell Lymphoma (PMBCL) and Mantle Cell Lymphoma (MCL), High-Grade B Cell Lymphoma (HGBL);
  • Refractory B-NHL: PD as the best response to normative first-line therapy (intolerance of first-line therapy is not included in this study) or SD as the best response to at least 4 courses of first-line therapy with duration no longer than 6 month from last therapy; or PD as the best response to the last therapy of second-line therapy and above,or SD as the best response to at least 2 courses of second-line therapy with duration no longer than 6 month from last therapy, or:
  • Relapsed B-NHL: Histopathology confirmed relapse after standard systemic and second-line therapy achieved CR, or histopathologically confirmed relapse within 1 year after autologous hematopoietic stem cell transplantation (Not limited by previous therapy);
  • Prior therapy must include anti-CD20 monoclonal antibody (unless investigator determines that tumor is CD20-negative) and an anthracycline;
  • For individual with TFL, must have chemotherapy and the conform the above definition of relapse or refractory after transformation;
  • According to the 2014 Lugano therapy response standard, there should be at least one measurable tumor focus: the longest diameter of nodular lesions> 1.5 cm, and the longest diameter of extranodal lesions> 1.0 cm;
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  • CD19 positive expression in tumor tissue biopsy;
  • Prior to apheresis, approved anti-B-NHL therapys such as systemic chemotherapy, systemic radiotherapy and immunotherapy have been completed for at least 2 weeks;
  • Eastern cooperative oncology group (ECOG) performance status of 0 to 1;
  • Life expectancy ≥12 weeks;
  • Absolute neutrophil count (ANC)≥ 1×10^9/L;
  • Platelet count≥50×10^9/L;
  • Absolute lymphocyte count (ALC)≥1×10^8/L;
  • Adequate organ function defined as:
  • Serum ALT/AST ≤2.5 ULN;
  • Creatinine clearance (as estimated by Cockcroft Gault) ≥60 mL/min;
  • PT and APTT≤1.5 ULN
  • Total bilirubin ≤1.5 ULN;
  • Cardiac ejection fraction ≥50%, no pericardial effusion, no clinically significant ECG findings;
  • Baseline oxygen saturation >92% on room air;
  • Sufficient venous access for leukapheresis collection, and no other contraindications to leukapheresis;
  • Female of childbearing age must agree to take effective contraceptive measures at least 1 year after infusion; Male with fertile partners must agree to use effective barrier contraceptive methods at least 1 year after infusion;
  • Understand and voluntarily sign the informed consent form.

Who cannot join

  • Diagnosis of other malignancy (except for cured non-melanoma skin cancer, cervical carcinoma in situ, superficial bladder cancer, ductal carcinoma in situ, or other malignancies that have completely responsed for more than 5 years);
  • Severe mental disorders;
  • History of hereditary diseases, including but not limited to: Fanconi anemia, Shut-Dai syndrome, Costman syndrome or any other known bone marrow failure syndrome;
  • History of allogeneic stem cell transplantation;
  • Grade III-IV heart failure or myocardial infarction, angioplasty or stent placement, unstableangina pectoris, or other clinically prominent heart disease within one year before enrollment.
  • Have any indwelling catheter or drainage tube (such as percutaneous nephrostomy tube, indwelling catheter, bile drainage tube or pleura / peritoneum / pericardial catheter), the use of dedicated central venous catheter is allowed;
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  • Subjects with CNS lymphoma, cerebrospinal fluid malignant cells or brain metastases;
  • History or presence of CNS disorder, including but not limited to: seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement;
  • Positive for any of the following etiological tests: HIV, HBV, HCV, TPPA;
  • Presence of fungal, bacterial, viral, or other infection that is uncontrolled;
  • Allergic subjects or subjects with severe allergic reactions to cyclophosphamide or fludarabine;
  • History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years;
  • History or diagnosis of pulmonary fibrosis;
  • Have received gene therapy or any other CAR-T treatment;
  • Have received any other drugs targeting CD19;
  • Subjects who received other clinical trial therapy within 4 weeks before participating in this trial, or the informed consent form was signed within the 5 half-life of the last administration in the other clinical trial (take longer time as standard);
  • Poor adherence due to physical, family, social, geographic, and other factors, who cannot follow the research plan and follow-up plan;
  • Subjects with comorbidities that require systemic corticosteroid therapy (≥5 mg/day of prednisone or an equivalent dose of other corticosteroids) or other immunosuppressive drugs within 6 months after study therapy according to the discretion of investigator;
  • Lactating women who are reluctant to stop breastfeeding;
  • Any other conditions defined by researcher that is inappropriate for the subject to be enrolled.

About this study

Official title: Exploratory Study to Evaluate Efficacy and Safety of Fast Dual CAR-T Injection in CD19+ Refractory or Relapsed B Cell Non-Hodgkinlymphoma

This is a single arm, open-label, single-center prospective study to determine the safety and efficacy of Fast Dual CAR-T cells in patients diagnosed with CD19+ refractory/relapsed B cell non-Hodgkinlymphoma (R/R B-NHL).

Read the detailed description

The main aim of the study is to determine the safety and efficacy of Fast Dual CAR-T in R/R B-NHL. Fast Dual CAR-T is an autologous dual chimeric antigen receptor T-cell (CAR-T) therapy that targets CD19 and B-cell maturation antigen (BCMA). The study will include 15 subjects to receive Fast Dual CAR-T single infusion.

Conditions
B-cell Lymphoma
Being tested
Fast Dual CAR-T Injection
Keywords
Fast, CAR-T, CD19, B-NHL
Medical subject headings
Lymphoma, B-Cell, Fasting

What participants receive

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

  • Fast Dual CAR-T InjectionBiological

    Fast Dual CAR-T injection is a autologous dual CAR-T targeted CD19 and BCMA. A single infusion of CART cells will be administered intravenously.

Study groups in NCT04877080
Study groupRoleWhat they receive
Fast Dual CAR-T treatmentExperimentalCD19+ R/R B-NHL patients be treated with a single dose of Fast Dual CAR-T cells. Total dose of (1-5)*10E5/kg cells will be administered at Day 0.
Receives: Biological: Fast Dual CAR-T Injection

What is being measured

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

  1. Incidence of AE after Fast Dual CAR-T infusion

    Incidence of adverse events after Fast Dual CAR-T infusion

    Measured: up to 24 weeks after Fast Dual CAR-T infusion

Secondary outcomes (7)

  1. ORR rate

    Overall response rate (ORR=CR+CRi) after Fast Dual CAR-T infusion

    Measured: 12 weeks, 24 weeks after Fast Dual CAR-T infusion

  2. PFS

    Progression free survival (PFS) after Fast Dual CAR-T infusion

    Measured: 12 weeks, 24 weeks after Fast Dual CAR-T infusion

  3. OS

    overall survival (OS) after Fast Dual CAR-T infusion

    Measured: 12 weeks, 24 weeks after Fast Dual CAR-T infusion

  4. Change of CAR Copies

    CAR Copies measured by qPCR after Fast Dual CAR-T infusion

    Measured: Days 4, 7, 10, 14 and weeks 4, 8, 12, 18, 24 after Fast Dual CAR-T infusion

  5. Change of CAR-T cell counts

    CAR-T cell counts measured by Flow cytometry after Fast Dual CAR-T infusion

    Measured: Days 4, 7, 10, 14 and weeks 4, 8, 12, 18, 24 after Fast Dual CAR-T infusion

  6. Changes in the concentration of cytokine IL-1, IL-2, IL-6, IL-10, TNF-α and IFN-γ.

    Cytokines in serum measured by ELISA after Fast Dual CAR-T infusion

    Measured: Days 4, 7, 10, 14 and 28 after Fast Dual CAR-T infusion

  7. Change of RCL in blood

    Replication competent lentivirus (RCL) in blood after Fast Dual CAR-T infusion

    Measured: Weeks 4, 12, 24 after Fast Dual CAR-T infusion

Timeline

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

  1. First posted7 May 2021
  2. Study start5 May 2021 (estimated)
  3. Primary completion30 Jun 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Why it stopped: The PI decides to withdraw the research.

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04877080
Sponsor's protocol ID
211
Status last verified
Feb 2023
First submitted
13 Apr 2021
Last updated
10 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Fast Dual CAR-T Injection in people with B-cell Lymphoma, run by 920th Hospital of Joint Logistics Support Force of People's Liberation Army of 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 23 inclusion and 20 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: withdrawn, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

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 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.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of AE after Fast Dual CAR-T infusion (time frame: up to 24 weeks after Fast Dual CAR-T infusion). 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 NCT04877080.

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 10 Feb 2023.

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