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Relapsed/Refractory Hematological MalignanciesPhase 1NCT05528887

Study of CAR-T Cell Therapy in the Treatment of Relapsed/Refractory Hematological Malignancies

A Phase 1 study testing Autologous CAR-T cells, Fludarabine and Cyclophosphamide in people with Relapsed/Refractory Hematological Malignancies and Lymphoma, run by The Affiliated People's Hospital of Ningbo University at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

The primary purpose of this study is to determine the safety and efficacy of novel autologous CAR-T cells in patients with relapsed/refractory hematological malignancies. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Autologous CAR-T cells, Fludarabine and Cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
16 Sep 2021to Jun 2026
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

  • Histological diagnosis of hematological malignancies (such as lymphoma, myeloma, leukemia) refractory to, or relapsing after standard therapy.
  • Positive expression of specific antigens.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0~2.
  • Adequate organ functions:
  • Serum bilirubin ≤ 35 μmol/L;
  • Serum aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 2;
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  • Serum creatinine (Cr) ≤ 2 × upper limit of normal (ULN);
  • Brain natriuretic peptide (BNP)<80 pg/mL.
  • Subjects must be able to understand the protocol and be willing to enroll the study, sign the informed consent, and be able to comply with the study and follow-up procedures.

Who cannot join

  • History of allergy to any of the drugs involved in the protocol.
  • History of cardiac diseases:
  • Left ventricular ejection fraction (LVEF) < 50%;
  • Class III or IV heart failure as defined by the New York Heart Association (NYHA).
  • History of another malignancy tumor.
  • Active hepatitis C (HCV), hepatitis B (HBV), human immunodeficiency virus (HIV), or syphilis infection.
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  • Patients with any contraindications to allogeneic hematopoietic stem cell transplantation.
  • Uncontrolled fungal, bacterial, viral, or other infection.
  • Female subjects who are pregnant or lactating.

Trial locations and contacts

1 site in 1 country.

Ying Lu contact

86-13486090834

814871416@qq.com

Dong Chen contact

86-13805888089

13805888089@163.com

China1 site, 1 recruiting

  • The Affiliated People's Hospital of Ningbo University

    Ningbo, Zhejiang, 315101

    Dong Chen, +8613805888089, 13805888089@163.com

    Recruiting

Other trials in China

About this study

Official title: Safety and Efficacy Study of Chimeric Antigen Receptor T (CAR-T) Cells in the Treatment of Relapsed/Refractory Hematological Malignancies

The primary purpose of this study is to determine the safety and efficacy of novel autologous CAR-T cells in patients with relapsed/refractory hematological malignancies.

Read the detailed description

CAR-T cells targeted CD19 have demonstrated unprecedented successes. Besides CD19, many other molecules such as CD123, BCMA, and CD7 may be potential in developing the corresponding CAR-T cells to treat patients with hematopoietic and lymphoid malignancies. UTC Therapeutics Inc. have developed an efficient platform for constructing CAR-T cells that can remodel of tumor microenvironment and enhance the anti-tumor immune response and persistence of CAR-T cells. In this study, all eligible subjects will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by investigational treatment, CAR-T cells. Safety and efficacy of the CAR-T cells will be assessed.

Being tested
Autologous CAR-T cells, Fludarabine, Cyclophosphamide
Keywords
CD19 CAR-T, BCMA CAR-T, CD7 CAR-T, CD123 CAR-T
Medical subject headings
Hematologic Neoplasms, Lymphoma, Neoplasms, Plasma Cell, Leukemia

What participants receive

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

  • Autologous CAR-T cellsBiological

    D0: CAR-T cells will be infused intravenously.

  • FludarabineDrug

    Also called Fludara

    D-5 to D-3: Fludarabine (30 mg/m^2/day) will be administered intravenously for 3 days.

  • CyclophosphamideDrug

    Also called Cytoxan

    D-5 to D-3: Cyclophosphamide (500 mg/m^2/day) will be administered intravenously for 3 days.

Study groups in NCT05528887
Study groupRoleWhat they receive
Autologous CAR-T cellsExperimentalA conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, CAR-T cells. CAR-T cells targeted CD19/BCMA/CD123/CD7 are autologous genetically modified T cells.
Receives: Biological: Autologous CAR-T cells; Drug: Fludarabine; Drug: Cyclophosphamide

What is being measured

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

  1. TEAEs

    Incidence and severity of Treatment Emergent Adverse Event.

    Measured: 4 weeks

  2. TRAEs

    Incidence and severity of Treatment Related Adverse Events.

    Measured: 4 weeks

  3. AESIs

    Incidence and severity of AEs of Special Interest.

    Measured: 4 weeks

Secondary outcomes (3)

  1. Objective Response Rate (ORR) (PR+CR)

    The proportion of patients with complete response(CR) or partial response(PR)

    Measured: 12 months

  2. Progression-Free Survival (PFS)

    PFS was defined as the time from CAR-T infusion to the date of disease progression or death from any cause.

    Participants not meeting the criteria for progression by the analysis data cutoff date were censored at their last evaluable disease assessment date.

    Measured: 12 months

  3. Overall survival (OS)

    OS was defined as the time from CAR-T infusion to the date of death. Participants who did not die by the analysis data cutoff date were censored at their last contact date.

    Measured: 12 months

Timeline

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

  1. First posted6 Sep 2022
  2. Study start16 Sep 2021
  3. Primary completionJun 2024 (estimated)
  4. Study completionJun 2026 (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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05528887
Sponsor's protocol ID
2021-037
Status last verified
Sep 2022
First submitted
1 Sep 2022
Last updated
6 Sep 2022
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 Autologous CAR-T cells, Fludarabine and Cyclophosphamide in people with Relapsed/Refractory Hematological Malignancies and Lymphoma, run by The Affiliated People's Hospital of Ningbo University at 1 site 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 9 inclusion and 9 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 6 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 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?

Results are not available in the source record.

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

Contact Ying Lu (86-13486090834, 814871416@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

TEAEs (time frame: 4 weeks). The study lists 3 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 NCT05528887.

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 6 Sep 2022.

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