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Acute Lymphocytic LeukemiaPhase 1NCT03840317

Senl_1904A and Senl_1904B Chimeric Antigen Receptor （CAR） T-Cell in the Treatment of r/ r Acute B Lymphocytic Leukemia

A Phase 1 study testing Autologous CD19-targeting CAR T cells in people with Acute Lymphocytic Leukemia, run by Hebei Senlang Biotechnology Inc., Ltd. 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is an open, two arms, mask phase I clinical study to evaluate efficacy and safety of two different chimeric antigen receptor T cell immunotherapies (Senl_1904A and Senl_1904B) targeting cluster of differentiation antigen 19 （CD19） in the treatment of Acute lymphocytic Leukemia. Read more about this study

Who is it for?
Ages 3 to 65 years
Conditions the study is for
Acute Lymphocytic Leukemia
What is being tested?
Autologous CD19-targeting CAR T cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
2 Jan 2019to 31 Jan 2022
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 3 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Subjects with acute lymphocytic leukemia who voluntarily signed informed consent and met the following criteria:
  • Patients with relapsed and refractory acute B lymphocytic leukemia with any of the following:
  • Recurrence after remission by chemotherapy or autologous stem cell transplantation (including B-ALL patients with bone marrow recurrence of morphology and recurrence of micro-residual );
  • Primary B-ALL patients who cannot be completely relieved by repeated chemotherapy twice or more;
  • High-risk initial onset B-ALL patients not completely relieved after 1 or 2 times of chemotherapy but not suitable for re-chemotherapy ;
  • Tumor cells confirmed CD19 positive by Flow cytometry (FCM)
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  • For B-ALL patients with simple extramedullary recurrence , there must be at least one evaluable lesion;
  • Eastern Cooperative Oncology Group (ECOG) ≤ 2 points;
  • Age 3 - 65 years old;
  • The bone marrow tumor load value (morphology) > 5% at the time of enrollment;
  • The main organ function needs to meet the above conditions: cardiac ultrasound or multiple gated image acquisition analysis （MUGA） scan indicate the cardiac ejection fraction is ≥50% , and there is no obvious abnormality in the electrocardiogram; blood oxygen saturation≥90%; creatinine ≤1.6mg/dl; alanine amino transferase (ALT) and Aspartate transaminase (AST)≤3 times normal range, total bilirubin（TBil） ≤2.0mg/dl;
  • The expected survival time is longer than 3 months;
  • The pregnancy test for women of childbearing age must be negative; Subjects with a pregnancy plan must agree to take contraception before the enrollment study and after the study lasts for one year; if the subject is pregnant or suspects of pregnancy, the investigator should be notified immediately
  • An informed consent form is required.

Who cannot join

  • 1) Severe cardiac insufficiency; 2) A history of severe pulmonary dysfunction; 3) Combined with other malignant tumors; 4) Combined with serious infections or persistent infection and cannot be effectively controlled; 5) Combined with metabolic diseases (except DM); 6) Combined with severe autoimmune diseases or congenital immune defects; 7) Active hepatitis (HBV DNA or HCVRNA detection positive); 8) HIV infection or syphilis infection; 9) A history of severe allergies to biological products (including antibiotics); 10) Subjects with recurrence after allogeneic hematopoietic stem cell transplantation 11) chronic lymphocytic leukemia（CLL） /myeloproliferative neoplasms with acute lymphoid transformation or CLL transform to ALL ; 12) Any drug that has been used against graft-versus-host disease（GVHD） for nearly 4 weeks, such as methotrexate or other chemotherapeutic drugs, mycophenolate mofetil, immunosuppressive antibodies, etc.; 13) Subjects who have received any anti-CD19 medication; 14) Subjects who have used anti-cluster of differentiation antigen 20（CD20） drugs (such as rituximab) for nearly 4 weeks; 15) Subjects who have participated in any other clinical drug trials in the past six months; 16) Female patients who are pregnant and lactating, or have a pregnancy plan within 12 months; 17) The investigator believes that it may increase the risk of the subject or interfere with the outcome of the test (with a history of severe mental illness, drug abuse and history of addiction).
  • Exit criteria：
  • The subjects request to withdraw from the study before CAR-T infusion
  • The subjects seriously violate the protocol
  • Before CAR-T infusion, the following indicators are still abnormal after treatment:
  • Platelets <20x10^9/L, hemoglobin ≤80g/L, peripheral finger oxygen <90%, AST / ALT / alkaline phosphatase（ALP） ≥ 2.5 upper limits of normal（ULN）, total bilirubin ≥ 1.5ULN , creatinine clearance rate <70ml / min, left ventricular ejection fraction <50%, the researcher judged that the test needs to be terminated early;
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  • The therapeutic dose of steroids was not stopped within 72 hours prior to CAR-T infusion and the investigator determined that the trial needs to be terminated . However, the following physiologically acceptable doses of steroids are permissible: hydrocortisone or equivalent <6-12 mg/m2/day ;
  • Not enough T cells for manufacture standard CAR-T cells
  • Other serious adverse events occurred
  • MRD become negative after preconditioning regiment

Trial locations and contacts

1 site in 1 country.

China1 site

  • Hebei Yanda Ludaopei Hospital

    Langfang, Hebei, 065000

Other trials in China

About this study

Official title: Randomized, Parallel-arm, Controlled Trial of Senl_1904A and Senl_1904B Autologous CAR-T Cell Injections in the Treatment of Relapsed and Refractory Acute B Lymphocytic Leukemia(r/r B-ALL)

This is an open, two arms, mask phase I clinical study to evaluate efficacy and safety of two different chimeric antigen receptor T cell immunotherapies (Senl_1904A and Senl_1904B) targeting cluster of differentiation antigen 19 （CD19） in the treatment of Acute lymphocytic Leukemia. A total of 20 patients are planned to be enrolled following up half a year.

Read the detailed description

The CARs consist of an anti-CD19 single-chain variable fragment（scFv） that was derived from the FMC63 mouse hybridoma, a portion of the human CD137（4-1BB） molecule, and the intracellular component of the human CD3ζ molecule. Autologous T cells will be gene engineered with the CAR gene using a lentivirus vector. Compared to Senl_1904A, Senl_1904B has a higher and more stable transfection efficiency and secretes lower levels of cytokines in functional assays, thus having the potential to significantly reduce the incidence of serious adverse events while ensuring the same complete response rate. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for one month after infusion for adverse reactions and efficacy.

Being tested
Autologous CD19-targeting CAR T cells
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

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

  • Autologous CD19-targeting CAR T cellsBiological

    Autologous CD19-targeting CAR T cells

Study groups in NCT03840317
Study groupRoleWhat they receive
Senl_1904A CD19 CAR-TExperimentalAutologous CD19-targeting CAR T cells, dosage 3*10^5/kg, intravenous injection once
Receives: Biological: Autologous CD19-targeting CAR T cells
Senl_1904B CD19 CAR-TExperimentalAutologous CD19-targeting CAR T cells,dosage 3*10^5/kg, intravenous injection once
Receives: Biological: Autologous CD19-targeting CAR T cells

What is being measured

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

  1. Tumor load

    Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.

    Measured: up to one month

Secondary outcomes (2)

  1. CAR T cell expansion

    The percentage of CAR-T cells (CAR+/CD3+ T cells) in the bone marrow samples, quantified by flow cytometry.

    Measured: up to one month

  2. CAR T cell persistence

    The method to detect CAR-T cell persistence is by determining the exact copies of CAR per ug DNA in BM through quantitative polymerase chain reaction（qPCR）

    Measured: up to one month

Timeline

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

  1. First posted15 Feb 2019
  2. Study start2 Jan 2019
  3. Primary completion1 Sep 2021 (estimated)
  4. Study completion31 Jan 2022 (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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03840317
Sponsor's protocol ID
Senl_1904A & Senl_1904B CAR-T
Status last verified
Jan 2021
First submitted
27 Jan 2019
Last updated
20 Jan 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ho JY, Wang L, Liu Y, Ba M, Yang J, Zhang X, Chen D, Lu P, Li J. Promoter usage regulating the surface density of CAR molecules may modulate the kinetics of CAR-T cells in vivo. Mol Ther Methods Clin Dev. 2021 Mar 13;21:237-246. doi: 10.1016/j.omtm.2021.03.007. eCollection 2021 Jun 11.

    PubMed 33869653

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Autologous CD19-targeting CAR T cells in people with Acute Lymphocytic Leukemia, run by Hebei Senlang Biotechnology Inc., Ltd. 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 14 inclusion and 10 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 20 Jan 2021. 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?

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?

Tumor load (time frame: up to one month). 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 NCT03840317, which also lists 1 linked publication.

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 20 Jan 2021.

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