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AzTrials

B Acute Lymphoblastic LeukemiaEarly Phase 1NCT04184414

The Clinical Application of Chimeric Antigen Receptor T Cells in the Treatment of CD19 Positive Recurrent Refractory B Cell-derived Hematological Malignancies

A Early Phase 1 study testing CD19-CART in people with B Acute Lymphoblastic Leukemia and Mantle Cell Lymphoma, run by PersonGen BioTherapeutics (Suzhou) Co., 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 The sponsor has not verified this record for over two years, so it may be out of date.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

CD19 is expressed in most B malignant tumors, especially in the former B cells ALL. This makes CD19 a natural target of immunotherapy. In terms of safety, the lack of B cells caused by CD19 targeted therapy will not cause life-threatening side effects (of course, Ig supplementation is necessary in the long-term B cell… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
CD19-CART
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
9 Jan 2018to 1 Jan 2020
Phase
Early 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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. At the time of initial diagnosis, the age is 18-70 years old, regardless of gender or race
  • 2. Morphological analysis showed that the load of lymphoma was ≥ 5%
  • 3. Estimated survival time > 12 weeks
  • 4. The main investigator and the attending physician of the patient think that there is no other feasible and effective alternative treatment, such as hematopoietic stem cell transplantation
  • 5. Relapsed / refractory B-cell acute lymphocytic leukemia (all): A. objective remission rate (or) of grade 2 or higher bone marrow recurrence B. bone marrow relapse after allogeneic stem cell transplantation (SCT), SCT treatment is more than 6 months and in or state before cart-19 reinfusion C. refractory patients (CR status is not reached after 2 rounds of standard chemotherapy (CR refers to the load of myeloma detected by morphology < 5%)) D. Philadelphia chromosome positive (Ph +) and tyrosine kinase inhibitor (TKI) treatment failed twice or TKI failed to maintain or E. treatment with allogeneic SCT
  • 6. For patients with relapse, CD19 was detected in bone marrow or peripheral blood by flow cytometry within 3 months before admission
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  • 7. CD19 expression on lymphoma cells: immunohistochemistry > 15% or flow cytometry > 30%
  • 8. The main organ functions are sound, including: A. renal function: radioisotope glomerular filtration rate > 60 ml / min / 1.73 m2, or serum creatinine clearance rate in line with relevant age / gender standards B. alanine transferase (ALT) < 5 times the normal maximum value of the same age C. bilirubin < 2.0 mg / dl D. to achieve the minimum pulmonary function: ≤ grade I dyspnea and indoor blood oxygen concentration > 91% E. echocardiography or multi gated angiography (MUGA) showed that the left ventricular short axis shortening rate (LVSF) was ≥ 28%, or left ventricular ejection fraction (LVEF) was ≥ 45%
  • 9. Karnofsky score (age ≥ 16 years old) ≥ 50 or zubrod-ecog-who score ≤ 2
  • 10. Sign written informed consent and obtain consent before any research is carried out
  • 11. When the above other conditions are met, the cell culture factory must receive fresh blood samples from patients. In the case of monocultured cells, they can only be accepted by the cell culture factory if the relevant tests are qualified

Who cannot join

  • 1. Recurrence of isolated extramedullary diseases
  • 2. The patient is accompanied by the following genetic syndrome: Fanconi syndrome, Kostmann syndrome, Shwachman syndrome or any known myelofailure syndrome. Patients with Down syndrome are not included in the exclusion criteria
  • 3. Patients with Burkitt's lymphoma / leukemia (i.e. patients with mature B cell all, B cell surface immunoglobulin positive (SIG +) and light chain kappa or lambda type, morphology Fab L3 or myc ectopic expression)
  • 4. Patients with previous history of malignant tumor but cured skin or cervical carcinoma in situ and patients with inactive tumor are not included in the exclusion criteria
  • 5. Previous use of gene therapy
  • 6. Previous use of anti-CD19 / CD3 combination therapy or any other anti-CD19 treatment
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  • 7. Hepatitis B or C or HBV / HCV or other uncontrolled infection at the time of screening
  • 8. Screening with HIV infection
  • 9. Acute or chronic graft-versus-host reaction (GVHD) of level 2-4
  • 10. Use the following drugs: A. steroid: it is forbidden to use within 72 hours before cart-19 reinfusion, but physiological steroid treatment dose (< 6 - 12 mg / m2 / day) or equivalent hydrocortisone can be used B. allogeneic cell therapy: no donor lymphocyte infusion (DLI) is allowed within 6 weeks before cart-19 reinfusion C. GVHD treatment: any GVHD treatment (such as calmodulinase inhibitor, methotrexate, mycophenolate ester, steroid (see above), rapamycin, thalidomide or immunosuppressive antibody (such as anti-CD20 / TNF / IL6 / IL6R)) must be stopped within 4 weeks before cart-19 infusion D. chemotherapy: I. The following drugs should be stopped for at least one week before cart-19 infusion, and it is better not to accompany or follow the lymphocyte elimination chemotherapy plan: hydroxyurea, vincristine, 6-mercaptopurine, 6-thioguanine, methotrexate < 25 mg / m2, cytarabine < 10 mg / m2 / day, asparaginase; II. The following drugs should be stopped for at least four weeks before cart-19 infusion: remedial chemotherapy (such as chlorine method) Lapin, cytarabine > 100 mg / m2, anthracycline drugs, cyclophosphamide), lymphocyte clearance chemotherapy drugs are not included in the exclusion criteria E. central nervous system (CNS) disease prevention: CNS prevention and treatment should be stopped at least one week before cart-19 reinfusion (such as MTX injection into spinal cord)
  • 11. For CNS infiltration of malignant tumors, refer to the guidelines of national comprehensive cancer network (NCCN) cns-3. Note: the patients with CNS diseases who have been effectively treated are not included in the exclusion criteria. The patients cannot participate in the drug trial within 30 days before screening
  • 12. Pregnant or lactating women: 48 hours before reinfusion, the female test participants must carry out serum or urine pregnancy test, and the test result is positive
  • 13. Women of childbearing age and all men did not take effective contraceptive methods within one year after cart-19 transfusion

Trial locations and contacts

1 site in 1 country.

Bingzong Li, M.D. contact

+8613776054037

lbzwz0907@hotmail.com

China1 site, 1 recruiting

  • Hematology Department of the Second Affiliated Hospital of Suzhou University

    Suzhou, Jiangsu

    Bingzong Li, M.D., +8613776054037, lbzwz0907@hotmail.com

    Recruiting

Other trials in China

About this study

Official title: CD19-CART Cells in the Treatment of CD19+ r/r B Cell-derived Hematological Malignancies

CD19 is expressed in most B malignant tumors, especially in the former B cells ALL. This makes CD19 a natural target of immunotherapy. In terms of safety, the lack of B cells caused by CD19 targeted therapy will not cause life-threatening side effects (of course, Ig supplementation is necessary in the long-term B cell inhibition therapy). Moreover, the number of B cells can be restored after removing anti-CD19 treatment measures (such as anti-CD19 CART cells). In addition, CD19 has been chosen as the target of B-ALL therapy for the following reasons: ① as the BCR signal "amplifier", CD19 plays a role in PAX-5-mediated tumor formation; ② by activating MYC (as the oncogene controlled by PAX-5, C-MYC plays a key role in promoting the malignant proliferation of B cells), CD19 can cause B-ALL formation. Based on the above reasons, CD19 has become an ideal target in the treatment of B-cell cancer.

Being tested
CD19-CART
Medical subject headings
Burkitt Lymphoma, Lymphoma, Mantle-Cell, Lymphoma, Follicular

What participants receive

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

  • CD19-CARTDrug

    Also called Targeting hcd19 chimeric antigen receptor

    1-10x106 / kg CD19 CART cells

Study groups in NCT04184414
Study groupRoleWhat they receive
CART cellsExperimentaldosage：Once dose，1.0*10^6cells/kg CART cells Administration mode:Intravenous infusion
Receives: Drug: CD19-CART

What is being measured

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

  1. CR

    Complete response rate (CR)

    Measured: 12 weeks after infusion of the study drug

Secondary outcomes (2)

  1. PR

    Partial remission rate

    Measured: 12 weeks after infusion of the study drug

  2. 2-year disease-free survival rate 2-year disease-free survival rate

    2-year disease-free survival rate

    Measured: 12 weeks after infusion of the study drug

Timeline

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

  1. First posted3 Dec 2019
  2. Study start9 Jan 2018
  3. Primary completion1 Jan 2020 (estimated)
  4. Study completion1 Jan 2020 (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
Early 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
NCT04184414
Sponsor's protocol ID
PA-P19-001
Status last verified
Dec 2019
First submitted
4 Nov 2019
Last updated
3 Dec 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing CD19-CART in people with B Acute Lymphoblastic Leukemia and Mantle Cell Lymphoma, run by PersonGen BioTherapeutics (Suzhou) Co., 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 11 inclusion and 13 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 3 Dec 2019. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 Bingzong Li, M.D. (+8613776054037, lbzwz0907@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CR (time frame: 12 weeks after infusion of the study drug). 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 NCT04184414.

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 3 Dec 2019.

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