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B-cell MalignancyPhase 1NCT03559439

CD19-targeting CAR T Cells in Relapsed or Refractory CD19 Positive B-cell Malignancies

A Phase 1 study testing CD19 CAR T in people with B-cell Malignancy and B-cell Lymphoma, run by Shanghai Tong Ren Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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 a single center, single arm, open-label phase 1 study to determine the safety and efficacy of autologous T cells expressing CD19 chimeric antigen receptors in adults with CD19+ B cell malignancies. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
CD19 CAR T
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteChina
Study dates
24 Apr 2018to 31 Dec 2021
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

  • CD19+ relapsed or refractory B cell malignancies:
  • Relapsed or refractory B acute lymphocytic leukemia.
  • Relapse was defined as presence of > 5% blasts at screening, or second or subsequent bone marrow relapse, or any bone marrow relapse after allogeneic stem cell transplant and must be ≥ 6 months from stem cell transplant at the time of infusion.
  • Refractory was defined by not achieving an initial complete response after 2 cycles of a standard chemotherapy regimen . Patients who were refractory to subsequent chemotherapy regimens after an initial remission were considered chemorefractory
  • Patients with Ph+ acute lymphocytic leukemia were eligible if they are intolerant to or have not achieved a remission after two lines of tyrosine kinase inhibitor therapy, or if tyrosine kinase inhibitor therapy is contraindicated, or ineligible for allogeneic stem cell transplant because of:
  • Comorbid disease
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  • Other contraindications to allogeneic stem cell transplant conditioning regimen
  • Lack of suitable donor
  • Prior hematopoietic stem cell transplant
  • Declined allogeneichematopoietic stem cell transplant as a therapeutic option
  • Relapsed or refractory non-Hodgkin's lymphoma
  • Histopathological CD19+.
  • No response to last line of therapy i. partial response as best response to most recent therapy regimen ii. partial response as best response to most recent therapy with duration no longer than 6 month from last dose of therapy
  • Refractory post-Autologous stem cell transplant i. Disease progression or relapsed less than or equal to 12 months of Autologous stem cell transplant (must have biopsy proven recurrence in relapsed subjects) ii. If salvage therapy is given post-Autologous stem cell transplant, the subject must have had no response to or relapsed after the last line of therapy
  • Subjects must have received adequate prior therapy including at a minimum: anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20-negative and an anthracycline containing chemotherapy regimen for subjects with transformed follicular lymphoma must have received prior chemotherapy for follicular lymphoma and subsequently have chemorefractory disease after transformation to Diffuse large B-cell lymphoma
  • At least one measurable lesion per revised IWG Response Criteria
  • 18-75 years old
  • Expected survival ≥ 12 weeks
  • Adequate renal, hepatic, pulmonary and cardiac function defined as:
  • Creatinine clearance (as estimated by Cockcroft Gault) > 60 mL/min
  • Serum ALT/AST <2.5 ULN
  • Total bilirubin <1.5 mg/dl, except in subjects with Gilbert's syndrome
  • Cardiac ejection fraction >50%, no evidence of pericardial effusion as determined by an echocardiogram, and no clinically significant pleural effusion
  • Baseline oxygen saturation >92% on room air
  • Eastern cooperative oncology group (ECOG) performance status of 0 - 2
  • Pregnant or lactating women must have a negative pregnancy test before infusion, and agree to take effective contraception during the trial
  • Apheresis product received and accepted
  • Written informed consent

Who cannot join

  • Isolated extra-medullary relapse leukemia
  • Other malignancies
  • Concomitant genetic syndrome, with the exception of Down Syndrome
  • Burkitt's lymphoma/leukemia
  • Treatment with any prior gene therapy product, anti-CD19/anti-CD3 therapy, or any other anti-CD19 therapy
  • Active hepatitis B, C, or any uncontrolled infection
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  • Grade 2 to 4 Graft versus Host Disease (GVHD)
  • Medications or treatments that were to be excluded:
  • Corticosteroids within 72 hours of infusion, with the exception of physiologic replacement
  • Allogeneic cellular therapy, such as donor lymphocyte infusion within 6 weeks prior to infusion
  • Graft versus Host Disease therapies
  • Chemotherapy stopped prior to lymphodepletion based on clearance
  • central nervous system prophylaxis treatment
  • Active central nervous system disease (central nervous system 2 disease [Cerebral spinal fluid containing blasts, but < 5 WBCs/microliter] patients were eligible)
  • Any condition that investigator considered may increase the risk of the subjects or interfere with the trial results

Trial locations and contacts

1 site in 1 country.

Ligen Liu contact

18017337037

llg3532@shtrhospital.com

China1 site, 1 recruiting

  • Shanghai Tong Ren hospital

    Shanghai

    Ligen Liu, 18017337037, llg3532@shtrhospital.com

    Recruiting

Other trials in China

About this study

Official title: CD19-targeting CAR T Cell Therapy in the Treatment of Relapsed or Refractory CD19 Positive B-cell Malignancies

This is a single center, single arm, open-label phase 1 study to determine the safety and efficacy of autologous T cells expressing CD19 chimeric antigen receptors in adults with CD19+ B cell malignancies.

Read the detailed description

This is a single-center, Open Label phase I clinical trial, 9 subjects planned to be enrolled. The subjects will be divided into low-dose group, medium-dose group and high-dose group.Dose CAR+ cells/kg Low 1×105 Medium 2×106 High 6×106

Being tested
CD19 CAR T
Medical subject headings
Lymphoma, B-Cell, Burkitt Lymphoma

What participants receive

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

  • CD19 CAR TBiological

    CD19 CAR T cells transduced with a lentiviral vector to express anti-CD19 scFv CD3z:CD28 administered by IV infusion. Subjects will receive 0.1-10 x 10^6 transduced CAR T cells as a split dose over three days as follows:Day 1, 10% fraction, Day 2, 30% fraction, Day 3, 60% fraction.

Study groups in NCT03559439
Study groupRoleWhat they receive
CD19 CAR TExperimentalCD19 CAR T cells transduced with a lentiviral vector to express anti-CD19 scFv CD3z:CD28 administered by IV infusion.
Receives: Biological: CD19 CAR T

What is being measured

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

  1. Frequency and severity of toxicities and adverse events

    To assess the frequency and severity of toxicities and adverse events according to NCI CTC v4.0

    Measured: 24 weeks

Secondary outcomes (2)

  1. overall response rate

    To assess the overall response rate after CD19 CAR T infusion in R/R B cell malignancies

    Measured: 24 week

  2. overall survival

    To assess the overall survival in patients with R/R B cell malignancies

    Measured: 24 week

Timeline

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

  1. First posted18 Jun 2018
  2. Study start24 Apr 2018
  3. Primary completion30 Nov 2021 (estimated)
  4. Study completion31 Dec 2021 (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
9 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03559439
Sponsor's protocol ID
PTA001
Status last verified
Nov 2020
First submitted
30 May 2018
Last updated
5 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CD19 CAR T in people with B-cell Malignancy and B-cell Lymphoma, run by Shanghai Tong Ren Hospital 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 28 inclusion and 15 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 5 Nov 2020. 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 Ligen Liu (18017337037, llg3532@shtrhospital.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency and severity of toxicities and adverse events (time frame: 24 weeks). 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 NCT03559439.

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 5 Nov 2020.

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