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Relapsed or Refractory B-cell Non-Hodgkin's LymphomaPhase 1/2NCT03664635

MB-CART20.1 Lymphoma

A Phase 1/2 study testing MB-CART20.1 in people with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma and Non-Hodgkin's Lymphoma, run by Miltenyi Biomedicine GmbH at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This trial is a phase I/II trial to assess safety, dose finding and feasibility of ex vivo generated MB-CART20.1 cells in patients with relapsed or refractory CD20 positive B-NHL. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MB-CART20.1
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesGermany
Study dates
25 Sep 2018to 17 Sep 2024
Phase
Phase 1/2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Refractory/relapsed CD20+ B-NHL (including malignant transformation like Richter's transformation) with no curative treatment option.
  • At least 18 years of age
  • Estimated life expectancy of more than 3 months
  • ECOG performance status (Eastern cooperative oncology group) of 0-2
  • Negative serological HBV (Hepatitis B virus) test, negative testing of HCVAb (Hepatitis C virus Antibody), negative HIV1/2 (Human immunodeficiency virus 1/2 ) test within 6 weeks prior to enrollment
  • No childbearing potential or negative pregnancy test at screening and before chemotherapy in women with childbearing potential.
  • Signed and dated informed consent before conduct of any trial-specific procedure

Who cannot join

  • Participation in another interventional trial that could interact with this trial
  • Any evidence 0f CNS (Central nervous system) involvement
  • Known history or presence of clinically relevant CNS pathology
  • Patients with history of primary immunodeficiency,
  • Patients with any history of auto-immune induced condition such as those caused by checkpoint inhibitors, MEK inhibitors or BRAF inhibitors, for example pituitary hypophysitis must be excluded
  • Patients with Chronic Lymphocytic Leukemia unless suffering from malignant transformation
Show all 28Show fewer
  • Active systemic fungal, viral or bacterial infection
  • Serious cardiac functional incapacity (class III or IV as defined by the New York Heart Association Classification)
  • Severe pulmonary disease (DLCO (Transfer factor of the lung for carbon monoxide) and/or FEV1 (Forced expiratory volume in 1 second) < 65%, dyspnea at rest)
  • Liver dysfunction as indicated by a total bilirubin, AST (Aspartate Aminotransferase), and ALT (Alanine aminotransferase) ≥ 2 the institutional ULN (Upper limit of normal) value, unless directly attributable to the patient's tumor
  • Creatinine clearance <50 ml/min calculated according to the modified formula of Cockcroft and Gault
  • Pregnant or lactating women
  • Active secondary malignancy requiring treatment (except basal cell carcinoma or malignant tumor curatively treated by surgery) within the last 5 years before enrollment.
  • Medical condition requiring prolonged use of systemic corticosteroids (> 1 month)
  • Prior therapy with genetically modified substances
  • Use of anti-CD20 antibodies within 4 weeks before leukapheresis
  • Chemotherapy within 4 weeks prior to leukapheresis
  • Other treatment within 4 weeks or two half-lives, whichever is longer before MB-CART20.1 infusion. This pertains to immunomodulatory therapies such as checkpoint inhibitors because of the influence on the immune system
  • Concurrent systemic radiotherapy
  • Hypersensitivity against any drug or its ingredients/impurities that is scheduled or likely to be given during trial participation e.g. as part of the mandatory lymphodepletion protocol, pre-medication for infusion, rescue medication/salvage therapies for treatment of related toxicities
  • Patients in which such medication is contraindicated for other reasons than hypersensitivity (e.g. live vaccines and fludarabine)
  • Patients in which trial related procedures are contraindicated as judged by the investigator, e.g. lumbar punctures for CSF (Cerebrospinal fluid) sampling
  • Patient's lack of accountability, inability to appreciate the nature, meaning and consequence of the trial and to formulate his/her own wishes correspondingly
  • Patients who have a relationship of dependence or employer employee relationship to the sponsor or the investigator
  • Committal to an institution on judicial or official order
  • Cerebral dysfunction, legal incapacity
  • Other investigational treatment within 4 weeks before IMP (Investigational Medicinal Product) infusion
  • Clinically relevant autoimmune diseases or history of autoimmune disease

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • University Hospital of Cologne - Clinic for Internal Medicine I

    Cologne, 50937

  • Universitätsklikum Leipzig, AöR

    Leipzig

Other trials in Germany

About this study

Official title: A Phase I/II Safety, Dose Finding and Feasibility Trial of MB-CART20.1 in Patients with Relapsed or Resistant CD20 Positive B-NHL

This trial is a phase I/II trial to assess safety, dose finding and feasibility of ex vivo generated MB-CART20.1 cells in patients with relapsed or refractory CD20 positive B-NHL.

Read the detailed description

MB-CART20.1 consists of autologous Anti-CD20 Chimeric Antigen Receptor (CAR) transduced CD4 /CD8 enriched T cells targeting CD20-positive tumor cells in Non-Hodgkin-Lymphoma (NHL)

Being tested
MB-CART20.1
Medical subject headings
Recurrence, Lymphoma, B-Cell, Lymphoma, Non-Hodgkin

What participants receive

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

  • MB-CART20.1Biological

    Also called CD20-targeting CAR T Cells, Anti-CD20 CAR T cells

    MB-CART20.1 consists of autologous CD20 Chimeric Antigen Receptor (CAR) transduced CD4 /CD8 enriched T cells targeting CD20-positive tumor cells in NHL

Study groups in NCT03664635
Study groupRoleWhat they receive
Phase I - Safety Dose LevelExperimentalIn phase I three (3) + 3 patients will be treated with 1x10^5 MB-CART20.1 cells per kg body weight administered intravenously as single dose in the preceding safety dose level
Receives: Biological: MB-CART20.1
Phase I - Dose Level 1ExperimentalIn phase I six (6) + 3 patients will be treated with 1x10^6 MB-CART20.1 cells per kg body weight administered intravenously as single dose in the dose level 1
Receives: Biological: MB-CART20.1
Phase I - Dose Level 2ExperimentalIn phase I six (6) + 3 patients will be treated with 3x10^6 MB-CART20.1 cells per kg body weight administered intravenously as single dose in the dose level 2
Receives: Biological: MB-CART20.1
Phase IIExperimentalThe number of additional patients who will be treated with MB-CART20.1 cells in Phase II is depending on the number of evaluable patients treated with the maximum tolerated dose (MTD) level and the results in Part I
Receives: Biological: MB-CART20.1

What is being measured

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

  1. Phase I - Determination of the maximum tolerated dose (MTD)

    MTD is defined as the highest dose level at which < 33% of patients experience Dose Limiting Toxicity (DLT). Safety and toxicity assessment of MB-CART20.1 per adverse events (AE) reporting classified according to CTCAE version 5.0.

    Measured: until day 28 after infusion of MB-CART20.1

  2. Phase II - Best overall response rate

    Response (Complete response (CR), Partial response (PR), Stable disease (SD), Progressive disease (PD)) is defined according to Cheson criteria.

    Measured: 3 months after infusion of MB-CART20.1

Secondary outcomes (13)

  1. Phase I - Related safety and toxicity of MB-CART20.1

    Per adverse events (AE) reporting classified according to CTCAE version 5.0.

    Measured: months 3, 6, 9 and 12 after infusion of MB-CART20.1

  2. Phase I - Best overall response rate over 4 weeks and 3 months

    Response (CR, PR, SD and PD) is defined according to Cheson criteria.

    Measured: 4 weeks and 3 months after infusion of MB-CART20.1

  3. Phase I - Best overall response rate over 1 year

    Response (CR, PR, SD and PD) is defined according to Cheson criteria.

    Measured: 1 year after infusion of MB-CART20.1

  4. Phase I - Occurrence of B-cell aplasia

    Circulating B cell numbers in the peripheral blood will be assessed by Flow cytometry.

    Measured: 1 year after infusion of MB-CART20.1

  5. Phase I - Phenotype and Persistence of MB-CART20.1

    Blood samples for determination of persistence/phenotyping of infused MB-CART20.1 will be analysed.

    Measured: 1 year after infusion of MB-CART20.1

  6. Phase II - Best overall response rate over 1 year

    Response (CR, PR, SD and PD) is defined according to Cheson criteria.

    Measured: 1 year after infusion of MB-CART20.1

  7. Phase II - Overall response rate over 4 weeks and 3 months

    Response (CR, PR, SD and PD) is defined according to Cheson criteria.

    Measured: 4 weeks and 3 months after infusion of MB-CART20.1

  8. Phase II - Overall response rate over 1 year

    Response (CR, PR, SD and PD) is defined according to Cheson criteria.

    Measured: 1 year after infusion of MB-CART20.1

  9. Phase II - Number of patients with CR, PR, SD and PD

    Response (CR, PR, SD and PD) is defined according to Cheson criteria.

    Measured: 1 year after infusion of MB-CART20.1

  10. Phase II -Percentage of patients with CR, PR, SD and PD

    Response (CR, PR, SD and PD) is defined according to Cheson criteria.

    Measured: 1 year after infusion of MB-CART20.1

  11. Phase II - Safety and toxicity assessment of MB-CART20.1

    Per adverse events (AE) reporting classified according to CTCAE version 5.0.

    Measured: 1 year after infusion of MB-CART20.1

  12. Phase II - Occurrence of B-cell aplasia

    Circulating B cell numbers in the peripheral blood will be assessed by Flow cytometry.

    Measured: 1 year after infusion of MB-CART20.1

  13. Phase II - Phenotype and Persistence of MB-CART20.1

    Blood samples for determination of persistence/phenotyping of infused MB-CART20.1 will be analysed.

    Measured: 1 year after infusion of MB-CART20.1

Timeline

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

  1. First posted10 Sep 2018
  2. Study start25 Sep 2018
  3. Primary completion17 Sep 2024
  4. Study completion17 Sep 2024

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03664635
Sponsor's protocol ID
M-2016-312
Status last verified
Nov 2024
First submitted
3 Sep 2018
Last updated
21 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MB-CART20.1 in people with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma and Non-Hodgkin's Lymphoma, run by Miltenyi Biomedicine GmbH at 2 sites in Germany.

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 7 inclusion and 28 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: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Phase I - Determination of the maximum tolerated dose (MTD) (time frame: until day 28 after infusion of MB-CART20.1). The study lists 2 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 NCT03664635.

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 21 Nov 2024.

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