LeukemiaPhase 1/2STP-LYM-01NCT01138579
Study of the Trifunctional Antibody FBTA05 and Donor Lymphocyte Infusion in B-cell Lymphoma After Allogeneic Stem Cell Transplantation
A Phase 1/2 study testing FBTA05 in people with Leukemia and Stem Cell Transplantation, run by Technical University of Munich at 1 site in Germany.
Trial summary
This study is an investigator driven, open-label, non-randomized, uncontrolled, dose escalating Phase I/II study evaluating the safety and preliminary efficacy of the trifunctional bispecific antibody FBTA05 in combination with donor lymphocyte infusions (DLI) for treatment of relapsed or refractory disease in CD20… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Stem Cell Transplantation
- What is being tested?
- FBTA05
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2010to Jun 2015
- 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
- Patient´s written informed consent
- ≥ 18 years of age; male and female
- Confirmed CLL, low grade NHL or high grade NHL on standard histological or immunophenotypical criteria described in the WHO classification of lymphoid malignancies
- CD20 positivity (if not already confirmed)
- Adequate haematological, liver and kidney functions
- Platelet count ≥25,000mm³ (=25 x 10^9/l)
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- Patients with active disease (relapsed/refractory) that survived at least 60 days after allogeneic transplantation
- Eastern Cooperative Oncology Group (ECOG) performance status <=2 (Appendix IV)
- Negative pregnancy test (no more than 2 days before enrolment) and adequate contraception during the study in women of child bearing potential (pre- menopausal, <2 years post-menopausal or not surgically sterile)
Who cannot join
- Any anti-CD20 and / or any other anti-T cell directed antibody treatments < 3 months before application of FBTA05
- Positivity for human anti-mouse antibodies (HAMAs)
- History of GvHD ° III or IV, or GvHD requiring steroid therapy with more than 10 mg/day
- Known or suspected hypersensitivity to recombinant, murine or rat proteins
- AST/SGOT greater than 10 x ULN (grade 3, CTCAE)
- Bilirubin greater than 5 x ULN (grade 3, CTCAE)
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- Creatinine greater than 3.5 mg/dl (grade 3, CTCAE)
- Acute or uncontrolled chronic infections, viral infections at risk of reactivation (e.g.HCV, HBV, HIV)
- Unable or unwilling to comply fully with the protocol
- Any condition which in the judgement of the Investigator would place the subject at undue risk or interfere with the results of the study
Trial locations and contacts
1 site in 1 country.
Germany1 site
3. Medizinische Klinik, Klinikum rechts der Isar der TU München
Munich, Bavaria
About this study
Official title: Phase I/II Dose-escalation Study of the Investigational Trifunctional Bispecific Anti-CD20 x Anti-CD3 Antibody FBTA05 in Combination With Donor Lymphocyte Infusion (DLI) in Patients With CD20 Positive Chronic Lymphocytic Leukemia (CLL), Low and High Grade Non-Hodgkin´s Lymphoma (NHL) After Allogeneic Stem Cell Transplantation
This study is an investigator driven, open-label, non-randomized, uncontrolled, dose escalating Phase I/II study evaluating the safety and preliminary efficacy of the trifunctional bispecific antibody FBTA05 in combination with donor lymphocyte infusions (DLI) for treatment of relapsed or refractory disease in CD20 positive either low- or high-grade non-Hodgkin´s lymphoma after allogeneic transplantation
- Conditions
- Leukemia, Stem Cell Transplantation
- Being tested
- FBTA05
- Keywords
- FBTA05, CD20, CLL, NHL, DLI, allogeneic transplantation, CD20 positive chronic lymphocytic leukemia (CLL), low and high grade non-Hodgkin´s lymphoma (NHL) after allogeneic stem cell transplantation with active disease
- Medical subject headings
- Leukemia, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FBTA05Drug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: FBTA05 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Determination of the maximum tolerated dose (MTD)
Phase II: Evaluation of preliminary efficacy of FBTA05 in combination with DLI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2010 (estimated)
- Study startAug 2010 (estimated)
- Primary completionMay 2015 (estimated)
- Study completionJun 2015 (estimated)
Why it stopped: Recruitment delayed, trial medication no loner available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01138579
- Sponsor's protocol ID
- STP-LYM-01-V01
- Acronym
- STP-LYM-01
- Status last verified
- Dec 2015
- First submitted
- 4 Jun 2010
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.
PubMed 34515338Buhmann R, Michael S, Juergen H, Horst L, Peschel C, Kolb HJ. Immunotherapy with FBTA05 (Bi20), a trifunctional bispecific anti-CD3 x anti-CD20 antibody and donor lymphocyte infusion (DLI) in relapsed or refractory B-cell lymphoma after allogeneic stem cell transplantation: study protocol of an investigator-driven, open-label, non-randomized, uncontrolled, dose-escalating Phase I/II-trial. J Transl Med. 2013 Jul 2;11:160. doi: 10.1186/1479-5876-11-160.
PubMed 23815981
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Dose-escalation Study of the Investigational Trifunctional Bispecific Anti-CD20 x Anti-CD3 Antibody FBTA05 in Combination With Donor Lymphocyte Infusion (DLI) in Patients With CD20 Positive Chronic Lymphocytic Leukemia (CLL), Low and High Grade Non-Hodgkin´s Lymphoma (NHL) After Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT01138579
- Acronym / sponsor ID
- STP-LYM-01 / STP-LYM-01-V01
- Conditions
- Leukemia, Stem Cell Transplantation
- Keywords
- FBTA05, CD20, CLL, NHL, DLI, allogeneic transplantation, CD20 positive chronic lymphocytic leukemia (CLL), low and high grade non-Hodgkin´s lymphoma (NHL) after allogeneic stem cell transplantation with active disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment delayed, trial medication no loner available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Aug 2010 (estimated)
- Primary completion
- May 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 7 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an investigator driven, open-label, non-randomized, uncontrolled, dose escalating Phase I/II study evaluating the safety and preliminary efficacy of the trifunctional bispecific antibody FBTA05 in combination with donor lymphocyte infusions (DLI) for treatment of relapsed or refractory disease in CD20 positive either low- or high-grade non-Hodgkin´s lymphoma after allogeneic transplantation
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: FBTA05 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient´s written informed consent
- ≥ 18 years of age; male and female
- Confirmed CLL, low grade NHL or high grade NHL on standard histological or immunophenotypical criteria described in the WHO classification of lymphoid malignancies
- CD20 positivity (if not already confirmed)
- Adequate haematological, liver and kidney functions
Key exclusion criteria (10 listed)
- Any anti-CD20 and / or any other anti-T cell directed antibody treatments < 3 months before application of FBTA05
- Positivity for human anti-mouse antibodies (HAMAs)
- History of GvHD ° III or IV, or GvHD requiring steroid therapy with more than 10 mg/day
- Known or suspected hypersensitivity to recombinant, murine or rat proteins
- AST/SGOT greater than 10 x ULN (grade 3, CTCAE)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FBTA05 | Drug | 1 |
Primary outcome
Phase I: Determination of the maximum tolerated dose (MTD)
Phase II: Evaluation of preliminary efficacy of FBTA05 in combination with DLI
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Derived from this study: PubMed 34515338Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.
- Derived from this study: PubMed 23815981Buhmann R, Michael S, Juergen H, Horst L, Peschel C, Kolb HJ. Immunotherapy with FBTA05 (Bi20), a trifunctional bispecific anti-CD3 x anti-CD20 antibody and donor lymphocyte infusion (DLI) in relapsed or refractory B-cell lymphoma after allogeneic stem cell transplantation: study protocol of an investigator-driven, open-label, non-randomized, uncontrolled, dose-escalating Phase I/II-trial. J Transl Med. 2013 Jul 2;11:160. doi: 10.1186/1479-5876-11-160.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing FBTA05 in people with Leukemia and Stem Cell Transplantation, run by Technical University of Munich at 1 site 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 9 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: withdrawn, as of the sponsor's last update on 7 Dec 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 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 was withdrawn before enrolling participants, so there are no results.
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). 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 NCT01138579, which also lists 2 linked publications.
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 7 Dec 2022.