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NeoplasmsPhase 1CARLOTTA01NCT05836896

A Phase I Trial to Establish the Safety and Maximum Tolerated Dose of High-affinity Autologous BCMA-targeting Chimeric Antigen Receptor (CAR) T-cells in Patients With Relapsed and Refractory B-cell Malignancies

A Phase 1 study testing MDC-CAR-BCMA001 (BCMA directed CAR T-cells) in people with Neoplasms and Relapsed Diffuse Large B-cell Lymphoma (DLBCL), run by Technische Universität Dresden at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this phase I study is to determine whether MDC-CAR-BCMA001 (BCMA directed CAR T-cells) is safe and tolerable in the treatment of relapsed and refractory B-cell malignancies Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MDC-CAR-BCMA001 (BCMA directed CAR T-cells)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteGermany
Study dates
15 Feb 2024to Jun 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

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

  • Male or female patients aged ≥ 18 years
  • Written informed consent of the subject
  • Able and willing to adhere to the trial protocol
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Either Multiple Myeloma (MM):
  • relapsed or refractory disease after at least 2 lines of treatment including an Immunomodulatory drug, a proteasome inhibitor and an anti-cluster of differentiation 38 antibody or anti-cluster of differentiation 319 (SLAMF7; Elotuzumab) antibody AND
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  • not eligible for treatment with other regimen available according to local standard of care and known to confer clinical benefit according to the investigator's discretion, prior treatment with other BCMA-targeting immunotherapies (including T-cell engaging antibodies, CAR T-cells and antibody-drug immuno-conjugates) is allowed AND
  • measurable disease defined by serum M-Protein ≥ 10 g/l OR urine M-Protein ≥ 200 mg/24h OR serum free light chain > 100 mg/l of involved free light chain and abnormal serum free light chain ratio
  • OR
  • Diffuse large B-cell lymphoma (DLBCL):
  • Relapsed after or refractory to standard curative therapy (such as R-CHOP) and refractory to at least one course of standard salvage chemotherapy OR
  • Relapsed within one year after high-dose chemotherapy and autologous stem cell support OR
  • Relapsed after allogeneic stem-cell transplantation or approved anti-cluster of differentiation 19 CAR T-cell therapies.
  • AND (applicable to all DLBCL patients)
  • Not be eligible for treatment with other regimen available according to local standard of care and known to confer clinical benefit. This includes but is not limited to anti-cluster of differentiation 19 directed CAR T-cell therapies with approved constructs AND (applicable to all DLBCL patients)
  • Measurable disease according to Lugano criteria
  • Adequate organ function defined as:
  • Neutrophils ≥ 0.5 Gpt/l and Platelets ≥ 50 Gpt/l (unless due to subtotal infiltration of the bone marrow by underlying malignancy)
  • Lymphocytes ≥ 0.1 Gpt/l
  • Alaninaminotransferase and Asparataminotransferase ≤ 3.0x Upper limit of normal
  • Bilirubin ≤ 1.5x Upper limit of normal
  • Creatinine ≤ 1.5x Upper limit of normal
  • Adequate cardiac function i.e. left ventricular ejection fraction ≥ 50%, no major valve abnormalities or dyskinesias
  • A female of childbearing potential* may be enrolled providing she has a negative pregnancy test at screening and is routinely using a highly effective method of birth control (pearl index of ≤ 1 required) resulting in a low failure rate (e.g. hormonal contraception, intrauterine device, total sexual abstinence or sterilization). Male patients must also prac-tice a highly effective method of birth control and should not father a child at least until 12 months after infusion of CAR T-cells

Who cannot join

  • Any Central nervous system (CNS)-involvement by underlying disease
  • History of seizure or cerebrovascular ischemia / hemorrhage within the last 12 months
  • History of any autoimmune Central nervous system disease (e.g. multiple sclerosis, amyotrophic lateral sclerosis, optic neuritis)
  • Ongoing neurologic conditions that in the opinion of the investigator might increase the risk for neurotoxicity or impair the assessment of CAR-associated neurotoxicity
  • Inadequate pulmonary function (i.e. need for continuous oxygen support)
  • Patients on hemodialysis
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  • Any contraindications to Fludarabine and/or Cyclophosphamide as given in the Summary of product characteristics
  • Any other active malignancy requiring active treatment or interfering with the assessment of primary or secondary trial endpoints, adjuvant hormonal therapy is allowed
  • Positivity for anti-human immunodeficiency virus (HIV) immunoglobulin
  • Active or chronic infectious hepatitis B (HBV) and C (HCV) virus unless serology demonstrates clearance of infection (i.e. Polymerase chain reaction undetectable viral load for hepatitis)
  • Active infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) or history of SARS-CoV2 infection within the past 3 months or active long coronavirus disease (COVID) syndrome
  • Uncontrolled bacterial, viral or fungal infections defined as infections needing in-patient and/or i.v. antimicrobial treatment*
  • Active Graft versus Host Disease defined as active symptoms of graft-versus-host disease or ongoing immunosuppressive treatment or prophylaxis within the last 30 days prior to application of MDC-CAR-BCMA001
  • Psychologic disorders, drug abuse or any other condition which might significantly impair a patient's ability to comply with the trial protocol
  • Patients who are expected to deteriorate during the time needed for manufacturing MDC-CAR-BCMA001 in spite of bridging therapy in the opinion of the investigator including
  • Any condition requiring systemic treatment with immunosuppressive drugs (including but not limited to steroids exceeding 20 mg Prednisolone per day)
  • Any antineoplastic treatment within 7 days prior to leukapheresis or within 2 weeks or 5 half-lives (whatever is shorter) of the start of lymphodepleting chemotherapy (palliative radiotherapy to lesions not essential for response assessment is allowed without a minimal washout period)
  • Any investigational therapy within 4 weeks or 5 half-lives (whatever is shorter) prior to apheresis or the start of lymphodepleting chemotherapy
  • History of allergic reactions to any drug or its ingredients / impurities foreseen to be given as part of this trial according to the protocol*
  • Receipt of live vaccines within 2 weeks prior to leukapheresis and start of lymphodepleting chemotherapy
  • Pregnant or breastfeeding women. Breastfeeding has to be discontinued before onset of and during treatment and should be discontinued for at least 3 months after end of treatment.
  • Women of childbearing potential, except women who meet the following criteria:
  • post-menopausal (12 months natural amenorrhoea or 6 months amenorrhoea with serum Follicle stimulating hormone > 40 U/ml)
  • postoperative (6 weeks after bilateral ovariectomy with or without hysterectomy)
  • regular and correct use of a contraceptive method with an Pearl Index < 1% per year
  • sexual abstinence
  • Vasectomy of the partner
  • Hypersensitivity known from medical history to one of the drugs used or their ingredients or to drugs with a similar chemical structure
  • Simultaneous participation in another interventional clinical trial (including within the last 4 weeks before inclusion)
  • Addictions or other illnesses that do not allow the person concerned to assess the nature and extent of the clinical trial and its possible consequences
  • Indications that the subject is unlikely to adhere to the protocol (e.g., lack of compliance).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Martin Wermke, Prof. contact

+49 351 458 13408

carlotta@ukdd.de

Katja Winkler, Dr. contact

+49 351 458 13408

Germany1 site, 1 recruiting

  • Technische Universität Dresden, NCT/UCC, Early Clinical Trial Unit

    Dresden, 01307

    Martin Wermke, Prof.

    Recruiting

Other trials in Germany

About this study

Official title: A Phase I Trial to Establish the Safety and Maximum Tolerated Dose of High-affinity Autologous BCMA-targeting CAR T-cells in Patients With Relapsed and Refractory B-cell Malignancies

The purpose of this phase I study is to determine whether MDC-CAR-BCMA001 (BCMA directed CAR T-cells) is safe and tolerable in the treatment of relapsed and refractory B-cell malignancies

Being tested
MDC-CAR-BCMA001 (BCMA directed CAR T-cells)
Medical subject headings
Neoplasms, Lymphoma, Large B-Cell, Diffuse, Multiple Myeloma

What participants receive

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

  • MDC-CAR-BCMA001 (BCMA directed CAR T-cells)Genetic

    Single-dose intravenous infusion of MDC-CAR-BCMA001 at the respective dose level following a conditioning chemotherapy

Study groups in NCT05836896
Study groupRoleWhat they receive
MDC-CAR-BCMA001ExperimentalMDC-CAR-BCMA001 will be administered intravenously in ascending dose levels. This trial will test a total of 4 dose levels in order to identify the MTD and/or recommended phase 2 dose for MDC-CAR-BCMA001.
Receives: Genetic: MDC-CAR-BCMA001 (BCMA directed CAR T-cells)

What is being measured

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

  1. Maximum tolerated dose (MTD) of MDC-CAR-BCMA001

    The MTD will be defined as the dose for which the isotonic estimate of the toxicity rate is closest to the target toxicity rate.

    Measured: appr. 24 months

  2. Incidence and severity of adverse events and serious adverse events

    graded according to Common Terminology Criteria of Adverse Events V5.0

    Measured: appr. 24 months

  3. Incidence and severity of Cytokine release syndrome

    Grading of Cytokine release syndrome according to American Society for Transplantation and Cellular Therapy consensus criteria

    Measured: appr. 24 months

  4. Incidence and severity of Immune effector cell-associated neurotoxicity syndrome

    Grading of Immune effector cell-associated neurotoxicity syndrome according to American Society for Transplantation and Cellular Therapy consensus criteria

    Measured: appr. 24 months

  5. Incidence of dose-limiting toxicity (DLT) during DLT-evaluation period and beyond

    Measured: appr.24 months

Timeline

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

  1. First posted1 May 2023
  2. Study start15 Feb 2024
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (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
Sequential
Masking
None (open label)
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05836896
Sponsor's protocol ID
TUD-BCMACA-078
Acronym
CARLOTTA01
Status last verified
Aug 2026
First submitted
19 Apr 2023
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MDC-CAR-BCMA001 (BCMA directed CAR T-cells) in people with Neoplasms and Relapsed Diffuse Large B-cell Lymphoma (DLBCL), run by Technische Universität Dresden 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 24 inclusion and 31 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: looking for participants now, as of the sponsor's last update on 27 Aug 2026. 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 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Martin Wermke, Prof. (+49 351 458 13408, carlotta@ukdd.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) of MDC-CAR-BCMA001 (time frame: appr. 24 months). The study lists 5 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 NCT05836896.

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 27 Aug 2026.

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