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Tests treatment safety and results for Neoplasms
Official title 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
ClinicalTrials.gov ID: NCT05836896
What this study is testing
What is MDC-CAR-BCMA001 (BCMA directed CAR T-cells)?
MDC-CAR-BCMA001 (BCMA directed CAR T-cells) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for neoplasms.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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):
You likely can't join if
- 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...
- Inadequate pulmonary function (i.e. need for continuous oxygen support)
- Patients on hemodialysis
See the full eligibility criteria
Who can 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...
- 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...
- 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...
- 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...
- 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...
What rules you out
- 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
- 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...
- 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 treatment 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).
The study team makes the final eligibility decision.
Where it's taking place
- Dresden, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dresden, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.