Aktuelle Studien Abteilung Klinische Pharmakologie
Im Heidelberger Klinisch-Pharmakologischen Studienzentrum wird ein breites Spektrum von gesunden Probanden:innen bis hin zu schwer erkrankten Patient:innen betreut. Wir führen sowohl eigeninitiierte, als auch industriegesponserte Studien, vornehmlich der frühen Phasen, durch.
- Sie interessieren sich für eine Studienteilnahme als gesunder Freiwilliger? Hier finden Sie relevante Informationen.
- Sie sind Patient und sollen in unserem Klinisch-Pharmakologischen Studienzentrum behandelt werden? Erste Informationen erhalten Sie hier.
- Sie kommen aus der akademischen Forschung oder Industrie und möchten Ihre Studie in unserem Studienzentrum durchführen lassen? Informieren Sie sich auf unserer Seite für Sponsoren.
Studienteilnehmer:innen gesucht!
Eine Übersicht der Studien, für die wir aktuell (gesunde) Studienteilnehmer:innen suchen, finden Sie hier.
Kooperationsstudien am Universitätsklinikum Heidelberg
Des Weiteren werden auch Studien in Kooperation mit anderen Fachabteilungen und Partnern am Universitätsklinikum Heidelberg durchgeführt.
Hierzu gehören unter anderem:
- Hämato-onkologische Studien (Phase I-III Studien mit Fokus auf Multiplem Myelom),
- onkologische Studien zu vielen weiteren Tumorentitäten (NCT)
- Studien mit gastroenterologischer Indikation
- Studien mit kardiologischer Indikation
Studien mit pädiatrischen Patienten oder vornehmlich pneumologischer Indikation (u. a. auch Studien nach dem Medizinproduktegesetz) werden bei unseren Netzwerk-Partnern, dem pädiatrischen klinisch-pharmakologischen-Studienzentrum (paedKliPS) und dem pneumologischen klinisch-pharmakologischen Studienzentrum (ThoraxKliPS) durchgeführt.
Laufende Studien
Im Folgenden finden Sie eine Übersicht aller aktuell laufenden Studien.
| EudraCT - NUMMER | KURZTITEL | DESIGN |
|---|---|---|
| freie Studie | Genotype - Biobank | DNA Biobank for Genotype Screening of Volunteers for the Participation in Clinical Studies |
| 2017‐003448‐19/2023-506564-14 | CC-93269-MM-001 (Engmab) | Phase 1, open-label, dose finding study of CC-93269, A BCMA X CD3 T cell engaging antibody, in subjects with relapsed and refractory multiple myeloma |
| 2021-002584-22 | PANHPVAX | first-in-human, phase I, single-center, open-label, dose-escalation trial in healthy volunteers to assess safety, tolerability, and immunogenicity of PANHPVAX, a vaccine targeting human papilloma L2 antigen formulated with cyclic di-AMP |
| 2019-001213-17 | Myr301 | A Multicenter, Open-label, Randomized Phase 3 Clinical Sudy to Assess Efficacy and Safety of bulevirtide in Patients with Chronic Hepatitis Delta |
| 2018-004767-31 | CC92480-MM-002 | Phase 1/2 multicenter, open-label, study to determine the recommended dose and regimen, and evaluate the safety and preliminary efficacy of CC-92480 in combination with standrad treatments in subjcets with with relapsed and refractory multiple myeloma (RRMM) and newly diagnosed multiple myeloma (NDMM) |
| 2019-001932-80 | NI006-Studie | A Phase I, First in Human, Double-Blind, Placebo-Controlled, Multicenter, Single and Multiple Ascending Dose Study of NI006 in Patients with Amyloid Transthyretin Cardiomyopathy followed by an Open-Label-Extension |
| 2019-001743-48 | WVT078 | A Phase I, open-label, multicenter, study of WVT078 in subjects with relapsed and/or refractory multiple myeloma |
| 2019-000330-19 | TRIMM 2 | Phase 1b Study of Subcutaneous Daratumumab Regimens in Combination with Bispecific T Cell Redirection Antibodies for the Treatment of Subjects with Multiple Myeloma |
| 2018-004154-25 | Panorama -OLE PK015 | A multicenter study to evaluate long-term safety and tolerability of open label sacubitril/valsartan in pediatric patients with heart failure due to systemic left ventricle systolic dysfunction who have completed study CLCZ696B2319 |
| 2017-002400-26 | Talmmy | A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects with Relapsed or Refractory Multiple Myeloma |
| 2022-001096-13 | Bempedoinsäure | Effect of staggered vs. simultaneous open-label administration on the pharmacokinetics of pravastatin and bempedoic acid in healthy volunteers |
| 2020-003414-12 | Heidelberg Pharma | A Phase 1/2a, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HDP-101 in Patients with Plasma Cell Disorders Including Multiple Myeloma |
| 2018-004354-21 | DREAMM8 | A Phase III, Multicenter, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination with Pomalidomide and Dexamethasone (B-Pd) versus Pomalidomide plus Bortezomib and Dexamethasone (PVd) in Participants with Relapsed/Refractory Multiple Myeloma (DREAMM 8) |
| freie Studie | Healthy Vol | Screening von gesunden Freiwilligen: Evaluation und Optimierung eines Schlüsselprozesses für Klinische Prüfungen der Phase 0/I |
| 2022-000928-37 | MajesTec-9 | A Phase 3 Randomized Study Comparing Teclistamab Monotherapy versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants with Relapsed or Refractory Multiple Myeloma who have Received 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Monoclonal Antibody and Lenalidomide |
| 2022-003679-40 | Helicase | Phase 1 clinical trial to evaluate the safety, tolerability, and pharmacokinetics of single doses of IM-250 in healthy volunteers |
| 2021-005073-22 | TRIMM-3 | Phase 1b Study of Bispecific T Cell Redirection Antibodies in Combination with Checkpoint Inhibition for the Treatment of Participants with Relapsed or Refractory Multiple Myeloma |
| 2020-000384-23 | BI 764198 | A multicenter, randomized, double-blind, parallel group, placebo-controlled study to assess safety, tolerability, pharmacokinetics and pharmacodynamics of BI 764198 administered orally once daily for 12 weeks in patients with focal segmental glomerulosclerosis. |
| 2021-006226-49 | NN6019 | Efficacy and safety of NNC6019-0001 at two dose levels in participants with transthyretin amyloid cardiomyopathy (ATTR CM) |
| 2023-504405-37-00 | TacroBiom | Assessment of the influence of the gut microbiome on tacrolimus pharmacokinetics in healthy volunteers |
| compassionate use | Tecli Compassionate | Named Patient Program (NPP) 64007957MMY4001 PRE-APPROVAL ACCESS (PAA) for Teclistamab (JNJ-64007957) |
| 2022-000261-40 | NUC-011/BIO | Pharmacokinetic (PK) study to investigate the pharmacokinetic profile of Norucholic acid (NCA) in primary sclerosing cholangitis (PSC) patients treated with NCA capsules within open-label-extension (OLE) NUC-5/PSC study (Satellite NUC-5/PSC study) |
| 2019-000613-36 | DODEKA | A phase I study to evaluate safety and early signs of efficacy of the human monoclonal antibody-cytokine fusion protein IL12-L19L19. |
| 2021-003999-14 | ALE100_Janssen | A Phase 1b Study of JNJ-75276617 in Combination with AML Directed Therapies for Participants with Acute Myeloid Leukemia Harboring KMT2A or NPM1 Alterations |
| 2022-003790-38 | LipOra | Phase 1, first-in-human trial to evaluate the safety, tolerability, and pharmacokinetics of ascending single oral doses of octreotide/ LipOra peptide in healthy volunteers |
| 2021-000202-22 | MonumenTAL3 | A Phase 3 Randomized Study Comparing Talquetamab SC in Combination With Daratumumab SC and Pomalidomide (Tal-DP) or Talquetamab SC in Combination with Daratumumab SC (Tal-D) versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd) |
| 2021-003380-95 | CDYP688A12101 | A Phase I/II, multi-center, open label study of DYP688 in patients with metastatic uveal melanoma (MUM) and other GNAQ/11 mutant melanomas |
| 2022-503133-54-00 | IMA402-Prame | A Phase I/II First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Anti-Tumor Activity of IMA402, a Bispecific T Cell-Engaging Receptor Molecule (TCER®) targeting PRAME, in Patients with Recurrent and/or Refractory Solid Tumors |
| 2019-004046-16/2022-502684-37-00 | IMCF106C-101 | A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-F106C as a Single Agent and in Combination with Checkpoint Inhibitors in HLA-A*02:01-Positive Participants with Advanced PRAME-Positive Cancers |
| 2022-003452-14 | BC 007/BLOC | A prospective, double-blind, randomized, parallel group, placebo-controlled, multicentre, Phase II study to investigate the efficacy, GPCR autoantibody-neutralizing effect, safety, and tolerability of BC 007 in participants with long COVID |
| 2022-502446-27 | MonumenTAL-6 | A Phase 3 Randomized Study Comparing Talquetamab in Combination with Pomalidomide (Tal-P), Talquetamab in Combination with Teclistamab (Tal-Tec), and Investigator’s Choice of Either Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pomalidomide, Bortezomib, and Dexamethasone (PVd) in Participants with Relapsed or Refractory Myeloma who Have Received 1 to 4 Prior Lines of Therapy Including an Anti-CD38 Antibody and Lenalidomide |
| 2023-506669-70 | DepleTTR-CM | A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Amyloid Depleter ALXN2220 in Adult Participants with Transthyretin Amyloid Cardiomyopathy (ATTR-CM) |
