Clinical Trials in Spain / NCT05982275
Starting soon
Phase 1/2
Trial of an Investigational Drug After Rejecting the Relapse of an Allogeneic Transplant
NCT05982275 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Multiple MyelomaAllogeneic Stem Cell Transplantation
Investigational drug(s) / intervention(s)
CARTemis-1
CARTemis-1: A dose escalation design will be applied in successive patient cohorts until identification of Dose Limiting Toxicity (maximum dose: 6x10\^6 CAR-T/kg divided over 2 days).
Study summary
Most patients with multiple myeloma (MM) die due to relapse resistant to current treatment, including treatment with anti-B cell maturation antigen (BCMA) CAR-T cells. To overcome some of the potential limitations of this therapy, a new and optimized Anti-BCMA CAR-T has been developed, with the aim of using it in patients with MM who relapse after Allogeneic Haematopoietic Haematopoietic Progenitor. This trial is a prospective phase I/II trial with a 3+3 design. Once Dose Limiting Toxicity is identified, Phase II will begin to assess the efficacy of the procedure.
Eligibility
Inclusion Criteria:
1. Patients \> 18 years old with a diagnosis of post-allogeneic transplant relapse multiple myeloma.
2. Measurable disease at the time of screening
3. Previous treatment with ≥2 lines before and/or after allogeneic transplant.
4. Patients who are not receiving immunosuppressants at least 1 month before inclusion and who do not have active graft-versus-host disease.
5. Eastern Cooperative Oncology Group functional status from 0 to 1.
6. Life expectancy greater than 3 months (at the time of screening)
7. Patients who give their consent by signing the Informed Consent document.
Exclusion Criteria:
1. Active systemic immunosuppressive treatment
2. Patients who have previously received treatment with CAR-T Anti-BCMA.
3. Absolute lymphocyte count \<0.2x109/L
4. Previous neoplasm, except if it has been in complete remission \>3 years, with the exception of skin carcinoma (non-melanoma)
5. Active infection requiring treatment.
6. Active HIV, hepatitis B virus or hepatitis C virus infection.
7. Uncontrolled medical illness.
8. Severe organic disease that meets any of the following criteria: left ventricular ejection fraction \<40%, carbon monoxide diffusion test \<40%, glomerular filtration rate \<50 ml/min, bilirubin \>3 normal value (except Gilbert syndrome).
9. Previous diagnosis of symptomatic amyloid light chain or primary amyloidosis or POEMS Syndrome.
10. Pregnant or lactating women.
11. Women of childbearing age, unable or unwilling to use highly effective contraceptive methods.
12. Men who cannot or do not wish to use highly effective contraceptive methods. The partner of the male participants, if they are women of childbearing age, must also use highly effective contraceptive methods during the study period.
13. Contraindication to receive lymphodepleting chemotherapy.
14. Patients with known hypersensitivity to the active ingredients or any of the excipients of the product to be infused.
Primary outcome measure(s)
- Purity of CARTemis-1 — Immediately after infusion
Number of cases in which, after performing apheresis, the manufacturing process is completed and CARTemis-1 cells are infused - Maximum tolerated dose — Up to 30 days
To determine the maximum tolerated dose of CarTemis-1 - Infusion reactions — Immediately after intravenous administration of CARTemis-1
To appearance of any of the following symptoms after intravenous administration of CARTemis-1: cardiac events, chills, dyspnea, fatigue, sudden hypertension, hypotension, nausea, pain, fever, skin rash, and urticaria. - Tumor lysis syndrome — Up to 30 days after treatment administration
To increase nucleic acids, potassium, and phosphate in the blood - Serious Adverse Event — Up to 36 months after treatment administration
Type, incidence, severity (graded by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0), timing, intensity, and relatedness of adverse events). - Suspected Unexpected Serious Adverse Reaction — Up to 36 months after treatment administration
Describe the adverse event that occurs in a clinical trial subject, which is assessed by the sponsor and or study investigator as being unexpected, serious and as having a reasonable possibility of a causal relationship with the study drug.
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| Hospital Universitario Marques de Valdecilla | Santander | Cantabria | |
| Hospital Santa Creu i Sant Pau | Barcelona | Spain | |
| Complejo asistencial universitario de Salamanca | Salamanca | Spain | |
| José Antonio Pérez Simón | Seville | Spain | |
| Hospital Clínico de Valencia | Valencia | Spain |
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Other trials for the same condition
A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
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A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05982275 on ClinicalTrials.gov ↗ ← All trials in Spain