Authorised Phase I and Phase II (Integrated)- First administration to humans Multiple myeloma.

Trial of an investigational drug after the rejection of an allogeneic transplant.

EU CTIS ID: 2022-503063-15-00

What this study is testing

Assess the feasibility of generating HUVR-CARTemis-1 and its safety in terms of maximum tolerated dose in patients with multiple myeloma in 1st or successive relapses after allogeneic transplant.

  • Phase I and Phase II (Integrated)- First administration to humans

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 1. Patients > 18 years old with a diagnosis of post-allogeneic transplant relapse multiple myeloma. 2. Medical illness 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 GVHD. 5. ECOG functional status from 0 to 1. 6. Life expectancy greater than 3 months 7. Patients who give their consent by signing the Informed Consent document.

You likely can't join if

  • 1. Active systemic immunosuppressive therapy. 2. Patients who have previously received CAR-T Anti-BCMA treatment. Patients who have received another type of anti-BCMA therapy will not be excluded, although in this case the positivity for BCMA in myeloma cells must be confirmed at the time of inclusion. 3. Absolute lymphocyte count <0.2x109/L. 4. Previous malignancy, except if in complete remission >3 years, with the exception of cutaneous carcinoma (non-melanoma). 5. Active infection requiring treatment. 6. Active HIV, HBV, or HCV infection. 7. Uncontrolled medical illness. 8. Severe organic disease that meets any of the following criteria: EF <40%, DLCO < 40%, GFR < 50 ml/min, bilirubin > 3 NV (except Gilbert's syndrome). 9. Previous diagnosis of symptomatic AL amyloidosis or POEMS syndrome. 10. Pregnant or lactating women. 11. Women of childbearing potential who are unable or unwilling to use highly effective contraceptive methods 12. Men unable or unwilling to use highly effective contraceptive methods 13. Contraindication to receive lymphodepletive chemotherapy.

The study team makes the final eligibility decision.

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, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.