Avastin (bevacizumab) • cisplatin • carboplatin • gemcitabine • paclitaxel • docetaxel • pemetrexed • Libtayo (cemiplimab-rwlc) • MaaT033 • Navelbine oral (vinorelbine tartrate oral)

8ms

Gut microbiota restoration with oral pooled fecal microbiotherapy after intensive chemotherapy: the phase Ib CIMON trial. (PubMed, Blood Adv)

The purpose of this dose-ranging phase I study (CIMON) was to evaluate the first-in-man use of MaaT033, a pooled, allogeneic, lyophilized, and standardized fecal microbiotherapeutic product, formulated as a delayed-release capsule for oral administration...Moreover, inflammatory markers (C-reactive protein, interleukin-6) decrease with treatment, while short-chain fatty acids increase over time. A randomized, placebo-controlled phase IIb trial, in recipients of alloHCT patients in ongoing.

8 months ago

P1 data • Journal

IL6 (Interleukin 6) • CRP (C-reactive protein)

MaaT033

11ms

Oral Pooled Fecal Microbiotherapy to Prevent Allogeneic Hematopoietic Cell Transplantation Complications (PHOEBUS Trial) (clinicaltrials.gov)

P2, N=387, Recruiting, MaaT Pharma | Phase classification: P2b --> P2

11 months ago

Phase classification

MaaT033

over1year

IASO: Safety and Gut Microbiota Analysis of an Oral Microbiotherapy in Patients With Amyotrophic Lateral Sclerosis (clinicaltrials.gov)

P1, N=15, Active, not recruiting, MaaT Pharma | Recruiting --> Active, not recruiting

over 1 year ago

Enrollment closed

MaaT033

2years

IASO: Safety and Gut Microbiota Analysis of an Oral Microbiotherapy in Patients With Amyotrophic Lateral Sclerosis (clinicaltrials.gov)

P1, N=15, Recruiting, MaaT Pharma | Phase classification: P1b --> P1 | Trial completion date: Jun 2024 --> Dec 2024 | Trial primary completion date: Mar 2024 --> Sep 2024

2 years ago

Phase classification • Trial completion date • Trial primary completion date

MaaT033

2years

Oral Pooled Fecal Microbiotherapy to Prevent Allogeneic Hematopoietic Cell Transplantation Complications (PHOEBUS Trial) (clinicaltrials.gov)

P2b, N=387, Recruiting, MaaT Pharma | Not yet recruiting --> Recruiting

2 years ago

Enrollment open

MaaT033

over2years

Oral Pooled Fecal Microbiotherapy to Prevent Allogeneic Hematopoietic Cell Transplantation Complications (PHOEBUS Trial) (clinicaltrials.gov)

P2b, N=387, Not yet recruiting, MaaT Pharma | Trial completion date: Oct 2026 --> Jan 2027 | Initiation date: Jun 2023 --> Sep 2023

over 2 years ago

Trial completion date • Trial initiation date

MaaT033

almost3years

RESTORATION OF GUT MICROBIOTA DIVERSITY WITH ORAL POOLED FECAL MICROBIOTHERAPY IN ACUTE MYELOID LEUKEMIA PATIENTS AFTER INTENSIVE CHEMOTHERAPY: THE PHASE 1B CIMON TRIAL (EBMT 2023)

The CIMON study results show that MaaT033 is safe, well tolerated and effective for gut microbiota restoration in AML patients receiving IC and ATB. A Phase II trial is planned to evaluate MaaT033 in preventing alloHCT complications.

almost 3 years ago

Clinical • P1 data • Gut Microbiota

IL2 (Interleukin 2) • TGFB1 (Transforming Growth Factor Beta 1)

MaaT033

3years

Restoration of Gut Microbiota Diversity with Oral Pooled Fecal Microbiotherapy in Acute Myeloid Leukemia Patients after Intensive Chemotherapy: The Phase 1b Cimon Trial (ASH 2022)

For IC, 20 patients received cytarabine associated with an anthracycline, 1 patient received azacytidine. Conclusion The CIMON study results show that MaaT033 is safe, well tolerated and effective for gut microbiota restoration in AML patients receiving IC and ATB. A Phase II/III trial is planned to evaluate MaaT033 in preventing allo-HSCT complications.

3 years ago

Clinical • P1 data

IL2 (Interleukin 2)

cytarabine • azacitidine • MaaT033